PRO-YOU: Programs To Support You During Chemotherapy
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
|
N/A |
Detailed Description
PRIMARY OBJECTIVES:
- 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:
-
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.
-
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
Arms and Interventions
Arm | Intervention/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:
Other: Actigraphy Assessment
Ancillary studies
Other Names:
|
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:
Other: Actigraphy Assessment
Ancillary studies
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
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
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Wake Forest Baptist Comprehensive Cancer Center | Winston-Salem | North Carolina | United States | 27157 |
2 | Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | United States | 37232 |
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.- IRB00038321
- NCI-2015-01042
- CCCWFU 01716
- K01AT008219
- P30CA068485
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Group I (Yoga Skills Training) | Group II (Attention Control) |
---|---|---|
Arm/Group Description | 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. 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 studies | Patients 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 | ||
STARTED | 23 | 21 |
COMPLETED | 23 | 21 |
NOT COMPLETED | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Group I (Yoga Skills Training) | Group II (Attention Control) | Total |
---|---|---|---|
Arm/Group Description | 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. 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 studies | Patients 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 | Total of all reporting groups |
Overall Participants | 23 | 21 | 44 |
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
Title | Fatigue Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) |
---|---|
Description | 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. |
Time Frame | At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Group I (Yoga Skills Training) | Group II (Attention Control) |
---|---|---|
Arm/Group Description | 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. 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 studies | Patients 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 Participants | 23 | 21 |
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)
|
Title | Circadian Disruption (Daily) |
---|---|
Description | 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. |
Time Frame | At 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 Title | Group I (Yoga Skills Training) | Group II (Attention Control) |
---|---|---|
Arm/Group Description | 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. 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 studies | Patients 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 Participants | 23 | 21 |
Mean (Standard Error) [Days] |
11.5
(2.8)
|
9.9
(3.4)
|
Title | Circadian Disruption (Daily) |
---|---|
Description | 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. |
Time Frame | At 8-10 weeks after start of intervention |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Circadian Disruption (Recalled) |
---|---|
Description | 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. |
Time Frame | At 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 Title | Group I (Yoga Skills Training) | Group II (Attention Control) |
---|---|---|
Arm/Group Description | 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. 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 studies | Patients 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 Participants | 23 | 21 |
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)
|
Title | Depressive Symptoms Assessed by PROMIS |
---|---|
Description | 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. |
Time Frame | At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Group I (Yoga Skills Training) | Group II (Attention Control) |
---|---|---|
Arm/Group Description | 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. 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 studies | Patients 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 Participants | 23 | 21 |
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)
|
Title | Fatigue (Daily) |
---|---|
Description | 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. |
Time Frame | At 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 Title | Group I (Yoga Skills Training) | Group II (Attention Control) |
---|---|---|
Arm/Group Description | 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. 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 studies | Patients 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 Participants | 23 | 21 |
0-2 weeks |
49.18
(1.73)
|
53.27
(1.92)
|
8-10 weeks |
51.00
(2.06)
|
53.29
(2.38)
|
Title | Depressive Symptoms (Daily) |
---|---|
Description | 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. |
Time Frame | At 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 Title | Group I (Yoga Skills Training) | Group II (Attention Control) |
---|---|---|
Arm/Group Description | 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. 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 studies | Patients 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 Participants | 23 | 21 |
0-2 weeks |
43.96
(1.52)
|
45.49
(1.82)
|
8-10 weeks |
44.38
(2.36)
|
44.58
(1.89)
|
Title | Interleukin 6 [IL-6] Measured Using High-sensitivity Quantikine Immunoassay Kits |
---|---|
Description | 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. |
Time Frame | At 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 Title | Group I (Yoga Skills Training) | Group II (Attention Control) |
---|---|---|
Arm/Group Description | 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. 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 studies | Patients 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 Participants | 16 | 13 |
Mean (95% Confidence Interval) [pg/ml] |
5.6
|
4.6
|
Title | Interleukin 6 [IL-6] Measured Using High-sensitivity Quantikine Immunoassay Kits |
---|---|
Description | 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. |
Time Frame | At 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 Title | Group I (Yoga Skills Training) | Group II (Attention Control) |
---|---|---|
Arm/Group Description | 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. 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 studies | Patients 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 Participants | 16 | 13 |
Mean (95% Confidence Interval) [pg/ml] |
0.58
|
0.58
|
Title | Soluble Tumor Necrosis Factor Receptor 1 [sTNF-R1] Measured Using High-sensitivity Quantikine Immunoassay Kits |
---|---|
Description | 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. |
Time Frame | At 2 weeks after start of intervention |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Group I (Yoga Skills Training) | Group II (Attention Control) |
---|---|---|
Arm/Group Description | 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. 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 studies | Patients 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 Participants | 16 | 13 |
Mean (95% Confidence Interval) [pg/ml] |
1633.8
|
1727.5
|
Title | Soluble Tumor Necrosis Factor Receptor 1 [sTNF-R1] Measured Using High-sensitivity Quantikine Immunoassay Kits |
---|---|
Description | 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. |
