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

NCT05535192 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2026-04-23

No results posted yet for this study

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.

Conditions

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

Interventions

BEHAVIORAL

THRIVE

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

BEHAVIORAL

Health Education Support Program

Participants will receive a tablet with information and resources regarding mediation, stretching and gentle movement, relaxation and creative arts during chemotherapy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Case Western Reserve University

    collaborator OTHER
  • University of Pittsburgh

    collaborator OTHER
  • Dana-Farber Cancer Institute

    lead OTHER

Principal Investigators

  • Kathryn Schmitz (contact), PhD, MPH · University of Pittsburgh

  • Jennifer Ligibel, MD · Dana-Farber Cancer Institute

  • Nathan Berger, MD · Case Western Reserve University/University Hospitals Cleveland

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-20
Primary Completion
2026-09-30
Completion
2027-02-01

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05535192 on ClinicalTrials.gov