PRO-YOU: Programs To Support You During Chemotherapy

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT02489422
Collaborator
National Cancer Institute (NCI) (NIH), National Center for Complementary and Integrative Health (NCCIH) (NIH)
44
Enrollment
2
Locations
2
Arms
41
Duration (Months)
22
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This randomized pilot trial studies how well two supportive programs work for improving fatigue and depressive symptoms in patients with GI undergoing chemotherapy. Possible mediators such as psychological stress, circadian disruption, and inflammation, will also be explored.

Detailed Description

PRIMARY OBJECTIVES:
  1. To conduct a pilot randomized controlled trial of the yoga skills training (YST) versus a caring attention control (AC) group among adults with colorectal cancer (CRC) receiving chemotherapy to determine preliminary efficacy for the primary outcome of fatigue, secondary outcome of depressive symptoms, and possible mediators (i.e., psychological stress, circadian disruption, inflammation) as assessed by standard measures.
SECONDARY OBJECTIVES:
  1. To measure the impact of the YST versus the AC on daily assessments of fatigue, depressive symptoms, and proposed mediators in the same trial and explore relationships among daily and standard assessments.

  2. To qualitatively assess perceived efficacy of the YST and AC and acceptability of new methodology through semi-structured interviews in a subset of 20-40 participants.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I (YST): Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation.

GROUP II (AC): Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, and 8.

After completion of study, patients are followed up at 4 weeks.

Study Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
GI 1549: PROGRAMS TO SUPPORT YOU DURING CHEMOTHERAPY (PRO-YOU) A Randomized Controlled Pilot Study of Yoga Compared to an Attention Control in Patients Receiving Chemotherapy
Study Start Date :
Aug 1, 2016
Actual Primary Completion Date :
Jan 1, 2020
Actual Study Completion Date :
Jan 1, 2020

Arms and Interventions

ArmIntervention/Treatment
Experimental: Group I (Yoga Skills Training)

Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation.

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Questionnaire Administration
Ancillary studies

Other: Daily Survey Administration
Ancillary studies

Behavioral: Yoga Skills Training
The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home.
Other Names:
  • yoga
  • YST
  • Other: Actigraphy Assessment
    Ancillary studies
    Other Names:
  • Circadian Disruption - daily
  • Active Comparator: Group II (Attention Control)

    Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8.

    Other: Laboratory Biomarker Analysis
    Correlative studies

    Other: Questionnaire Administration
    Ancillary studies

    Other: Daily Survey Administration
    Ancillary studies

    Behavioral: Attention Control
    The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home.
    Other Names:
  • empathic attention control
  • supportive conversation
  • caring attention control
  • Other: Actigraphy Assessment
    Ancillary studies
    Other Names:
  • Circadian Disruption - daily
  • Outcome Measures

    Primary Outcome Measures

    1. Fatigue Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) [At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention]

      Fatigue will be assessed with the 7-item measure of Fatigue from the PROMIS-cancer specifically designed for use in cancer patients. These tests will be evaluated using mixed-effects (or multilevel) generalized linear modeling procedures. Score range 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. Total scores can range from 24 to 86, with higher scores indicating greater fatigue.

    Secondary Outcome Measures

    1. Circadian Disruption (Daily) [At 0-2 weeks after start of intervention]

      Circadian disruption will be assessed with actigraphy. Circadian disruption is defined as a ratio of nighttime activity to daytime activity with higher scores indicating greater circadian disruptions. Summaries of the proportion and frequency of missing daily assessments will inform the feasibility of collecting this type of data.

    2. Circadian Disruption (Daily) [At 8-10 weeks after start of intervention]

      Circadian disruption will be assessed with actigraphy. Circadian disruption is defined as a ratio of nighttime activity to daytime activity with higher scores indicating greater circadian disruptions. Summaries of the proportion and frequency of missing daily assessments will inform the feasibility of collecting this type of data.

    3. Circadian Disruption (Recalled) [At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention]

      Circadian disruption will be assessed with measures of activity and rest. Activity will be measured using the 3-item Godin's leisure score index (LSI), previously used with colorectal cancer patients during chemotherapy. Rest will be assessed with the 8-item PROMIS sleep disturbance short-form. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.

    4. Depressive Symptoms Assessed by PROMIS [At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention]

      Will be assessed with the standardized 10-item PROMIS-cancer depressive symptoms short-form. These tests will be evaluated using mixed-effects (or multilevel) generalized linear modeling procedures. Scoring scale range from 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. The higher the score the more depressive the symptoms. Scores on the short form range from 10 to 81.3; 10-55 is "normal", 55.1-59.9 "mild", 60-64.25 "moderate", and over 64.26 "severe" depression.

