Programs to Support You During Chemotherapy (Pro-You): Feasibility
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Changes in fatigue (recalled)
Study Overview
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Yoga Skills Training (YST) (Behavioral)
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.
Intervention: questionnaire administration (Other)
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.
Intervention: fatigue and depressive symptom assessment and management (Other)
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.
Intervention: psychological stress assessment (Other)
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.
Intervention: laboratory biomarker analysis (Other)
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.
Intervention: questionnaire administration (Other)
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.
Intervention: fatigue and depressive symptom assessment and management (Other)
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.
Intervention: psychological stress assessment (Other)
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.
Intervention: laboratory biomarker analysis (Other)
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.
Intervention: Attention Control (Other)
Outcomes
Primary Outcomes
Changes in fatigue (recalled)
Time Frame: 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 Outcomes
- Changes in daily fatigue(Baseline up to 14 weeks)
- Changes in psychological stress (daily and recalled) as assessed by Perceived Stress Scale (PSS)(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(Up to 14 weeks)
- Changes in depressive symptoms (recalled and daily)(Baseline up to 14 weeks)
Investigators
Stephanie Sohl
Principal Investigator
Vanderbilt-Ingram Cancer Center