Clinical trial NCT02148406: Programs to Support You During Chemotherapy (Pro-You)
Official title: Programs to Support You During Chemotherapy (Pro-You): Feasibility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Keywords: Yoga
Mind-body therapies
Fatigue
Colorectal cancer
Depressive symptoms
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-05-28
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in fatigue (recalled)
timeFrame: at 10 weeks
Secondary outcomes:
measure: Changes in depressive symptoms (recalled and daily)
timeFrame: Baseline up to 14 weeks
measure: Changes in daily fatigue
timeFrame: Baseline up to 14 weeks
measure: Changes in psychological stress (daily and recalled) as assessed by Perceived Stress Scale (PSS)
timeFrame: Baseline up to 14 weeks
measure: Regulation of psychological stress (daily and recalled) as assessed by Positive and Negative Affect Schedule-Expanded Form and Cancer Behavior Inventory
timeFrame: Up to 14 weeks
Other outcomes:
measure: Rates of home practice as assessed by daily paper logs
timeFrame: Up to 10 weeks
measure: Rates of survey compliance
timeFrame: Up to 10 weeks
measure: Rates of efficacy expectations as assessed by adapted items the Life Orientation Test-Revised
timeFrame: Up to 10 weeks
measure: Rates of satisfaction
timeFrame: Up to 14 weeks
measure: Reliability of the responses
timeFrame: Up to 14 weeks
measure: Changes in circadian disruption (daily and recalled) as assessed by actigraphy and the Godin's Leisure Score Index
timeFrame: Baseline up to 14 weeks
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Stephanie Sohl
role: PRINCIPAL_INVESTIGATOR
References: