Effects of Yoga in Breast Cancer Patients

NCT00508794 | Completed DMC

• 3 other identifiers: 2005-0522CA102385NCI-2010-00743
• Study Type: interventional
• Target: 191
• Locations: 1 country
• Sites: 1

Brief Summary

In this study researchers will examine the initial efficacy of implementing a yoga program for patients with breast cancer as an adjuvant to their radiotherapy. Patients with breast cancer who are undergoing radiotherapy will be randomly assigned to either a yoga group (YG), or a stretching (ST) control group, or a waitlist control (WL) group. Participants in YG and ST groups will attend three sessions each week throughout their 6-week radiotherapy schedule. The sessions will be coordinated with the treatment schedule and conducted adjacent to the treatment facility. Measures will be obtained prior to randomization, a brief assessment during the middle of radiation therapy, during the last week of radiation therapy, and 1, 3 and 6 months after the last radiation session. With the inclusion of two control groups in this randomized trial researchers will attempt to validate the benefits of yoga as an adjuvant to radiotherapy in patients with breast cancer wherein researchers will control for specific components of the yoga program and also examine some of the mechanisms that are necessary for the program to be effective. Our specific aims in the proposed study are to:

• Conduct an initial evaluation of whether participation in the yoga program improves patients' fatigue and sleep disturbances. Fatigue and sleep will be assessed with self-report measures and the use of actigraphy for a more objective measure of sleep quality.
• Secondary end points will include examining QOL, mental health and objective physiological outcomes (blood samples for immune measures, saliva samples for cortisol levels, and heart rate variability).
• Exploratory analyses will examine some plausible mediators of the yoga program including cognitive processing, spirituality, and finding meaning in the cancer experience.

Conditions

Breast Cancer

Keywords

Breast Cancer; Tibetan Yoga; Stretching Program; Yoga; Quality of Life; Questionnaire; Survey

Outcome Measures

Primary Outcomes (1)

• Fatigue and sleep assessed with self-report measures and actigraphy.

  Measures will be obtained prior to randomization, a brief assessment during the middle of radiation therapy, during the last week of radiation therapy, and 1, 3 and 6 months after the last radiation session.

Secondary Outcomes (2)

• To see if yoga will help to improve patients' quality of life (QOL) during treatment for cancer and during recovery from the effects of cancer treatment.

  4 Years

• To learn if a yoga program is effective in helping to decrease emotional distress and improve physiological functioning.

  4 Years

Study Arms (3)

Group 1 Yoga Program

EXPERIMENTAL

3 sessions of yoga each week for 6 weeks. Questionnaire evaluating treatment-related symptoms during the middle of radiotherapy.

Behavioral: Yoga Group; Other: Questionnaire

Group 2 Stretching Program

EXPERIMENTAL

3 sessions of stretching each week for 6 weeks. Questionnaire evaluating treatment-related symptoms during the middle of radiotherapy.

Behavioral: Stretching Control Group; Other: Questionnaire

Group 3 Waitlist Control Group

OTHER

Option of participating in the yoga or stretching program after the study has ended. Questionnaire evaluating treatment-related symptoms during the middle of radiotherapy.

Behavioral: Waitlist Control Group; Other: Questionnaire

Interventions

Yoga Group BEHAVIORAL

3 sessions of yoga each week for 6 weeks.

Group 1 Yoga Program

Stretching Control Group BEHAVIORAL

3 sessions of stretching each week for 6 weeks

Group 2 Stretching Program

Waitlist Control Group BEHAVIORAL

Option of participating in the yoga or stretching program after the study has ended.

Group 3 Waitlist Control Group

Questionnaire OTHER

Questionnaire evaluating treatment-related symptoms during the middle of radiotherapy.

Also known as: Survey

Group 1 Yoga Program; Group 2 Stretching Program; Group 3 Waitlist Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with Stage 0 - III breast cancer, undergoing daily adjuvant radiation for 6 weeks in the Department of Radiation Oncology at the M. D. Anderson
• The participants will need to be 18 years of age or older.
• Patients should be able to read, write, and speak English or Spanish.

You may not qualify if:

• Patients who have a documented diagnosis of a formal thought disorder (e.g., schizophrenia) will be excluded from the study.
• Patients with metastatic disease of the bone will be excluded to avoid any bone fractures that may result from yoga movements.
• Patients with active/non-canalized deep vein thrombosis will be excluded from the study.
• Patients who have not undergone any surgical treatment for their cancer will be excluded to ensure a more homogeneous sample.
• Patients with extreme mobility issues (e.g., unable to get in and out of a chair unassisted) will be excluded.
• Patients who have practiced yoga or taken yoga classes in the year prior to diagnosis will be excluded.
• Patients diagnosed with lymphedema at baseline will be excluded.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Lorenzo Cohen, PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2007
• First Posted: July 30, 2007
• Study Start: March 9, 2006
• Primary Completion: August 11, 2022
• Study Completion: August 11, 2022
• Last Updated: September 1, 2022

Record last verified: 2022-08

Locations

US (1)