Programs to Support You During Chemotherapy (Pro-You)

NCT02148406 | Completed DMC

• 3 other identifiers: VICC GI 1416NCI-2014-00905P30CA068485
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Changes in depressive symptoms (recalled and daily)

  Baseline up to 14 weeks

• 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

Other Outcomes (6)

• Rates of home practice as assessed by daily paper logs

  Up to 10 weeks

• Rates of survey compliance

  Up to 10 weeks

• Rates of efficacy expectations as assessed by adapted items the Life Orientation Test-Revised

  Up to 10 weeks

Study Arms (2)

Arm I (YST intervention)

EXPERIMENTAL

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); Other: questionnaire administration; Other: fatigue and depressive symptom assessment and management; Other: psychological stress assessment; Other: laboratory biomarker analysis

Arm II (attention control)

ACTIVE COMPARATOR

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; Other: fatigue and depressive symptom assessment and management; Other: psychological stress assessment; Other: laboratory biomarker analysis; Other: Attention Control

Interventions

Yoga Skills Training (YST) BEHAVIORAL

Undergo YST

Also known as: yoga

Arm I (YST intervention)

questionnaire administration OTHER

Ancillary studies

Arm I (YST intervention); Arm II (attention control)

fatigue and depressive symptom assessment and management OTHER

Ancillary studies

Also known as: fatigue and depressive assessment/management

Arm I (YST intervention); Arm II (attention control)

psychological stress assessment OTHER

Ancillary studies

Arm I (YST intervention); Arm II (attention control)

laboratory biomarker analysis OTHER

Correlative studies

Arm I (YST intervention); Arm II (attention control)

Attention Control OTHER

Arm II (attention control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Related Links

• Vanderbilt-Ingram Cancer Center, Find a Clinical Trial

MeSH Terms

Conditions

Depression; Fatigue; Colonic Neoplasms; Rectal Neoplasms; Colorectal Neoplasms

Interventions

Yoga; Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Stephanie Sohl

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 22, 2014
• First Posted: May 28, 2014
• Study Start: August 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: June 23, 2015

Record last verified: 2015-06

Locations

US (1)