    5. Fatigue (Daily) [At 0-2 weeks and 8-10 weeks after start of intervention]

      Fatigue will be assessed with 3 items selected from the PROMIS measure of fatigue validated for use in daily diaries. Scoring scale range from 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. The higher the score the more fatigued the participants. Scores on the short form range from 0 to 81.3; 0-55 is "normal", 55.1-59.9 "mild", 60-64.25 "moderate", and over 64.26 "severe" fatigue.

    6. Depressive Symptoms (Daily) [At 0-2 weeks and 8-10 weeks after start of intervention]

      Depressive symptoms will be assessed with 3 items selected from the PROMIS measure of depression validated for use in daily diaries. Scoring scale range from 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. The higher the score the more depressive symptoms the participants exhibited. scores on the short form range from 0 to 81.3; 0-55 is "normal", 55.1-59.9 "mild", 60-64.25 "moderate", and over 64.26 "severe" depression.

    7. Interleukin 6 [IL-6] Measured Using High-sensitivity Quantikine Immunoassay Kits [At 2 weeks after start of intervention]

      Inflammatory cytokines (i.e., interleukin 6 [IL-6], soluble tumor necrosis factor receptor 1 [sTNF-R1], and tumor necrosis factor alpha [TNF-alpha]) that have been associated with fatigue during treatment for gastrointestinal cancer and influenced by yoga practice will be measured using high-sensitivity Quantikine immunoassay kits.

    8. Interleukin 6 [IL-6] Measured Using High-sensitivity Quantikine Immunoassay Kits [At 10 weeks after start of intervention]

      Inflammatory cytokines (i.e., interleukin 6 [IL-6], soluble tumor necrosis factor receptor 1 [sTNF-R1], and tumor necrosis factor alpha [TNF-alpha]) that have been associated with fatigue during treatment for gastrointestinal cancer and influenced by yoga practice will be measured using high-sensitivity Quantikine immunoassay kits. ). All samples will be assayed in duplicate and the average of the two measures will be used for data analyses.

    9. Soluble Tumor Necrosis Factor Receptor 1 [sTNF-R1] Measured Using High-sensitivity Quantikine Immunoassay Kits [At 2 weeks after start of intervention]

      Inflammatory cytokines (i.e., interleukin 6 [IL-6], soluble tumor necrosis factor receptor 1 [sTNF-R1], and tumor necrosis factor alpha [TNF-alpha]) that have been associated with fatigue during treatment for gastrointestinal cancer and influenced by yoga practice will be measured using high-sensitivity Quantikine immunoassay kits.

    10. Soluble Tumor Necrosis Factor Receptor 1 [sTNF-R1] Measured Using High-sensitivity Quantikine Immunoassay Kits [At 10 weeks after start of intervention]

      Inflammatory cytokines (i.e., interleukin 6 [IL-6], soluble tumor necrosis factor receptor 1 [sTNF-R1], and tumor necrosis factor alpha [TNF-alpha]) that have been associated with fatigue during treatment for gastrointestinal cancer and influenced by yoga practice will be measured using high-sensitivity Quantikine immunoassay kits. All samples will be assayed in duplicate and the average of the two measures will be used for data analyses.

    11. Tumor Necrosis Factor Alpha [TNF-alpha] Measured Using High-sensitivity Quantikine Immunoassay Kits [At 2 weeks after start of intervention]

      Inflammatory cytokines (i.e., interleukin 6 [IL-6], soluble tumor necrosis factor receptor 1 [sTNF-R1], and tumor necrosis factor alpha [TNF-alpha]) that have been associated with fatigue during treatment for gastrointestinal cancer and influenced by yoga practice will be measured using high-sensitivity Quantikine immunoassay kits.

    12. Tumor Necrosis Factor Alpha [TNF-alpha] Measured Using High-sensitivity Quantikine Immunoassay Kits [At 10 weeks after start of intervention]

      Inflammatory cytokines (i.e., interleukin 6 [IL-6], soluble tumor necrosis factor receptor 1 [sTNF-R1], and tumor necrosis factor alpha [TNF-alpha]) that have been associated with fatigue during treatment for gastrointestinal cancer and influenced by yoga practice will be measured using high-sensitivity Quantikine immunoassay kits. All samples will be assayed in duplicate and the average of the two measures will be used for data analyses.

    13. Psychological Stress Assessed by the Perceived Stress Scale (PSS) [At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention]

      Psychological stress will be assessed by the 10-item PSS. The PSS has 2 factors (stress and counter stress). Scoring scale range from 0 - never, 1 - almost never, 2 - sometimes, 3 - fairly often and 4 - very often. Score range is 0-40. A higher score represents more of the concept being measured.

