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

Launched by DANA-FARBER CANCER INSTITUTE · Sep 8, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at whether a special exercise program, combined with help on protein intake, can help women aged 65 and older who are undergoing chemotherapy for breast cancer. The goal is to see if this program can make it easier for these women to complete their chemotherapy on schedule and at the right dose. Participants will be compared to those who are in a health education program instead, to see which approach works better.

To join the study, women need to be 65 or older and diagnosed with stage I to III invasive breast cancer. They should be starting at least 10 weeks of chemotherapy meant to help cure their cancer. Participants should be able to walk for at least 6 minutes, with or without assistance, and must be comfortable reading and writing in English. Throughout the trial, participants can expect support from exercise specialists and nutrition experts, and they will be monitored closely to ensure their safety and well-being during the exercise program.

Gender

FEMALE

Eligibility 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