NCT01590147

Supportive Intervention Programs Study

Supportive Intervention Programs to Lessen Treatment Related Symptoms

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Wake Forest University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Fatigue
• Nausea and Vomiting
• Pain
• Recurrent Colon Cancer
• Recurrent Rectal Cancer
• Stage I-IVB Colon Cancer
• Stage I-IVB Rectal Cancer

Interventions

Type	Name	Description
PROCEDURE	Yoga therapy	receive YST
OTHER	questionnaire administration	Ancillary studies
PROCEDURE	quality-of-life assessment	Ancillary studies
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	assessment of therapy complications	Ancillary studies
PROCEDURE	management of therapy complications	Receive YST or CE
OTHER	educational intervention	Receive CE

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2012-05-02
• Last updated: 2018-08-15

Locations

1 site across 1 country: United States