    14. Psychological Stress Assessed by the PSS (Daily) [At 0-2 weeks and 8-10 weeks after start of intervention]

      Psychological stress will be assessed daily with two items from the 4-item PSS that would be on the same factor to optimize internal consistency. Scoring scale range from 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. A mean of the participants scores was taken.

    15. Regulation of Psychological Stress Assessed by the Positive and Negative Affect Schedule-Expanded Form (Daily) [At 0-2 weeks and 8-10 weeks after start of intervention]

      Regulation of psychological stress will be assessed daily with the 3-item serenity subscale (calm, relaxed, at ease) from the Positive and Negative Affect Schedule-Expanded Form. Each item is rated on a five-point Likert Scale, ranging from 1 = Very Slightly or Not at all to 5 = Extremely. Positive Affect Score: Scores can range from 10 - 50, with higher scores representing higher levels of positive affect and lower scores representing lower levels of negative affect.

    16. Regulation of Psychological Stress Assessed Using the Cancer Behavior Inventory [At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention]

      Regulation of psychological stress will be determined by ratings on four of the seven factors of the Cancer Behavior Inventory, which assess self-efficacy for stress management, coping with treatment-related side-effects, accepting cancer/maintaining positive attitude, and affective regulation. Scale ranged from 1-9 (1 - 3 not at all confident; 4-6 moderately confident and 7-9 totally confident). 4 of the 7 items from the Cancer Behavior Inventory (V2.0) were used with each item's score ranges from 0-50 with higher scores indicating more confidence in the item.

    17. Minutes of Home Practice Completed [Up 10 weeks after start of intervention]

      Participants will keep daily paper logs of their home practice. In addition, one item will ask via the daily automated survey how many minutes participants practiced the intervention that day for two weeks after completion of the intervention.

    18. Percent of Planned In Person Intervention Sessions Attended [At baseline, 2 weeks, 8 weeks, 10 weeks and 14 weeks after start of intervention]

      Percent of all assessments completed and timeliness of completion will be tracked.

    19. Number of Participants With Successful Qualitative Data Collection [At 14 weeks after start of intervention]

      Qualitative feedback will be assessed with a semi-structured interview conducted after completion of all assessments. Qualitative information gained will enrich quantitative results and inform the protocol of a larger trial.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Scheduled to receive first-line Fluorouracil (5FU)-based intravenous chemotherapy treatment for a gastrointestinal cancer (stages II-IV)

    • Have an Eastern Cooperative Oncology Group performance status of =< 1

    • Ability to understand and the willingness to sign and informed consent document in English

    Exclusion Criteria:
    • Has a self-reported history of diagnosed uncontrolled obstructive sleep apnea (ok if using CPAP), sleep-related seizures, sleep walking more than one time per week, restless leg syndrome, or a job with night shifts

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Wake Forest Baptist Comprehensive Cancer CenterWinston-SalemNorth CarolinaUnited States27157
    2Vanderbilt University/Ingram Cancer CenterNashvilleTennesseeUnited States37232

    Sponsors and Collaborators

    • Wake Forest University Health Sciences
    • National Cancer Institute (NCI)
    • National Center for Complementary and Integrative Health (NCCIH)

    Investigators

    • Principal Investigator: Stephanie Sohl, MD, Vanderbilt University/Ingram Cancer Center

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Wake Forest University Health Sciences
    ClinicalTrials.gov Identifier:
    NCT02489422
    Other Study ID Numbers:
    • IRB00038321
    • NCI-2015-01042
    • CCCWFU 01716
    • K01AT008219
    • P30CA068485
    First Posted:
    Jul 3, 2015
    Last Update Posted:
    Jan 10, 2022
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group TitleGroup I (Yoga Skills Training)Group II (Attention Control)
    Arm/Group DescriptionPatients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home. Actigraphy Assessment: Ancillary studiesPatients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home. Actigraphy Assessment: Ancillary studies
    Period Title: Overall Study
    STARTED2321
    COMPLETED2321
    NOT COMPLETED00

    Baseline Characteristics

    Arm/Group TitleGroup I (Yoga Skills Training)Group II (Attention Control)Total
    Arm/Group DescriptionPatients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home. Actigraphy Assessment: Ancillary studiesPatients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home. Actigraphy Assessment: Ancillary studiesTotal of all reporting groups
    Overall Participants232144
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    60.8
    (11.3)
    56.0
    (12.0)
    58.5
    (11.7)
    Sex: Female, Male (Count of Participants)
    Female
    13
    56.5%
    10
    47.6%
    23
    52.3%
    Male
    10
    43.5%
    11
    52.4%
    21
    47.7%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    1
    4.8%
    1
    2.3%
    Not Hispanic or Latino
    23
    100%
    20
    95.2%
    43
    97.7%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    3
    13%
    3
    14.3%
    6
    13.6%
    White
    20
    87%
    18
    85.7%
    38
    86.4%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    23
    100%
    21
    100%
    44
    100%