Time Frame | At 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 Title | Group I (Yoga Skills Training) | Group II (Attention Control) |
---|---|---|
Arm/Group Description | 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. 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 studies | Patients 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 Participants | 16 | 13 |
Mean (95% Confidence Interval) [pg/ml] |
0.87
|
0.87
|
Title | Tumor Necrosis Factor Alpha [TNF-alpha] Measured Using High-sensitivity Quantikine Immunoassay Kits |
---|---|
Description | 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. |
Time Frame | At 2 weeks after start of intervention |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Group I (Yoga Skills Training) | Group II (Attention Control) |
---|---|---|
Arm/Group Description | 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. 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 studies | Patients 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 Participants | 16 | 13 |
Mean (95% Confidence Interval) [pg/ml] |
1.6
|
1.7
|
Title | Tumor Necrosis Factor Alpha [TNF-alpha] Measured Using High-sensitivity Quantikine Immunoassay Kits |
---|---|
Description | 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. |
Time Frame | At 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 Title | Group I (Yoga Skills Training) | Group II (Attention Control) |
---|---|---|
Arm/Group Description | 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. 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 studies | Patients 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 Participants | 16 | 13 |
Mean (95% Confidence Interval) [pg/ml] |
1.01
|
1.01
|
Title | Psychological Stress Assessed by the Perceived Stress Scale (PSS) |
---|---|
Description | 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. |
Time Frame | At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Group I (Yoga Skills Training) | Group II (Attention Control) |
---|---|---|
Arm/Group Description | 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. 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 studies | Patients 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 Participants | 22 | 20 |
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)
|
Title | Psychological Stress Assessed by the PSS (Daily) |
---|---|
Description | 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. |
Time Frame | At 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 Title | Group I (Yoga Skills Training) | Group II (Attention Control) |
---|---|---|
Arm/Group Description | 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. 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 studies | Patients 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 Participants | 20 | 19 |
0-2 weeks, mean |
1.34
(0.36)
|
1.58
(0.42)
|
8-10 weeks, mean |
1.69
(0.55)
|
1.78
(0.45)
|
Title | Regulation of Psychological Stress Assessed by the Positive and Negative Affect Schedule-Expanded Form (Daily) |
---|---|
Description | 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. |
Time Frame | At 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 Title | Group I (Yoga Skills Training) | Group II (Attention Control) |
---|---|---|
Arm/Group Description | 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. 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 studies | Patients 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 Participants | 20 | 19 |
0-2 weeks, mean |
10.51
(0.55)
|
9.59
(0.66)
|
8-10 weeks, mean |
10.53
(0.74)
|
10.36
(0.84)
|
Title | Regulation of Psychological Stress Assessed Using the Cancer Behavior Inventory |
---|---|
Description | 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. |
Time Frame | At 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 Title | Group I (Yoga Skills Training) | Group II (Attention Control) |
---|---|---|
Arm/Group Description | 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. 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 studies | Patients 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 Participants | 23 | 20 |
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)
|
Title | Minutes of Home Practice Completed |
---|---|
Description | 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. |
Time Frame | Up 10 weeks after start of intervention |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Group I (Yoga Skills Training) | Group II (Attention Control) |
---|---|---|
Arm/Group Description | 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. 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 studies | Patients 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 Participants | 16 | 14 |
Mean (Standard Error) [minutes] |
11.2
(1.9)
|
12.1
(6.3)
|
Title | Percent of Planned In Person Intervention Sessions Attended |
---|---|
Description | Percent of all assessments completed and timeliness of completion will be tracked. |
Time Frame | At 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 Title | Group I (Yoga Skills Training) | Group II (Attention Control) |
---|---|---|
Arm/Group Description | 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. 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 studies | Patients 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 Participants | 23 | 21 |
Measure total of interventions available | 92 | 84 |
Number [total interventions actually completed] |
68
|
72
|
Title | Number of Participants With Successful Qualitative Data Collection |
---|---|
Description | 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. |
Time Frame | At 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 Title | Qualitative Interviews - Combined |
---|---|
Arm/Group Description | Qualitative feedback will be assessed with a semi-structured interview conducted after completion of all assessments. |
Measure Participants | 43 |
Count of Participants [Participants] |
30
130.4%
|
Adverse Events
Time Frame | Over 8 weeks | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Group I (Yoga Skills Training) | Group II (Attention Control) | ||
Arm/Group Description | 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. 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 studies | Patients 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 (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 2/23 (8.7%) | 2/21 (9.5%) | ||
Serious Adverse Events |
||||
Group I (Yoga Skills Training) | Group II (Attention Control) | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 4/23 (17.4%) | 3/21 (14.3%) | ||
Gastrointestinal disorders | ||||
Bowel perforation | 1/23 (4.3%) | 1 | 0/21 (0%) | 0 |
General disorders | ||||
Death | 2/23 (8.7%) | 2 | 2/21 (9.5%) | 2 |
Hepatobiliary disorders | ||||
Bile duct stenosis | 0/23 (0%) | 0 | 1/21 (4.8%) | 1 |
Renal and urinary disorders | ||||
Acute kidney injury | 1/23 (4.3%) | 1 | 0/21 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
Group I (Yoga Skills Training) | Group II (Attention Control) | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1/23 (4.3%) | 2/21 (9.5%) | ||
Gastrointestinal disorders | ||||
Toothache | 1/23 (4.3%) | 1 | 0/21 (0%) | 0 |
Musculoskeletal and connective tissue disorders | ||||
Back pain | 0/23 (0%) | 0 | 1/21 (4.8%) | 1 |
Psychiatric disorders | ||||
Anxiety | 0/23 (0%) | 0 | 1/21 (4.8%) | 1 |
Limitations/Caveats
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/Title | Study coordinator |
---|---|
Organization | Wake Forest University Health Sciences |
Phone | 336-716-9055 |
megreen@wakehealth.edu |
- IRB00038321
- NCI-2015-01042
- CCCWFU 01716
- K01AT008219
- P30CA068485