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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT05535192
Status
Recruiting
Apply to this trial

Conditions

  • Breast Cancer
  • Breast Cancer Female
  • Stage I Breast Cancer
  • Stage II Breast Cancer
  • Stage III Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • THRIVE — BEHAVIORAL
    The THRIVE Intervention will involve: 1\) one in-person exercise sessions, followed by twice-weekly, home-based exercise sessions, supervised remotely through telehealth, and 2) a remotely delivered dietary assessment and recommendations to support protein intake throughout the study
  • Health Education Support Program — BEHAVIORAL
    Participants will receive a tablet with information and resources regarding mediation, stretching and gentle movement, relaxation and creative arts during chemotherapy

Study Details

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.

Key Dates

Start date
Mar 20, 2023
Status verified
Apr 2026
Primary completion
Sep 30, 2026
Completion
Feb 1, 2027

Study Design

Enrollment
270 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

Received Dose Intensity (RDI) [ Time Frame: Baseline to 26 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02215
Jennifer Ligibel, MD
[email protected]
617-632-3800
Jennifer Ligibel, MD (PRINCIPAL_INVESTIGATOR)
Case Western Reserve University/University Hospitals ClevelandClevelandOhio44106
Nathan Berger, MD
[email protected]
Cynthia Owusu, MD
[email protected]
University of PittsburghPittsburghPennsylvania15232
Kathryn Schmitz, PhD, MPH
[email protected]
412-623-6216

Find similar trials in Boston, MA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Dana Farber Cancer Institute· Boston, MACase Western Reserve University/University Hospitals Cleveland· Cleveland, OHUniversity of Pittsburgh· Pittsburgh, PA

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