Programs to Support You During Chemotherapy (Pro-You)

Study Overview
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Brief Summary
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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.

Detailed Description
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PRIMARY OBJECTIVES: I. 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). II. 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. III. 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.

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

Conditions
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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

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (YST intervention)<br>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)<br>* Undergo YST<br>* Other names: yoga;Other: questionnaire administration<br>* Ancillary studies<br>Other: fatigue and depressive symptom assessment and management<br>* Ancillary studies<br>* Other names: fatigue and depressive assessment/management;Other: psychological stress assessment<br>* Ancillary studies<br>Other: laboratory biomarker analysis<br>* Correlative studies<br>|
| Active Comparator: Arm II (attention control)<br>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<br>* Ancillary studies<br>Other: fatigue and depressive symptom assessment and management<br>* Ancillary studies<br>* Other names: fatigue and depressive assessment/management;Other: psychological stress assessment<br>* Ancillary studies<br>Other: laboratory biomarker analysis<br>* Correlative studies<br>Other: Attention Control<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in fatigue (recalled) | 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. | at 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in depressive symptoms (recalled and daily) | 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. | Baseline up to 14 weeks | 
| Changes in daily fatigue | 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. | Baseline up to 14 weeks | 
| Changes in psychological stress (daily and recalled) as assessed by Perceived Stress Scale (PSS) | 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. | Baseline up to 14 weeks | 
| Regulation of psychological stress (daily and recalled) as assessed by Positive and Negative Affect Schedule-Expanded Form and Cancer Behavior Inventory | 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. | Up to 14 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Yoga, Mind-body therapies, Fatigue, Colorectal cancer, Depressive symptoms