TeleHealth Resistance Exercise Intervention to Preserve Dose Intensity and Vitality in Elder Breast Cancer Patients (THRIVE-65)

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
United States
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
Ohio
Case Western Reserve University/University Hospitals Cleveland
RECRUITING
Cleveland
Pennsylvania
University of Pittsburgh
RECRUITING
Pittsburgh
Contact Information
Primary
Kathryn Schmitz, PhD, MPH
schmitzk@upmc.edu
412-623-6216
Backup
Jennifer Ligibel, MD
jennifer_ligibel@dfci.harvard.edu
617-632-3800
Time Frame
Start Date: 2023-03-20
Estimated Completion Date: 2027-02-01
Participants
Target number of participants: 270
Treatments
Active_comparator: HEALTH EDUCATION AND SUPPORT CONTROL GROUP
The research study procedures include screening for eligibility and a baseline visit to collect measurements and questionnaires. After the baseline appointment, participants randomized into the Heath Education Support Program will receive a tablet from the study that is pre-loaded with material to help support them during chemotherapy. The tablet materials will include supportive care and resources that focus on movement (light stretching and gentle yoga), soothing music, meditation/mindfulness, and recipes/cooking demos. Participants in this arm will be asked to fill out questionnaires at the start of each chemotherapy cycle to indicate any side effects from chemotherapy and the amount of time they spend engaging with the tablet. At the end of participants' chemotherapy, they will be asked to complete end-of-study measures.
Experimental: THRIVE: EXERCISE INTERVENTION WITH PROTEIN INTAKE SUPPORT
The research study procedures include screening for eligibility and a baseline visit to collect measurements and questionnaires. After the baseline appointment, participants randomized into the THRIVE Exercise and Diet Intervention will work with a coach to gradually build exercise and stay active during chemotherapy treatment. Participants will work with an exercise coach to reach the muscle strengthening and aerobic exercise goals of the study. Participants will also consult with a dietician to ensure adequate protein intake during the study. Participants in this arm will be asked to fill out questionnaires at the start of each chemotherapy cycle to indicate any side effects from chemotherapy. At the end of participants' chemotherapy, they will be asked to complete end-of-study measures.
Related Therapeutic Areas
Sponsors
Leads: Dana-Farber Cancer Institute
Collaborators: University of Pittsburgh, Case Western Reserve University, National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov