Programs to Support You During Chemotherapy (Pro-You)

Sponsor

Vanderbilt-Ingram Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT02148406

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arms

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This randomized pilot clinical trial studies Yoga Skills Training or attention control in reducing fatigue and depressive symptoms during chemotherapy in patients with stage II-IV colorectal cancer. Yoga Skills Training consists of meditation, movement and breathing practices that aim to promote mindfulness and relaxation. Attention control consists of conversations with a caring professional with a recommendation to complete daily home diaries. It is not yet known whether Yoga Skills Training is better than attention control at reducing fatigue and depressive symptoms in patients undergoing chemotherapy.The purpose of this initial feasibility study is to refine study procedures.

Condition or Disease	Intervention/Treatment	Phase
Depressive Symptoms Fatigue Psychosocial Effects of Cancer and Its Treatment Stage IIA Colon Cancer Stage IIA Rectal Cancer Stage IIB Colon Cancer Stage IIB Rectal Cancer Stage IIC Colon Cancer Stage IIC Rectal Cancer Stage IIIA Colon Cancer Stage IIIA Rectal Cancer Stage IIIB Colon Cancer Stage IIIB Rectal Cancer Stage IIIC Colon Cancer Stage IIIC Rectal Cancer Stage IVA Colon Cancer Stage IVA Rectal Cancer Stage IVB Colon Cancer Stage IVB Rectal Cancer	Behavioral: Yoga Skills Training (YST) Other: questionnaire administration Other: fatigue and depressive symptom assessment and management Other: psychological stress assessment Other: laboratory biomarker analysis Other: Attention Control	N/A

Detailed Description

PRIMARY OBJECTIVES:

To obtain preliminary data on the efficacy of the Yoga Skills Training (YST) for improving the targeted outcomes (primary: fatigue; secondary: depressive symptoms) as compared to the attention control (AC).
To explore potential mediators (psychological stress, circadian disruption, inflammation) and moderators (gender, dose of the YST, outcome expectancies) of the effects of the YST on targeted outcomes.
To qualitatively assess perceived efficacy of the interventions and acceptance of daily measurement through semi-structured interviews in a subset of participants.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (YST intervention): Patients undergo YST intervention comprising four individualized, 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation during outpatient chemotherapy sessions in weeks 2, 4, 6, and 8. Patients practice awareness - noticing the current state and establishing relaxed breathing for 5 minutes; movement - 7 minutes of gentle movements coordinated with the breath (such as raising and lowering the arms); breathing practice - 3 minutes of inhaling cool air as if through a straw; and meditation - 5 minutes of focus on letting go of physical and mental tension. Patients are given a handout describing the YST and audio recording with devices to play the recording to encourage patients to practice daily. Strategies to increase adherence to home practice will be implemented and patients will be asked to keep home practice logs.

ARM II (attention control): Patients attend four 30-minute in-person sessions with an interventionist in weeks 2, 4, 6, and 8. During these sessions, patients are encouraged to discuss their experiences while receiving chemotherapy and do not receive instruction of movement, meditation or breathing practices. Patients will also be asked to write brief diary entries daily at home.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

Programs to Support You During Chemotherapy (Pro-You): Feasibility

Study Start Date :

Aug 1, 2014

Actual Primary Completion Date :

Apr 1, 2015

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I (YST intervention) Patients undergo YST intervention comprising four individualized, 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation during outpatient chemotherapy sessions in weeks 2, 4, 6, and 8. Patients practice awareness - noticing the current state and establishing relaxed breathing for 5 minutes; movement - 7 minutes of gentle movements coordinated with the breath (such as raising and lowering the arms); breathing practice - 3 minutes of inhaling cool air as if through a straw; and meditation - 5 minutes of focus on letting go of physical and mental tension. Patients review a handout describing the YST and to encourage patients to practice daily with strategies to increase adherence to home practice. Patients also receive an audio recording of the YST and devices to play the recording and are asked to keep a home practice log.	Behavioral: Yoga Skills Training (YST) Undergo YST Other Names: yoga Other: questionnaire administration Ancillary studies Other: fatigue and depressive symptom assessment and management Ancillary studies Other Names: fatigue and depressive assessment/management Other: psychological stress assessment Ancillary studies Other: laboratory biomarker analysis Correlative studies
Active Comparator: Arm II (attention control) Patients attend four 30-minute sessions with an interventionist in weeks 2, 4, 6, and 8. During these sessions, patients are encouraged to discuss their experiences while receiving chemotherapy and do not receive instruction of movement, meditation or breathing practices. Patients will also be asked to write brief diary entries daily at home.	Other: questionnaire administration Ancillary studies Other: fatigue and depressive symptom assessment and management Ancillary studies Other Names: fatigue and depressive assessment/management Other: psychological stress assessment Ancillary studies Other: laboratory biomarker analysis Correlative studies Other: Attention Control

Arm

Intervention/Treatment

Experimental: Arm I (YST intervention)

Patients undergo YST intervention comprising four individualized, 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation during outpatient chemotherapy sessions in weeks 2, 4, 6, and 8. Patients practice awareness - noticing the current state and establishing relaxed breathing for 5 minutes; movement - 7 minutes of gentle movements coordinated with the breath (such as raising and lowering the arms); breathing practice - 3 minutes of inhaling cool air as if through a straw; and meditation - 5 minutes of focus on letting go of physical and mental tension. Patients review a handout describing the YST and to encourage patients to practice daily with strategies to increase adherence to home practice. Patients also receive an audio recording of the YST and devices to play the recording and are asked to keep a home practice log.