    Outcome Measures

    1. Primary Outcome
    TitleFatigue Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)
    DescriptionFatigue will be assessed with the 7-item measure of Fatigue from the PROMIS-cancer specifically designed for use in cancer patients. These tests will be evaluated using mixed-effects (or multilevel) generalized linear modeling procedures. Score range 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. Total scores can range from 24 to 86, with higher scores indicating greater fatigue.
    Time FrameAt baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleGroup I (Yoga Skills Training)Group II (Attention Control)
    Arm/Group DescriptionPatients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home. Actigraphy Assessment: Ancillary studiesPatients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home. Actigraphy Assessment: Ancillary studies
    Measure Participants2321
    Baseline
    53.1
    (1.8)
    56.8
    (1.9)
    8 weeks
    53.0
    (2.1)
    57.2
    (2.2)
    10 weeks
    51.1
    (2.2)
    57.2
    (2.4)
    14 weeks
    55.4
    (2.2)
    60.6
    (2.3)
    2. Secondary Outcome
    TitleCircadian Disruption (Daily)
    DescriptionCircadian disruption will be assessed with actigraphy. Circadian disruption is defined as a ratio of nighttime activity to daytime activity with higher scores indicating greater circadian disruptions. Summaries of the proportion and frequency of missing daily assessments will inform the feasibility of collecting this type of data.
    Time FrameAt 0-2 weeks after start of intervention

    Outcome Measure Data

    Analysis Population Description
    Numbers may vary based on number of participants that actually completed intervention materials
    Arm/Group TitleGroup I (Yoga Skills Training)Group II (Attention Control)
    Arm/Group DescriptionPatients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home. Actigraphy Assessment: Ancillary studiesPatients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home. Actigraphy Assessment: Ancillary studies
    Measure Participants2321
    Mean (Standard Error) [Days]
    11.5
    (2.8)
    9.9
    (3.4)
    3. Secondary Outcome
    TitleCircadian Disruption (Daily)
    DescriptionCircadian disruption will be assessed with actigraphy. Circadian disruption is defined as a ratio of nighttime activity to daytime activity with higher scores indicating greater circadian disruptions. Summaries of the proportion and frequency of missing daily assessments will inform the feasibility of collecting this type of data.
    Time FrameAt 8-10 weeks after start of intervention

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    4. Secondary Outcome
    TitleCircadian Disruption (Recalled)
    DescriptionCircadian disruption will be assessed with measures of activity and rest. Activity will be measured using the 3-item Godin's leisure score index (LSI), previously used with colorectal cancer patients during chemotherapy. Rest will be assessed with the 8-item PROMIS sleep disturbance short-form. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.
    Time FrameAt baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention

    Outcome Measure Data

    Analysis Population Description
    Numbers may vary based on number of participants that actually completed intervention materials
    Arm/Group TitleGroup I (Yoga Skills Training)Group II (Attention Control)
    Arm/Group DescriptionPatients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home. Actigraphy Assessment: Ancillary studiesPatients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home. Actigraphy Assessment: Ancillary studies
    Measure Participants2321
    Baseline leisure score index (LSI)
    19.6
    (5.4)
    19.9
    (3.6)
    8 weeks leisure score index (LSI)
    24.1
    (7.1)
    23.9
    (6.2)
    10 weeks leisure score index (LSI)
    19.8
    (4.4)
    29.7
    (12.0)
    14 weeks leisure score index
    24.1
    (5.5)
    38.1
    (12.8)
    5. Secondary Outcome
    TitleDepressive Symptoms Assessed by PROMIS
    DescriptionWill be assessed with the standardized 10-item PROMIS-cancer depressive symptoms short-form. These tests will be evaluated using mixed-effects (or multilevel) generalized linear modeling procedures. Scoring scale range from 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. The higher the score the more depressive the symptoms. Scores on the short form range from 10 to 81.3; 10-55 is "normal", 55.1-59.9 "mild", 60-64.25 "moderate", and over 64.26 "severe" depression.
    Time FrameAt baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleGroup I (Yoga Skills Training)Group II (Attention Control)
    Arm/Group DescriptionPatients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home. Actigraphy Assessment: Ancillary studiesPatients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home. Actigraphy Assessment: Ancillary studies
    Measure Participants2321
    Baseline
    49.9
    (1.9)
    51.4
    (2.0)
    8 weeks
    47.4
    (2.0)
    51.2
    (2.1)
    10 weeks
    46.6
    (2.3)
    50.5
    (2.5)
    14 weeks
    49.1
    (2.0)
    50.2
    (2.1)
    6. Secondary Outcome
    TitleFatigue (Daily)
    DescriptionFatigue will be assessed with 3 items selected from the PROMIS measure of fatigue validated for use in daily diaries. Scoring scale range from 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. The higher the score the more fatigued the participants. Scores on the short form range from 0 to 81.3; 0-55 is "normal", 55.1-59.9 "mild", 60-64.25 "moderate", and over 64.26 "severe" fatigue.
    Time FrameAt 0-2 weeks and 8-10 weeks after start of intervention

