Telehealth exercise program for older women with breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research assesses the effectiveness of a telehealth exercise intervention combined with protein intake support compared to a health education program for women aged 65 and older undergoing chemotherapy for breast cancer. Eligible participants will undergo baseline assessments before being randomized into one of the two intervention groups. The THRIVE Intervention includes muscle strengthening and aerobic exercises conducted via telehealth, along with dietary support to ensure adequate protein intake. Follow-up assessments will occur up to four weeks after chemotherapy completion to evaluate the impact of the interventions.

Why it matters

Who can join: the full rules

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 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 Criteria:

* 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

Where it's running

• Dana Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• Case Western Reserve University/University Hospitals Cleveland
  Cleveland, Ohio, United States Recruiting
• University of Pittsburgh
  Pittsburgh, Pennsylvania, United States Recruiting
• Mount Nittany Medical Center
  State College, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Kathryn Schmitz (contact), PhD, MPH — University of Pittsburgh
• Study coordinator: Kathryn Schmitz, PhD, MPH
• Email: schmitzk@upmc.edu
• Phone: 412-623-6216

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.