Supportive Intervention Programs Study (SIPS)

Wake Forest University (WFU)

Status: Completed

Conditions: Nausea and Vomiting; Recurrent Colon Cancer; Stage I-IVB Colon Cancer; Stage I-IVB Rectal Cancer; Recurrent Rectal Cancer; Fatigue; Pain

Treatments: Other: assessment of therapy complications; Procedure: quality-of-life assessment; Other: questionnaire administration; Other: educational intervention; Procedure: Yoga therapy; Other: laboratory biomarker analysis; Procedure: management of therapy complications

Study type: Interventional

Funder types: Other

Identifiers

NCT01590147

CCCWFU 98211 (Other Identifier)

NCI-2011-01093 (Registry Identifier)

IRB00016716

Details and patient eligibility

About

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.

Full 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).

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Arm 1 (YST)

Experimental group

Description:

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.

Treatment:

Procedure: Yoga therapy

Procedure: management of therapy complications

Other: laboratory biomarker analysis

Other: assessment of therapy complications

Procedure: quality-of-life assessment

Other: questionnaire administration

Arm 2 (CE)

Active Comparator group

Description:

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.

Treatment:

Procedure: management of therapy complications

Other: laboratory biomarker analysis

Other: assessment of therapy complications

Procedure: quality-of-life assessment

Other: questionnaire administration

Other: educational intervention