    Outcome Measure Data

    Analysis Population Description
    Numbers may vary based on number of participants that actually completed intervention materials
    Arm/Group TitleGroup I (Yoga Skills Training)Group II (Attention Control)
    Arm/Group DescriptionPatients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home. Actigraphy Assessment: Ancillary studiesPatients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home. Actigraphy Assessment: Ancillary studies
    Measure Participants2321
    0-2 weeks
    49.18
    (1.73)
    53.27
    (1.92)
    8-10 weeks
    51.00
    (2.06)
    53.29
    (2.38)
    7. Secondary Outcome
    TitleDepressive Symptoms (Daily)
    DescriptionDepressive symptoms will be assessed with 3 items selected from the PROMIS measure of depression validated for use in daily diaries. Scoring scale range from 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. The higher the score the more depressive symptoms the participants exhibited. scores on the short form range from 0 to 81.3; 0-55 is "normal", 55.1-59.9 "mild", 60-64.25 "moderate", and over 64.26 "severe" depression.
    Time FrameAt 0-2 weeks and 8-10 weeks after start of intervention

    Outcome Measure Data

    Analysis Population Description
    Numbers may vary based on number of participants that actually completed intervention materials
    Arm/Group TitleGroup I (Yoga Skills Training)Group II (Attention Control)
    Arm/Group DescriptionPatients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home. Actigraphy Assessment: Ancillary studiesPatients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home. Actigraphy Assessment: Ancillary studies
    Measure Participants2321
    0-2 weeks
    43.96
    (1.52)
    45.49
    (1.82)
    8-10 weeks
    44.38
    (2.36)
    44.58
    (1.89)
    8. Secondary Outcome
    TitleInterleukin 6 [IL-6] Measured Using High-sensitivity Quantikine Immunoassay Kits
    DescriptionInflammatory cytokines (i.e., interleukin 6 [IL-6], soluble tumor necrosis factor receptor 1 [sTNF-R1], and tumor necrosis factor alpha [TNF-alpha]) that have been associated with fatigue during treatment for gastrointestinal cancer and influenced by yoga practice will be measured using high-sensitivity Quantikine immunoassay kits.
    Time FrameAt 2 weeks after start of intervention

    Outcome Measure Data

    Analysis Population Description
    The number of participants represents the number that completed data to be analyzed for this particular outcome measure.
    Arm/Group TitleGroup I (Yoga Skills Training)Group II (Attention Control)
    Arm/Group DescriptionPatients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home. Actigraphy Assessment: Ancillary studiesPatients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home. Actigraphy Assessment: Ancillary studies
    Measure Participants1613
    Mean (95% Confidence Interval) [pg/ml]
    5.6
    4.6
    9. Secondary Outcome
    TitleInterleukin 6 [IL-6] Measured Using High-sensitivity Quantikine Immunoassay Kits
    DescriptionInflammatory cytokines (i.e., interleukin 6 [IL-6], soluble tumor necrosis factor receptor 1 [sTNF-R1], and tumor necrosis factor alpha [TNF-alpha]) that have been associated with fatigue during treatment for gastrointestinal cancer and influenced by yoga practice will be measured using high-sensitivity Quantikine immunoassay kits. ). All samples will be assayed in duplicate and the average of the two measures will be used for data analyses.
    Time FrameAt 10 weeks after start of intervention

    Outcome Measure Data

    Analysis Population Description
    The number of participants represents the number that completed data to be analyzed for this particular outcome measure.
    Arm/Group TitleGroup I (Yoga Skills Training)Group II (Attention Control)
    Arm/Group DescriptionPatients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home. Actigraphy Assessment: Ancillary studiesPatients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home. Actigraphy Assessment: Ancillary studies
    Measure Participants1613
    Mean (95% Confidence Interval) [pg/ml]
    0.58
    0.58
    10. Secondary Outcome
    TitleSoluble Tumor Necrosis Factor Receptor 1 [sTNF-R1] Measured Using High-sensitivity Quantikine Immunoassay Kits
    DescriptionInflammatory cytokines (i.e., interleukin 6 [IL-6], soluble tumor necrosis factor receptor 1 [sTNF-R1], and tumor necrosis factor alpha [TNF-alpha]) that have been associated with fatigue during treatment for gastrointestinal cancer and influenced by yoga practice will be measured using high-sensitivity Quantikine immunoassay kits.
    Time FrameAt 2 weeks after start of intervention

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleGroup I (Yoga Skills Training)Group II (Attention Control)
    Arm/Group DescriptionPatients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home. Actigraphy Assessment: Ancillary studiesPatients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home. Actigraphy Assessment: Ancillary studies
    Measure Participants1613
    Mean (95% Confidence Interval) [pg/ml]
    1633.8
    1727.5
    11. Secondary Outcome
    TitleSoluble Tumor Necrosis Factor Receptor 1 [sTNF-R1] Measured Using High-sensitivity Quantikine Immunoassay Kits
    DescriptionInflammatory cytokines (i.e., interleukin 6 [IL-6], soluble tumor necrosis factor receptor 1 [sTNF-R1], and tumor necrosis factor alpha [TNF-alpha]) that have been associated with fatigue during treatment for gastrointestinal cancer and influenced by yoga practice will be measured using high-sensitivity Quantikine immunoassay kits. All samples will be assayed in duplicate and the average of the two measures will be used for data analyses.
    Time FrameAt 10 weeks after start of intervention

    Outcome Measure Data

    Analysis Population Description
    The number of participants represents the number that completed data to be analyzed for this particular outcome measure.
    Arm/Group TitleGroup I (Yoga Skills Training)Group II (Attention Control)
    Arm/Group DescriptionPatients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home. Actigraphy Assessment: Ancillary studiesPatients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home. Actigraphy Assessment: Ancillary studies
    Measure Participants1613
    Mean (95% Confidence Interval) [pg/ml]
    0.87
    0.87
    12. Secondary Outcome
    TitleTumor Necrosis Factor Alpha [TNF-alpha] Measured Using High-sensitivity Quantikine Immunoassay Kits
    DescriptionInflammatory cytokines (i.e., interleukin 6 [IL-6], soluble tumor necrosis factor receptor 1 [sTNF-R1], and tumor necrosis factor alpha [TNF-alpha]) that have been associated with fatigue during treatment for gastrointestinal cancer and influenced by yoga practice will be measured using high-sensitivity Quantikine immunoassay kits.
    Time FrameAt 2 weeks after start of intervention

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleGroup I (Yoga Skills Training)Group II (Attention Control)
    Arm/Group DescriptionPatients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home. Actigraphy Assessment: Ancillary studiesPatients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home. Actigraphy Assessment: Ancillary studies
    Measure Participants1613
    Mean (95% Confidence Interval) [pg/ml]
    1.6
    1.7
    13. Secondary Outcome
    TitleTumor Necrosis Factor Alpha [TNF-alpha] Measured Using High-sensitivity Quantikine Immunoassay Kits
    DescriptionInflammatory cytokines (i.e., interleukin 6 [IL-6], soluble tumor necrosis factor receptor 1 [sTNF-R1], and tumor necrosis factor alpha [TNF-alpha]) that have been associated with fatigue during treatment for gastrointestinal cancer and influenced by yoga practice will be measured using high-sensitivity Quantikine immunoassay kits. All samples will be assayed in duplicate and the average of the two measures will be used for data analyses.
    Time FrameAt 10 weeks after start of intervention

    Outcome Measure Data

    Analysis Population Description
    Numbers may vary based on number of participants that actually completed intervention materials
    Arm/Group TitleGroup I (Yoga Skills Training)Group II (Attention Control)
    Arm/Group DescriptionPatients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home. Actigraphy Assessment: Ancillary studiesPatients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home. Actigraphy Assessment: Ancillary studies
    Measure Participants1613
    Mean (95% Confidence Interval) [pg/ml]
    1.01
    1.01
    14. Secondary Outcome
    TitlePsychological Stress Assessed by the Perceived Stress Scale (PSS)
    DescriptionPsychological stress will be assessed by the 10-item PSS. The PSS has 2 factors (stress and counter stress). Scoring scale range from 0 - never, 1 - almost never, 2 - sometimes, 3 - fairly often and 4 - very often. Score range is 0-40. A higher score represents more of the concept being measured.
    Time FrameAt baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleGroup I (Yoga Skills Training)Group II (Attention Control)
    Arm/Group DescriptionPatients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home. Actigraphy Assessment: Ancillary studiesPatients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home. Actigraphy Assessment: Ancillary studies
    Measure Participants2220
    Baseline, mean
    14.7
    (1.5)
    16.5
    (1.6)
    8 weeks
    11.4
    (1.8)
    13.7
    (1.9)
    10 weeks
    12.1
    (1.8)
    12.3
    (2.1)
    14 weeks
    12.5
    (1.8)
    13.6
    (1.9)
    15. Secondary Outcome
    TitlePsychological Stress Assessed by the PSS (Daily)
    DescriptionPsychological stress will be assessed daily with two items from the 4-item PSS that would be on the same factor to optimize internal consistency. Scoring scale range from 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. A mean of the participants scores was taken.
    Time FrameAt 0-2 weeks and 8-10 weeks after start of intervention

