Supportive Intervention Programs to Lessen Treatment Related Symptoms
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
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).
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Feasibility of implementing a YST among patients undergoing chemotherapy (participating rate, adherence, and retention)
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.
Up to 8 weeks
Stephanie J Sohl, PhD
United States: Institutional Review Board
|Wake Forest University Health Sciences||Winston-Salem, North Carolina 27157|