Relaxation for Women With Breast Cancer Undergoing Radiotherapy

This study is currently recruiting participants.
Verified April 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01202851
First received: September 14, 2010
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Other: Relaxation Program
Behavioral: Questionnaires
Other: Saliva Testing
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Biobehavioral Effects of Relaxation for Women With Breast Cancer Undergoing Radiotherapy

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Efficacy of Relaxation Program [ Time Frame: Prior to and during radiotherapy, through 6 week relaxation program and 12 months post radiotherapy ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 600
Study Start Date: February 2011
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Relaxation Group 1
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
3 times a week, 60 minute sessions for 6 weeks.
Behavioral: Questionnaires
Multiple questionnaires taken before, during and after radiotherapy/exercise intervention programs during course of study.
Other Name: survey
Other: Saliva Testing
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.
Experimental: Relaxation Group 2
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
3 times a week, 60 minute sessions for 6 weeks.
Behavioral: Questionnaires
Multiple questionnaires taken before, during and after radiotherapy/exercise intervention programs during course of study.
Other Name: survey
Other: Saliva Testing
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.
Waitlist Control Group (WLC)
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
Multiple questionnaires taken before, during and after radiotherapy/exercise intervention programs during course of study.
Other Name: survey
Other: Saliva Testing
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women with stage 0 - III breast cancer who will be undergoing daily adjuvant radiation for 4-6 weeks (patients only).
  2. 18 years of age or older (patient and spouse/partner).
  3. Able to read, write, and speak English or Spanish (patient and spouse/partner).

Exclusion Criteria:

  1. Patients who have any major psychiatric diagnoses (e.g., schizophrenia, bipolar disorder).
  2. Patients who have not undergone any surgical treatment for their cancer.
  3. Patients with extreme mobility issues (e.g., unable to get in and out of a chair unassisted).
  4. 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01202851

Contacts
Contact: Donna S. Capps, MA 713-792-1854 dscapps@mdanderson.org

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Donna S. Capps, MA    713-792-1854    dscapps@mdanderson.org   
Principal Investigator: Lorenzo Cohen, PHD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Lorenzo Cohen, PHD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01202851     History of Changes
Other Study ID Numbers: 2009-0976, NCI-2012-01895
Study First Received: September 14, 2010
Last Updated: April 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
radiotherapy
radiation therapy
stretching
relaxation
quality of life
QOL
fatigue
sleep disturbances
mental health
cost-effectiveness analysis
work productivity
home productivity
cortisol rhythmicity

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hydrocortisone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014