Actively Recruiting
TeleHealth Resistance Exercise Intervention to Preserve Dose Intensity and Vitality in Elder Breast Cancer Patients (THRIVE-65)
Led by Dana-Farber Cancer Institute · Updated on 2026-04-23
270
Participants Needed
3
Research Sites
17 weeks
Total Duration
On this page
Sponsors
D
Dana-Farber Cancer Institute
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether a combined exercise and protein intake program compared to a health education and support program can help women aged 65 and older with breast cancer complete their planned chemotherapy on schedule and at the intended dose. This study focuses on older women receiving chemotherapy for stage I to III invasive breast cancer and aims to support their treatment adherence and vitality during therapy. Participants will be randomly assigned to one of two groups. The THRIVE Intervention group will have one in-person exercise session initially, followed by twice-weekly remote exercise sessions via telehealth, including muscle strengthening and aerobic exercises, along with dietary support from a dietitian to ensure adequate protein intake. The Health Education Support group will receive a tablet loaded with materials on meditation, gentle movement, relaxation, and creative arts to support them during chemotherapy. Before starting, eligible participants will complete baseline assessments including physical measurements, questionnaires, memory tests, and physical activity evaluations. During chemotherapy, participants will report side effects and engagement with their assigned program. Follow-up assessments will occur up to four weeks after chemotherapy completion, measuring received dose intensity, physical strength, blood counts, sleep quality, diet, activity levels, and other health indicators. The study duration ranges from 10 to 26 weeks depending on chemotherapy type.
CONDITIONS
Brief Title
TeleHealth Resistance Exercise Intervention to Preserve Dose Intensity and Vitality in Elder Breast Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women age 65 or older
- Diagnosed with stage I to III invasive breast cancer
- Body mass index between 18 and 50 kg/m2
- Scheduled to begin at least 10 weeks of neoadjuvant or adjuvant cytotoxic chemotherapy for curative intent
- If enrolled in a chemotherapy drug trial, eligible if regimen includes anthracycline or taxane unless doses change with response
- Self-reported ability to walk for 6 minutes or 2 blocks, with or without assistive device
- Ability to provide written informed consent
- Ability to understand, speak, and read English
You will not qualify if you...
- Following a therapeutic diet contraindicated with the THRIVE-65 diet
- Engaging in strength training twice or more per week for at least 3 consecutive months in the past year
- Participating in aerobic activities involving competitive events like marathons or triathlons in the past year
- Medical conditions or medications that prevent participation in an exercise program
- Current use of weight-loss medication
- History of alcohol or substance abuse within the past 12 months
- History of dementia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants attend a baseline visit to collect measurements such as weight, height, and waist circumference, complete questionnaires, a memory test, functional movement and strength testing, and a physical activity assessment.
1 visit (in-person)
Duration - 10 to 26 weeks depending on chemotherapy regimen
Participants receive either the THRIVE Exercise and Diet Intervention or the Health Education and Support Program during chemotherapy. The THRIVE Intervention includes one in-person exercise session followed by twice-weekly telehealth exercise sessions and dietary support for protein intake. The Health Education Support Program provides a tablet with supportive care materials for use throughout chemotherapy.
Twice-weekly telehealth exercise sessions (THRIVE arm) and regular questionnaire assessments at the start of each chemotherapy cycle
Duration - Up to 4 weeks
Participants attend a follow-up visit up to 4 weeks after completing chemotherapy to repeat measurements and questionnaires.
1 visit (in-person)
Trial Site Locations
Total: 3 locations
1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
Case Western Reserve University/University Hospitals Cleveland
Cleveland, Ohio, United States, 44106
Actively Recruiting
3
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
Research Team
K
Kathryn Schmitz, PhD, MPH
J
Jennifer Ligibel, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here