    Outcome Measure Data

    Analysis Population Description
    Numbers may vary based on number of participants that actually completed intervention materials
    Arm/Group TitleGroup I (Yoga Skills Training)Group II (Attention Control)
    Arm/Group DescriptionPatients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home. Actigraphy Assessment: Ancillary studiesPatients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home. Actigraphy Assessment: Ancillary studies
    Measure Participants2019
    0-2 weeks, mean
    1.34
    (0.36)
    1.58
    (0.42)
    8-10 weeks, mean
    1.69
    (0.55)
    1.78
    (0.45)
    16. Secondary Outcome
    TitleRegulation of Psychological Stress Assessed by the Positive and Negative Affect Schedule-Expanded Form (Daily)
    DescriptionRegulation of psychological stress will be assessed daily with the 3-item serenity subscale (calm, relaxed, at ease) from the Positive and Negative Affect Schedule-Expanded Form. Each item is rated on a five-point Likert Scale, ranging from 1 = Very Slightly or Not at all to 5 = Extremely. Positive Affect Score: Scores can range from 10 - 50, with higher scores representing higher levels of positive affect and lower scores representing lower levels of negative affect.
    Time FrameAt 0-2 weeks and 8-10 weeks after start of intervention

    Outcome Measure Data

    Analysis Population Description
    Numbers may vary based on number of participants that actually completed intervention materials
    Arm/Group TitleGroup I (Yoga Skills Training)Group II (Attention Control)
    Arm/Group DescriptionPatients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home. Actigraphy Assessment: Ancillary studiesPatients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home. Actigraphy Assessment: Ancillary studies
    Measure Participants2019
    0-2 weeks, mean
    10.51
    (0.55)
    9.59
    (0.66)
    8-10 weeks, mean
    10.53
    (0.74)
    10.36
    (0.84)
    17. Secondary Outcome
    TitleRegulation of Psychological Stress Assessed Using the Cancer Behavior Inventory
    DescriptionRegulation of psychological stress will be determined by ratings on four of the seven factors of the Cancer Behavior Inventory, which assess self-efficacy for stress management, coping with treatment-related side-effects, accepting cancer/maintaining positive attitude, and affective regulation. Scale ranged from 1-9 (1 - 3 not at all confident; 4-6 moderately confident and 7-9 totally confident). 4 of the 7 items from the Cancer Behavior Inventory (V2.0) were used with each item's score ranges from 0-50 with higher scores indicating more confidence in the item.
    Time FrameAt baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention

    Outcome Measure Data

    Analysis Population Description
    Numbers may vary based on number of participants that actually completed intervention materials
    Arm/Group TitleGroup I (Yoga Skills Training)Group II (Attention Control)
    Arm/Group DescriptionPatients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home. Actigraphy Assessment: Ancillary studiesPatients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home. Actigraphy Assessment: Ancillary studies
    Measure Participants2320
    Baseline - Stress management
    34.8
    (1.4)
    34.2
    (1.5)
    Baseline - Coping with treatment-related side effects
    33.1
    (1.8)
    30.6
    (1.8)
    Baseline - Accepting cancer/maintaining positive attitude
    37.8
    (1.3)
    39.3
    (0.9)
    Baseline - Affective regulation
    28.2
    (1.6)
    29.9
    (1.6)
    8 weeks - Stress management
    38.1
    (1.3)
    38.6
    (1.9)
    8 weeks - Coping with treatment-related side effects
    37.1
    (1.7)
    35.4
    (2.1)
    8 weeks - Accepting cancer/maintaining positive attitude
    40.4
    (1.2)
    38.9
    (1.6)
    8 weeks - Affective regulation
    29.8
    (2.1)
    31.8
    (2.1)
    10 weeks - Stress management
    38.2
    (1.1)
    38.5
    (1.6)
    10 weeks - Coping with treatment-related side effects
    36.8
    (1.6)
    37.5
    (2.3)
    10 weeks - Accepting cancer/maintaining positive attitude
    40.6
    (0.9)
    40.6
    (1.6)
    10 weeks - Affective regulation
    30.1
    (2.2)
    33.1
    (2.3)
    14 weeks - Stress management
    39.2
    (1.4)
    40.1
    (1.1)
    14 weeks - Coping with treatment-related side effects
    37.0
    (1.7)
    38.4
    (1.5)
    14 weeks - Accepting cancer/maintaining positive attitude
    40.0
    (1.2)
    41.1
    (1.0)
    14 weeks - Affective regulation
    32.3
    (2.1)
    34.0
    (1.9)
    18. Secondary Outcome
    TitleMinutes of Home Practice Completed
    DescriptionParticipants will keep daily paper logs of their home practice. In addition, one item will ask via the daily automated survey how many minutes participants practiced the intervention that day for two weeks after completion of the intervention.
    Time FrameUp 10 weeks after start of intervention

