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Depressive Symptoms | Programs to Support You During Chemotherapy (Pro-You)

Depressive Symptoms research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

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

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral:Yoga Skills Training (YST)Undergo YST

Other:questionnaire administrationAncillary studies

Other:fatigue and depressive symptom assessment and managementAncillary studies

Other:psychological stress assessmentAncillary studies

Other:laboratory biomarker analysisCorrelative studies

Other:Attention Control

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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.

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.

Study Status

Completed

Start Date: August 2014

Completed Date: April 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Changes in fatigue (recalled)

Secondary Outcome: Changes in depressive symptoms (recalled and daily)

Study sponsors, principal investigator, and references

Principal Investigator: Stephanie Sohl

Lead Sponsor: Vanderbilt-Ingram Cancer Center

Collaborator: National Cancer Institute (NCI)

More information:https://clinicaltrials.gov/show/NCT02148406

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