Trials / Completed

CompletedNCT02148406

Programs to Support You During Chemotherapy (Pro-You)

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

Status: Completed
Phase: N/A
Study type: Interventional
Enrollment: 3 (actual)

Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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. 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.

Conditions

Interventions

Type	Name	Description
BEHAVIORAL	Yoga Skills Training (YST)	Undergo YST
OTHER	questionnaire administration	Ancillary studies
OTHER	fatigue and depressive symptom assessment and management	Ancillary studies
OTHER	psychological stress assessment	Ancillary studies
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	Attention Control

Timeline

Start date: 2014-08-01
Primary completion: 2015-04-01
Completion: 2015-04-01
First posted: 2014-05-28
Last updated: 2015-06-23

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02148406. Inclusion in this directory is not an endorsement.