Yoga or Stretching and Relaxation in Improving Physical Function in Patients with Stage 0-III Breast Cancer Undergoing Radiation Therapy

Status: Closed to Accrual

Description

This randomized phase III trial studies yoga or stretching and relaxation in improving physical function in patients with stage 0-III breast cancer undergoing radiation therapy. Yoga therapy may help improve quality of life in breast cancer patients undergoing radiotherapy. It is not yet known if yoga is more effective than stretching and relaxation in improving physical function.

Eligibility Criteria

Inclusion Criteria

  • Women with stage 0-III breast cancer who will be undergoing daily adjuvant radiation for 4-6 weeks (patients only)
  • Able to read, write, and speak English or Spanish (patient and spouse/partner)

Exclusion Criteria

  • Patients who have any major psychiatric diagnoses (e.g., schizophrenia, bipolar disorder)
  • Patients who have not undergone any surgical treatment for their cancer
  • Patients with extreme mobility issues (e.g., unable to get in and out of a chair unassisted)
  • Patients who have practiced yoga or taken yoga classes in the year prior to study enrollment or who are currently engaged in a regular mind-body practice

Locations & Contacts

See trial information on ClinicalTrials.gov for a list of participating sites.

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. Examine the efficacy of a yoga program incorporated into the treatment schedule for women with breast cancer undergoing radiotherapy.

II. Determine the effects of the yoga program on other aspects of adjustment.

III. Identify some of the processes underlying the efficacy of the intervention.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

ARM I: Patients attend 60-minute yoga classes 3 times per week for 6 weeks or 4-5 times per week for 4 weeks, concurrently with radiation therapy. Patients are then further randomized to maintenance comprising telephone contact once per month with booster sessions every 3 months after completion of therapy, or usual care, with no contact after completion of therapy.

ARM II: Patients attend 60-minute stretching and relaxation classes 3 times per week for 6 weeks or 4-5 times per week for 4 weeks, concurrently with radiation therapy. Patients are then further randomized to maintenance or usual care as in Arm I.

ARM III: Patients complete quality of life assessments.

After completion of study treatment, patients in the maintenance arms are followed up monthly, and patients in usual contact arms and in arm III are followed up at 3, 6, and 12 months.

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Supportive care

Lead Organization

Lead Organization
M D Anderson Cancer Center

Principal Investigator
Lorenzo Cohen

Trial IDs

Primary ID 2009-0976
Secondary IDs NCI-2012-01895
Clinicaltrials.gov ID NCT01202851