Behavioral: Yoga Skills Training (YST)

Undergo YST

Other Names:

yoga

Other: questionnaire administration

Ancillary studies

Other: fatigue and depressive symptom assessment and management

Ancillary studies

Other Names:

fatigue and depressive assessment/management

Other: psychological stress assessment

Ancillary studies

Other: laboratory biomarker analysis

Correlative studies

Active Comparator: Arm II (attention control)

Patients attend four 30-minute sessions with an interventionist in weeks 2, 4, 6, and 8. During these sessions, patients are encouraged to discuss their experiences while receiving chemotherapy and do not receive instruction of movement, meditation or breathing practices. Patients will also be asked to write brief diary entries daily at home.

Other: questionnaire administration

Ancillary studies

Other: fatigue and depressive symptom assessment and management

Ancillary studies

Other Names:

fatigue and depressive assessment/management

Other: psychological stress assessment

Ancillary studies

Other: laboratory biomarker analysis

Correlative studies

Other: Attention Control

Outcome Measures

Primary Outcome Measures

Changes in fatigue (recalled) [at 10 weeks]
Patient-Reported Outcomes Measurement Graphical and descriptive summaries of the patterns over time of these summary statistics for each of these groups will comprise a key initial phase of the analyses. Bootstrapping methods will be used to generate 95% confidence intervals for all sample descriptive statistics and effect estimates. Key statistical tests will involve between group differences in mean values and group differences in the patterns (i.e., slopes) of individual changes from respective baseline values. Evaluated using mixed-effects (or multilevel) generalized linear modeling procedures with robust variance estimation.

Secondary Outcome Measures

Changes in depressive symptoms (recalled and daily) [Baseline up to 14 weeks]
Graphical and descriptive summaries of the patterns over time of these summary statistics for each of these groups will comprise a key initial phase of the analyses. Bootstrapping methods will be used to generate 95% confidence intervals for all sample descriptive statistics and effect estimates. Key statistical tests will involve between group differences in mean values and group differences in the patterns (i.e., slopes) of individual changes from respective baseline values. Evaluated using mixed-effects (or multilevel) generalized linear modeling procedures with robust variance estimation.
Changes in daily fatigue [Baseline up to 14 weeks]
Patient-Reported Outcomes Measurement Graphical and descriptive summaries of the patterns over time of these summary statistics for each of these groups will comprise a key initial phase of the analyses. Bootstrapping methods will be used to generate 95% confidence intervals for all sample descriptive statistics and effect estimates. Key statistical tests will involve between group differences in mean values and group differences in the patterns (i.e., slopes) of individual changes from respective baseline values. Evaluated using mixed-effects (or multilevel) generalized linear modeling procedures with robust variance estimation.
Changes in psychological stress (daily and recalled) as assessed by Perceived Stress Scale (PSS) [Baseline up to 14 weeks]
Graphical and descriptive summaries of the patterns over time of these summary statistics for each of these groups will comprise a key initial phase of the analyses. Bootstrapping methods will be used to generate 95% confidence intervals for all sample descriptive statistics and effect estimates. Key statistical tests will involve between group differences in mean values and group differences in the patterns (i.e., slopes) of individual changes from respective baseline values. Evaluated using mixed-effects (or multilevel) generalized linear modeling procedures with robust variance estimation.
Regulation of psychological stress (daily and recalled) as assessed by Positive and Negative Affect Schedule-Expanded Form and Cancer Behavior Inventory [Up to 14 weeks]
Graphical and descriptive summaries of the patterns over time of these summary statistics for each of these groups will comprise a key initial phase of the analyses. Bootstrapping methods will be used to generate 95% confidence intervals for all sample descriptive statistics and effect estimates. Key statistical tests will involve between group differences in mean values and group differences in the patterns (i.e., slopes) of individual changes from respective baseline values. Evaluated using mixed-effects (or multilevel) generalized linear modeling procedures with robust variance estimation.

Other Outcome Measures

Rates of home practice as assessed by daily paper logs [Up to 10 weeks]
Mean levels of rates (%s) will be assessed
Rates of survey compliance [Up to 10 weeks]
Mean levels of rates (%s) will be assessed
Rates of efficacy expectations as assessed by adapted items the Life Orientation Test-Revised [Up to 10 weeks]
Mean levels of rates (%s) will be assessed
Rates of satisfaction [Up to 14 weeks]
Mean levels of rates (%s) will be assessed.
Reliability of the responses [Up to 14 weeks]
Changes in circadian disruption (daily and recalled) as assessed by actigraphy and the Godin's Leisure Score Index [Baseline up to 14 weeks]
Graphical and descriptive summaries of the patterns over time of these summary statistics for each of these groups will comprise a key initial phase of the analyses. Bootstrapping methods will be used to generate 95% confidence intervals for all sample descriptive statistics and effect estimates. Key statistical tests will involve between group differences in mean values and group differences in the patterns (i.e., slopes) of individual changes from respective baseline values. Evaluated using mixed-effects (or multilevel) generalized linear modeling procedures with robust variance estimation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Scheduled to receive first-line intravenous chemotherapy treatment for colorectal cancer (stages II-IV)
Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 1
Ability to understand and the willingness to sign an informed consent document written in English

Exclusion Criteria:

Regularly engaged (>= 3 days/week) in moderate physical activity of any kind (e.g., yoga) over the past 4 weeks
Has a self-reported history of diagnosed sleep disorders (e.g., obstructive sleep apnea, insomnia), comorbidities associated with poor sleep or fatigue (e.g., chronic fatigue syndrome), or a job with night shifts