Telehealth exercise program for older women with breast cancer
TeleHealth Resistance Exercise Intervention to Preserve Dose Intensity and Vitality in Elder Breast Cancer Patients (THRIVE-65)
This study is testing if a telehealth exercise program with protein support can help older women with breast cancer feel better during and after chemotherapy compared to a regular health education program.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 270 (estimated) |
| Ages | 65 Years and up |
| Sex | Female |
| Sponsor | Dana-Farber Cancer Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Boston, Massachusetts and 2 other locations) |
| Trial ID | NCT05535192 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 65 and older diagnosed with stage I-III invasive breast cancer who are scheduled to begin chemotherapy.
Not a fit: Patients who are following a therapeutic diet for co-morbid diseases that contraindicate the THRIVE diet may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could help older women with breast cancer maintain their chemotherapy regimen and improve their overall vitality during treatment.
How similar studies have performed: Other studies have shown positive outcomes with exercise interventions during cancer treatment, suggesting this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Boston, Massachusetts and 2 other locations
- 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)
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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.