Supportive Intervention Programs Study

Not Applicable

Completed

• Conditions: Stage I-IVB Colon Cancer; Stage I-IVB Rectal Cancer; Nausea and Vomiting; Recurrent Colon Cancer; Fatigue; Pain; Recurrent Rectal Cancer
• Interventions: Procedure: Yoga therapy; Other: questionnaire administration; Procedure: quality-of-life assessment; Other: laboratory biomarker analysis; Other: assessment of therapy complications; Procedure: management of therapy complications; Other: educational intervention

• Registration Number: NCT01590147
• Lead Sponsor: Wake Forest University

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2012-05-01
• Study First Submitted QC: 2012-05-01
• Study First Posted: 2012-05-02
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-13
• Last Update Posted: 2018-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Signed protocol specific informed consent
• Are diagnosed with colorectal cancer
• Recruited within 2 weeks of initiating chemotherapy (including reinitiating chemotherapy after a treatment holiday of greater than or equal to 4 weeks)
• Able to understand written and spoken English

Exclusion Criteria

• Under age 18 (children with colorectal cancer)
• Unable to read or understand English
• Vulnerable subjects (except those who are economically or educationally disadvantaged)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1 (YST)	questionnaire administration	Patients participate in three 15-minute YST sessions, comprising awareness meditation practice, movement practice, and breathing practice and relaxation. Patients also receive a CD recording of a 15-minute YST session and are instructed to practice the YST at home 4 times weekly.
Arm 1 (YST)	quality-of-life assessment	Patients participate in three 15-minute YST sessions, comprising awareness meditation practice, movement practice, and breathing practice and relaxation. Patients also receive a CD recording of a 15-minute YST session and are instructed to practice the YST at home 4 times weekly.
Arm 1 (YST)	laboratory biomarker analysis	Patients participate in three 15-minute YST sessions, comprising awareness meditation practice, movement practice, and breathing practice and relaxation. Patients also receive a CD recording of a 15-minute YST session and are instructed to practice the YST at home 4 times weekly.
Arm 1 (YST)	Yoga therapy	Patients participate in three 15-minute YST sessions, comprising awareness meditation practice, movement practice, and breathing practice and relaxation. Patients also receive a CD recording of a 15-minute YST session and are instructed to practice the YST at home 4 times weekly.
Arm 1 (YST)	management of therapy complications	Patients participate in three 15-minute YST sessions, comprising awareness meditation practice, movement practice, and breathing practice and relaxation. Patients also receive a CD recording of a 15-minute YST session and are instructed to practice the YST at home 4 times weekly.
Arm 2 (CE)	questionnaire administration	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.
Arm 2 (CE)	laboratory biomarker analysis	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.
Arm 2 (CE)	assessment of therapy complications	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.
Arm 2 (CE)	management of therapy complications	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.
Arm 1 (YST)	assessment of therapy complications	Patients participate in three 15-minute YST sessions, comprising awareness meditation practice, movement practice, and breathing practice and relaxation. Patients also receive a CD recording of a 15-minute YST session and are instructed to practice the YST at home 4 times weekly.
Arm 2 (CE)	quality-of-life assessment	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.
Arm 2 (CE)	educational intervention	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.

Primary Outcome Measures

Name	Time	Method
Feasibility of implementing a YST among patients undergoing chemotherapy (participating rate, adherence, and retention)	Up to 8 weeks	The proportion of participants who participated in all study sessions and those who completed all assessments will be computed and compared by demographic characteristics and intervention group. The investigators will model the relationship between adherence and baseline scores of the measures, as well as change in scores.

Secondary Outcome Measures

Name	Time	Method
Preliminary efficacy of YST, in terms of reducing fatigue	At week 8	Measured by the Functional Assessment of Cancer Therapy - Fatigue (FACT-F) subscale. Assessed using analysis of covariance (ANCOVA) models, accounting for possible confounding variables (e.g., medication use) from baseline to post intervention.
Treatment related symptoms and QOL	At week 8	The Functional Assessment of Cancer Therapy- Colorectal (FACT-C; 37) will be used to evaluate overall QOL (physical, social, emotional, and functional well-being) and colorectal cancer specific symptoms (e.g., cramps in stomach, control of bowels). Assessed using ANCOVA.
Mediating variables (self efficacy, response expectancies, inflammatory biomarkers) intervention effect on fatigue, treatment-related symptoms, and QOL	Up to 8 weeks	Assessed using a simultaneous model of the mediators and the intervention effect in the ANCOVA model.

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States