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleGroup I (Yoga Skills Training)Group II (Attention Control)
    Arm/Group DescriptionPatients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home. Actigraphy Assessment: Ancillary studiesPatients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home. Actigraphy Assessment: Ancillary studies
    Measure Participants1614
    Mean (Standard Error) [minutes]
    11.2
    (1.9)
    12.1
    (6.3)
    19. Secondary Outcome
    TitlePercent of Planned In Person Intervention Sessions Attended
    DescriptionPercent of all assessments completed and timeliness of completion will be tracked.
    Time FrameAt baseline, 2 weeks, 8 weeks, 10 weeks and 14 weeks after start of intervention

    Outcome Measure Data

    Analysis Population Description
    Four in-person interventions were performed per participant at weeks 2, 4, 6, and 8. A total of 92 interventions were available for completion for Group I. A total of 84 interventions were available for completion for Group II.
    Arm/Group TitleGroup I (Yoga Skills Training)Group II (Attention Control)
    Arm/Group DescriptionPatients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home. Actigraphy Assessment: Ancillary studiesPatients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home. Actigraphy Assessment: Ancillary studies
    Measure Participants2321
    Measure total of interventions available9284
    Number [total interventions actually completed]
    68
    72
    20. Secondary Outcome
    TitleNumber of Participants With Successful Qualitative Data Collection
    DescriptionQualitative feedback will be assessed with a semi-structured interview conducted after completion of all assessments. Qualitative information gained will enrich quantitative results and inform the protocol of a larger trial.
    Time FrameAt 14 weeks after start of intervention

    Outcome Measure Data

    Analysis Population Description
    As per the protocol, this outcome was intended to be combined after all other data collection is complete to solicit feedback as a group on the acceptability of data collection methods, the participants' experience with both the interventions (e.g., expected efficacy, what was useful), and barriers and facilitators to home practice. It was not intended to be separated but as overall feedback.
    Arm/Group TitleQualitative Interviews - Combined
    Arm/Group DescriptionQualitative feedback will be assessed with a semi-structured interview conducted after completion of all assessments.
    Measure Participants43
    Count of Participants [Participants]
    30
    130.4%

    Adverse Events

    Time FrameOver 8 weeks
    Adverse Event Reporting Description
    Arm/Group TitleGroup I (Yoga Skills Training)Group II (Attention Control)
    Arm/Group DescriptionPatients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home. Actigraphy Assessment: Ancillary studiesPatients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home. Actigraphy Assessment: Ancillary studies
    All Cause Mortality
    Group I (Yoga Skills Training)Group II (Attention Control)
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total2/23 (8.7%) 2/21 (9.5%)
    Serious Adverse Events
    Group I (Yoga Skills Training)Group II (Attention Control)
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total4/23 (17.4%) 3/21 (14.3%)
    Gastrointestinal disorders
    Bowel perforation1/23 (4.3%) 10/21 (0%) 0
    General disorders
    Death2/23 (8.7%) 22/21 (9.5%) 2
    Hepatobiliary disorders
    Bile duct stenosis0/23 (0%) 01/21 (4.8%) 1
    Renal and urinary disorders
    Acute kidney injury1/23 (4.3%) 10/21 (0%) 0
    Other (Not Including Serious) Adverse Events
    Group I (Yoga Skills Training)Group II (Attention Control)
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total1/23 (4.3%) 2/21 (9.5%)
    Gastrointestinal disorders
    Toothache1/23 (4.3%) 10/21 (0%) 0
    Musculoskeletal and connective tissue disorders
    Back pain0/23 (0%) 01/21 (4.8%) 1
    Psychiatric disorders
    Anxiety0/23 (0%) 01/21 (4.8%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/TitleStudy coordinator
    OrganizationWake Forest University Health Sciences
    Phone336-716-9055
    Emailmegreen@wakehealth.edu
    Responsible Party:
    Wake Forest University Health Sciences
    ClinicalTrials.gov Identifier:
    NCT02489422
    Other Study ID Numbers:
    • IRB00038321
    • NCI-2015-01042
    • CCCWFU 01716
    • K01AT008219
    • P30CA068485
    First Posted:
    Jul 3, 2015
    Last Update Posted:
    Jan 10, 2022
    Last Verified:
    Dec 1, 2021