TeleHealth Resistance Exercise Intervention to Preserve Dose Intensity and Vitality in Elder Breast Cancer Patients
TeleHealth Resistance Exercise Intervention to Preserve Dose Intensity and Vitality in Elder Breast Cancer Patients (THRIVE-65)
Dana-Farber Cancer Institute
270 participants
Mar 20, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- 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 cytotoxic 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 Criteria7
- Following a therapeutic diet for co-morbid disease where the THRIVE-65 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 over the past year
- Engaging in aerobic activity at a level that includes competitive events (e.g., marathon, triathlon, running races) over the past year
- Presence of medical conditions or medications that would prohibit participation in an exercise program
- Current use of weight-loss medication
- Documented history of alcohol or substance abuse within the past 12 months
- History of dementia
Interventions
The THRIVE Intervention will involve: 1\) one in-person exercise sessions, followed by twice-weekly, home-based exercise sessions, supervised remotely through telehealth, and 2) a remotely delivered dietary assessment and recommendations to support protein intake throughout the study
Participants will receive a tablet with information and resources regarding mediation, stretching and gentle movement, relaxation and creative arts during chemotherapy
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05535192