Programs to Support You During Chemotherapy (Pro-You)

Vanderbilt University Medical Center

Status: Completed

Conditions: Stage IIB Colon Cancer; Stage IIIA Colon Cancer; Stage IVB Colon Cancer; Stage IVA Rectal Cancer; Stage IIC Colon Cancer; Stage IIA Colon Cancer; Stage IIIB Colon Cancer; Stage IIA Rectal Cancer; Fatigue; Stage IIIC Colon Cancer; Stage IIC Rectal Cancer; Stage IIB Rectal Cancer; Depressive Symptoms; Stage IIIB Rectal Cancer; Stage IVB Rectal Cancer; Stage IIIC Rectal Cancer; Psychosocial Effects of Cancer and Its Treatment; Stage IVA Colon Cancer; Stage IIIA Rectal Cancer

Treatments: Behavioral: Yoga Skills Training (YST); Other: questionnaire administration; Other: psychological stress assessment; Other: laboratory biomarker analysis; Other: Attention Control; Other: fatigue and depressive symptom assessment and management

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02148406

NCI-2014-00905 (Registry Identifier)

P30CA068485 (U.S. NIH Grant/Contract)

VICC GI 1416 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

3 participants in 2 patient groups

Arm I (YST intervention)

Experimental group

Description:

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.

Treatment:

Other: fatigue and depressive symptom assessment and management

Other: psychological stress assessment

Other: questionnaire administration

Other: laboratory biomarker analysis

Behavioral: Yoga Skills Training (YST)

Arm II (attention control)

Active Comparator group

Description:

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.

Treatment:

Other: fatigue and depressive symptom assessment and management

Other: psychological stress assessment

Other: questionnaire administration

Other: Attention Control

Other: laboratory biomarker analysis