Clinical trial NCT01590147: Supportive Intervention Programs Study
Official title: Supportive Intervention Programs to Lessen Treatment Related Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Nausea and Vomiting
Pain
Recurrent Colon Cancer
Recurrent Rectal Cancer
Stage I-IVB Colon Cancer
Stage I-IVB Rectal Cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2012-05-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Feasibility of implementing a YST among patients undergoing chemotherapy (participating rate, adherence, and retention)
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: Preliminary efficacy of YST, in terms of reducing fatigue
timeFrame: At week 8
measure: Treatment related symptoms and QOL
timeFrame: At week 8
measure: Mediating variables (self efficacy, response expectancies, inflammatory biomarkers) intervention effect on fatigue, treatment-related symptoms, and QOL
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest
name: Stephanie J Sohl, PhD
role: PRINCIPAL_INVESTIGATOR
References: