Relaxation for Women With Breast Cancer Undergoing Radiotherapy

NCT01202851 | Active Not Recruiting Phase 3

• 3 other identifiers: 2009-0976NCI-2012-018952T32CA009666-21
• Study Type: interventional
• Target: 681
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this behavioral research study is to compare two different forms of relaxation programs that will include stretching and relaxation techniques, in order to learn if and how well they may help to improve physical and emotional well-being. This will be tested in patients with breast cancer who are receiving radiation therapy. For comparison purposes, there will also be a group of participants that does not take part in the relaxation programs. This is an investigational study. The relaxation programs are being compared for research purposes only. An "assessment" is any time you complete a set of scheduled activities for this study, such as tests and questionnaires. Up to 700 patients will take part in this study. All will be enrolled at MD Anderson.

Conditions

Breast Cancer

Keywords

radiotherapy; radiation therapy; stretching; relaxation; quality of life; QOL; fatigue; sleep disturbances; mental health; cost-effectiveness analysis; work productivity; home productivity; cortisol rhythmicity

Outcome Measures

Primary Outcomes (1)

• Efficacy of Relaxation Program

  Effectiveness of 6-week relaxation intervention evaluated by physical component scale scores during and after treatment, defined as Medical Outcomes Study 36-item short-form survey (SF-36).

  Prior to and during radiotherapy, through 6 week relaxation program and 12 months post radiotherapy

Study Arms (3)

Relaxation Group 1

EXPERIMENTAL

Simple stretching exercises, specific breathing skills, and guided relaxation for 3 sessions, 3 times a week for 6 weeks. Each session should last about 60 minutes. Multiple questionnaires taken before, during and after radiotherapy/exercise intervention programs during course of study. 4 saliva samples per day for cortisol testing for 3 days before radiation therapy begins, for 3 days in the last week of radiation therapy, for 3 days in a row 3 months after radiation therapy ended, for 3 days in a row, for 6 months after radiation therapy ended, and for 12 months after radiation therapy ended.

Other: Relaxation Program; Behavioral: Questionnaires; Other: Saliva Testing

Relaxation Group 2

EXPERIMENTAL

Simple stretching exercises, specific breathing skills, and guided relaxation for 3 sessions, 3 times a week for 6 weeks. Each session should last about 60 minutes. Multiple questionnaires taken before, during and after radiotherapy/exercise intervention programs during course of study. 4 saliva samples per day for cortisol testing for 3 days before radiation therapy begins, for 3 days in the last week of radiation therapy, for 3 days in a row 3 months after radiation therapy ended, for 3 days in a row, for 6 months after radiation therapy ended, and for 12 months after radiation therapy ended.

Other: Relaxation Program; Behavioral: Questionnaires; Other: Saliva Testing

Waitlist Control Group (WLC)

OTHER

Participants in this group given the option to take part in one of the two forms of relaxation (off study) after they finish their last questionnaire packet. 4 saliva samples per day for cortisol testing for 3 days before radiation therapy begins, for 3 days in the last week of radiation therapy, for 3 days in a row 3 months after radiation therapy ended, for 3 days in a row, for 6 months after radiation therapy ended, and for 12 months after radiation therapy ended.

Behavioral: Questionnaires; Other: Saliva Testing

Interventions

Relaxation Program OTHER

3 times a week, 60 minute sessions for 6 weeks.

Relaxation Group 1; Relaxation Group 2

Questionnaires BEHAVIORAL

Multiple questionnaires taken before, during and after radiotherapy/exercise intervention programs during course of study.

Also known as: survey

Relaxation Group 1; Relaxation Group 2; Waitlist Control Group (WLC)

Saliva Testing OTHER

4 saliva samples per day for cortisol testing for 3 days before radiation therapy begins, for 3 days in the last week of radiation therapy, for 3 days in a row 3 months after radiation therapy ended, for 3 days in a row, for 6 months after radiation therapy ended, and for 12 months after radiation therapy ended.

Relaxation Group 1; Relaxation Group 2; Waitlist Control Group (WLC)

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 who will be undergoing daily adjuvant radiation for 4-6 weeks (patients only).
• years of age or older (patient and spouse/partner).
• Able to read, write, and speak English or Spanish (patient and spouse/partner).

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• National Institutes of Health (NIH): 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; Fatigue; Parasomnias; Psychological Well-Being

Interventions

Relaxation Therapy; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; 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: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2010
• First Posted: September 16, 2010
• Study Start: February 10, 2011
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 28, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

US (1)