TeleHealth Resistance Exercise Intervention to Preserve Dose Intensity and Vitality in Elder Breast Cancer Patients
Recruiting · NCT05535192 · Interventional (participants receive a specific treatment) · Lead sponsor: Dana-Farber Cancer Institute
View the official record on ClinicalTrials.gov →Interventions studied
Health Education Support ProgramTHRIVE
What this trial is about
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.
Who can take part
Age range
65 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
4 locations listed across 3 US states.
- Dana Farber Cancer Institute - Boston, Massachusetts, United States
- Case Western Reserve University/University Hospitals Cleveland - Cleveland, Ohio, United States
- University of Pittsburgh - Pittsburgh, Pennsylvania, United States
- Mount Nittany Medical Center - State College, Pennsylvania, United States