Loading clinical trials...
Loading clinical trials...
Supportive Intervention Programs to Lessen Treatment Related Symptoms
This randomized clinical trial studies the preliminary efficacy of a yoga skills training (YST) compared to counseling and education (CE) for reducing treatment-related symptoms in patients with colorectal cancer who are receiving chemotherapy. The YST may reduce fatigue, other treatment-related symptoms, and improve the quality of life (QOL) of patients with colorectal cancer. It is not yet known whether YST is more effective then CE in reducing these outcomes.
OBJECTIVES: I. To establish the feasibility of implementing a YST among patients undergoing chemotherapy. This includes the feasibility of implementing yoga in a treatment setting, and patient recruitment, adherence, and retention. II. To obtain preliminary data on the efficacy of a YST for reducing fatigue among patients undergoing chemotherapy. III. To obtain exploratory data on the impact of a YST on other treatment-related symptoms (e.g., pain, distress, nausea) and QOL. IV. To obtain exploratory data on the impact of a YST on potential psychological (self-efficacy for coping with cancer, response expectancies for symptoms) and physiological (interleukin \[IL\]-6 \[IL-6\], IL-1 Receptor Antagonist \[IL-1Ra\], tumor necrosis factor- alpha \[TNF-a\], soluble TNF receptor I \[sTNFRI\], C-reactive protein \[CRP\]) mediators that may explain the impact of the YST on fatigue. OUTLINE: Patients (n=20) are randomized to 1 of 2 treatment arms. ARM I: Patients participate in three 15-minute YST sessions, comprising awareness meditation practice, movement practice, and breathing practice and relaxation. Patients also receive a compact disc (CD) recording of a 15-minute YST session and are instructed to practice the YST at home 4 times weekly. ARM II: Patients participate in three 15-minute CE sessions, comprising empathic attention with an interventionist who allows patients to direct the flow of conversation and provides supportive comments according to standardized procedures. Patients also receive CDs with recorded information related to coping with colorectal cancer similar in length to the suggested practice time in Arm I. The interventions (Week 2, Week 4, Week 6) and assessments (Week 0, Week 4, Week 8) are implemented during visits for chemotherapy (every two weeks).
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Start Date
June 1, 2011
Primary Completion Date
July 1, 2013
Completion Date
July 1, 2013
Last Updated
August 15, 2018
15
ACTUAL participants
Yoga therapy
PROCEDURE
questionnaire administration
OTHER
quality-of-life assessment
PROCEDURE
laboratory biomarker analysis
OTHER
assessment of therapy complications
OTHER
management of therapy complications
PROCEDURE
educational intervention
OTHER
Lead Sponsor
Wake Forest University
NCT06346132
NCT07351968
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions