TeleHealth Resistance Exercise Intervention to Preserve Dose Intensity and Vitality in Elder Breast Cancer Patients
THRIVE-65
2 other identifiers
interventional
270
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Mar 2023
Typical duration for not_applicable breast-cancer
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2022
CompletedFirst Posted
Study publicly available on registry
September 10, 2022
CompletedStudy Start
First participant enrolled
March 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
April 23, 2026
April 1, 2026
3.5 years
August 29, 2022
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Received Dose Intensity (RDI)
Review of electronic medical records to discern chemotherapy dose received versus prescribed.
Baseline to 26 weeks
Secondary Outcomes (14)
Patient-reported chemotoxicities
Baseline to 26 weeks
Measure of hematologic chemotoxicity - Hematocrit
Baseline to 26 weeks
Measure of hematologic chemotoxicity- White blood cell count
Baseline to 26 weeks
Measure of hematologic chemotoxicity - Platelet count
Baseline to 26 weeks
Measure of hematologic chemotoxicity - Neutrophil count
Baseline to 26 weeks
- +9 more secondary outcomes
Study Arms (2)
HEALTH EDUCATION AND SUPPORT CONTROL GROUP
ACTIVE COMPARATORThe 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.
THRIVE: EXERCISE INTERVENTION WITH PROTEIN INTAKE SUPPORT
EXPERIMENTALThe 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.
Interventions
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
Participants will receive a tablet with information and resources regarding mediation, stretching and gentle movement, relaxation and creative arts during chemotherapy
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- National Cancer Institute (NCI)collaborator
- Case Western Reserve Universitycollaborator
- University of Pittsburghcollaborator
Study Sites (3)
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Case Western Reserve University/University Hospitals Cleveland
Cleveland, Ohio, 44106, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15232, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kathryn Schmitz (contact), PhD, MPH
University of Pittsburgh
- PRINCIPAL INVESTIGATOR
Jennifer Ligibel, MD
Dana-Farber Cancer Institute
- PRINCIPAL INVESTIGATOR
Nathan Berger, MD
Case Western Reserve University/University Hospitals Cleveland
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 29, 2022
First Posted
September 10, 2022
Study Start
March 20, 2023
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
February 1, 2027
Last Updated
April 23, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.