Breast Cancer Clinical Trial
TeleHealth Resistance Exercise Intervention to Preserve Dose Intensity and Vitality in Elder Breast Cancer Patients
Summary
This research is being done to assess whether an exercise intervention with protein intake support vs a health education and support program will make it easier for women age 65 or older who are receiving chemotherapy for breast cancer to receive all of their planned chemotherapy according to schedule and at the planned dose.
Full Description
The research study procedures include screening for eligibility. After participants are determined to be eligible and have signed consent, they will participate in a baseline visit to collect measurements (e.g., weight/height/waist measurements) and questionnaires, a memory test, functional movement and strength testing, and a physical activity assessment. After baseline measures are collected, participants will be randomized to either the THRIVE Exercise and Diet Intervention or the Heath Education and Support Program during chemotherapy. There is a follow up visit 2-4 weeks after the completion of chemotherapy to repeat measurements and questionnaires.
The duration of the study will be 10-26 weeks, depending on the type of chemotherapy participants are receiving.
The THRIVE Intervention will involve:
Exercise: Participants in the THRIVE Intervention arm work with an exercise coach to participate in both muscle strengthening exercises and aerobic exercises. There are two in-person exercise sessions at the beginning of the study. The remainder of the exercise sessions are done weekly via telehealth throughout chemotherapy treatment.
Protein intake support: Participants in the THRIVE Intervention will meet with a dietitian to make sure they are eating enough protein throughout their chemotherapy treatments. Participants will be asked to keep a daily protein checklist and share this with the exercise coach each week.
The Health Education Support Program will involve:
- Health education tablet: Participants in the Health Education Support program will receive a tablet with information regarding mediation, stretching and gentle movement, relaxation and creative arts throughout chemotherapy.
Eligibility Criteria
Inclusion Criteria:
Women age >65
Diagnosed with stage I-III invasive breast cancer
BMI between 18-50 kg/m2
Scheduled to begin at least 10 weeks of neoadjuvant or adjuvant anthracycline or taxane-based chemotherapy for curative intent
If enrolled in clinical chemotherapy drug trial, considered eligible if regimen includes an anthracycline or a taxane, unless the trial alters the chemotherapy agents/doses according to patient response (e.g.; I-SPY trials)
Self-reported ability to walk for 6 minutes and/or 2 blocks (with or without assistive device)
Ability to provide written informed consent.
Ability to understand, speak, and read English. This is because many of the study instruments used are not readily available in multiple languages. Additionally, site-based study staff, such as exercise physiologists, are not bilingual and not all sites have access to interpreters.
Exclusion Criteria:
Following a therapeutic diet for co-morbid disease where the THRIVE diet would be contraindicated as assessed by the RD
Engaging in 2 or more sessions of strength training exercise per week over a period of at least 3 consecutive months within past 3 years
Engaging in 90 minutes or more of weekly aerobic activity of moderate intensity (e.g. brisk walking, aerobics/dance or bicycling) for at least 3 consecutive months within the past 3 years
Presence of medical conditions or medications that would prohibit participation in an exercise program
Current use of weight-loss medication
Self-report alcohol or substance abuse within the past 12 months, including at-risk drinking (defined as current consumption of >14 alcoholic drinks per week)
History of dementia
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There is 1 Location for this study
Boston Massachusetts, 02215, United States More Info
Principal Investigator
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