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Supportive Intervention Programs to Lessen Treatment Related Symptoms

18 Years
Open (Enrolling)
Fatigue, Nausea and Vomiting, Pain, Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage I-IVB Colon Cancer, Stage I-IVB Rectal Cancer

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Trial Information

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
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).

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Feasibility of implementing a YST among patients undergoing chemotherapy (participating rate, adherence, and retention)

Outcome Description:

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.

Outcome Time Frame:

Up to 8 weeks

Safety Issue:


Principal Investigator

Stephanie J Sohl, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Wake Forest


United States: Institutional Review Board

Study ID:

CCCWFU 98211



Start Date:

June 2011

Completion Date:

Related Keywords:

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



Wake Forest University Health Sciences Winston-Salem, North Carolina  27157