TeleHealth Resistance Exercise for Older Breast Cancer Patients

This study is for women aged 65 or older with Stage I-III breast cancer who are starting chemotherapy. Researchers want to see if a program called THRIVE helps you receive all your planned chemotherapy doses on schedule. THRIVE involves one in-person exercise session followed by twice-weekly home exercises supervised remotely through telehealth, plus dietary advice to ensure enough protein intake. This is compared to a Health Education Support Program that provides information on meditation, stretching, and relaxation. The main goal is to see if THRIVE helps you complete your chemotherapy as planned. The study is currently unclear on its recruitment status.

Study design
This is an interventional study planning to enroll 270 participants. You would be randomly assigned to either the THRIVE program or the Health Education Support Program.
What's involved
You would have a baseline visit for measurements and tests, then participate in your assigned program for 10-26 weeks during chemotherapy, followed by a final visit.
Compensation
Not stated in the trial record.
Follow-up
You will have a follow-up visit up to 4 weeks after completing chemotherapy.

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NCT05535192

TeleHealth Resistance Exercise Intervention to Preserve Dose Intensity and Vitality in Elder Breast Cancer Patients

Recruiting
NAAges 65+InterventionalSupportive care
Dana-Farber Cancer Institute
~270 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:THRIVEHealth Education Support Program

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Received Dose Intensity (RDI)
Measured over Baseline to 26 weeks
Breast Cancer
Stage III Breast Cancer
Breast Cancer Female
Stage I Breast Cancer
Stage II Breast Cancer
4 sites across 3 states
Pennsylvania2
Massachusetts1
Ohio1
  • Kathryn Schmitz (contact), PhD, MPH · PRINCIPAL_INVESTIGATOR · University of Pittsburgh
  • Jennifer Ligibel, MD · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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
  • Received Dose Intensity (RDI)Baseline to 26 weeks

    Review of electronic medical records to discern chemotherapy dose received versus prescribed.