Trial Summary
What is the purpose of this trial?
This randomized clinical trial studies an integrative oncology (making changes in lifestyle and behavior) program in improving cancer-related outcomes in patients with stage II or III breast cancer undergoing radiation therapy. An integrative oncology program consisting of dietary recommendations, physical activity, stress management, social support, and control of environmental contaminants may modify cancer-related biological processes, influence long-term treatment results, and improve the quality of life of patients.
Eligibility Criteria
This trial is for English-speaking women with stage II or III breast cancer who are about to start a 4-6 week course of radiotherapy. They should be oriented and have a BMI of at least 24.45. Participants must also have poor lifestyle habits, like eating less than three servings of fruits and vegetables per day, exercising minimally, and rarely engaging in mind-body practices.Inclusion Criteria
I am a woman with stage II or III breast cancer scheduled for 4-6 weeks of radiotherapy.
Participants must be able to read, write, and speak English
You need to have a BMI of 24.45 or higher, which is a measure of your weight in relation to your height.
See 2 more
Exclusion Criteria
I have not had another primary cancer diagnosis in the last 5 years, except for non-melanoma skin cancers.
My diabetes is not well-managed according to my doctor.
I have difficulty hearing or communicating.
See 3 more
Treatment Details
Interventions
- Behavioral, Psychological or Informational Intervention (Behavioural Intervention)
- Best Practice (Behavioural Intervention)
- Cognitive Intervention (Behavioural Intervention)
- Computer-Assisted Intervention (Behavioural Intervention)
- Counseling (Behavioural Intervention)
- Exercise Intervention (Behavioural Intervention)
- Integrative Oncology Program (Behavioural Intervention)
- Laboratory Biomarker Analysis (Behavioural Intervention)
- Questionnaire Administration (Behavioural Intervention)
Trial OverviewThe study tests an integrative oncology program that includes diet changes, exercise, stress management, social support, and reducing environmental toxins during radiation therapy to see if it improves biological processes related to cancer and enhances patients' quality of life.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (IO interventions)Experimental Treatment8 Interventions
Patients undergo up to 7 different IO intervention sessions per week during their 6-week course of radiotherapy for between 1 and 3 hours each session, in addition to, up to 6 aerobic training sessions per week and one grocery store trip during the course of the program. IO intervention programs consist of nutritional coaching, behavioral therapy, yoga and meditation practice, resistance training, and a weekly meal sharing and cooking class. Patients then have weekly meetings with the study psychologist on the computer for 6 months, followed by a monthly meeting on the computer from 6-12 months, and 2 hour meetings at all follow-up appointments during the first year after radiotherapy.
Group II: Arm II (standard of care)Active Control4 Interventions
Patients undergo standard of care.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
Loading ...
Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator