Breast CancerTHRIVE-65NCT05535192
TeleHealth Resistance Exercise Intervention to Preserve Dose Intensity and Vitality in Elder Breast Cancer Patients
A study testing THRIVE and Health Education Support Program in people with Breast Cancer and Stage III Breast Cancer, run by Dana-Farber Cancer Institute at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Breast Cancer, Stage III Breast Cancer, Breast Cancer Female
- What is being tested?
- THRIVE and Health Education Support Program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 4 sitesUnited States
- Study dates
- 20 Mar 2023to 1 Feb 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Jennifer Ligibel, MD, 617-632-3800, Jennifer_Ligibel@dfci.harvard.edu
Jennifer Ligibel, MD
- Recruiting
Case Western Reserve University/University Hospitals Cleveland
Cleveland, Ohio, 44106
Cynthia Owusu, MD, cxo34@case.edu
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15232
Kathryn Schmitz, PhD, MPH, 412-623-6216, schmitzk@upmc.edu
- Recruiting
Mount Nittany Medical Center
State College, Pennsylvania, 16803
Shannon Fisher, 8142317813, sfisher@mountnittany.org
About this study
Official title: TeleHealth Resistance Exercise Intervention to Preserve Dose Intensity and Vitality in Elder Breast Cancer Patients (THRIVE-65)
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.
Read the detailed description
The research study procedures include screening for eligibility. After participants are determined to be eligible and have signed consent, they will participate in a baseline visit to collect measurements (e.g., weight/height/waist measurements) and questionnaires, a memory test, functional movement and strength testing, and a physical activity assessment. After baseline measures are collected, participants will be randomized to either the THRIVE Exercise and Diet Intervention or the Heath Education and Support Program during chemotherapy. There is a follow up visit up to 4 weeks after the completion of chemotherapy to repeat measurements and questionnaires.
The duration of the study will be 10-26 weeks, depending on the type of chemotherapy participants are receiving.
The THRIVE Intervention will involve:
- Exercise: Participants in the THRIVE Intervention arm work with an exercise coach to participate in both muscle strengthening exercises and aerobic exercises. There is one in-person exercise session at the beginning of the study. The remainder of the exercise sessions are done twice weekly via telehealth throughout chemotherapy treatment.
- Protein intake support: Participants in the THRIVE Intervention will meet with a dietitian to make sure they are eating enough protein throughout their chemotherapy treatments. Participants will be asked to keep a daily protein checklist and share this with the exercise coach each week.
The Health Education Support Program will involve:
- Health education tablet: Participants in the Health Education Support program will receive a tablet with information regarding mediation, stretching and gentle movement, relaxation and creative arts throughout chemotherapy.
- Conditions
- Breast Cancer, Stage III Breast Cancer, Breast Cancer Female, Stage I Breast Cancer, Stage II Breast Cancer
- Being tested
- THRIVE, Health Education Support Program
- Keywords
- Breast Cancer, Stage III Breast Cancer, Stage II Breast Cancer, Stage I Breast Cancer, Exercise Intervention, Nutrition Intervention, Supportive Care
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THRIVEBehavioural
The THRIVE Intervention will involve:
- 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 ProgramBehavioural
Participants will receive a tablet with information and resources regarding mediation, stretching and gentle movement, relaxation and creative arts during chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| HEALTH EDUCATION AND SUPPORT CONTROL GROUP | Active comparator | 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. Receives: Behavioral: Health Education Support Program |
| THRIVE: EXERCISE INTERVENTION WITH PROTEIN INTAKE SUPPORT | Experimental | 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. Receives: Behavioral: THRIVE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Received Dose Intensity (RDI)
Review of electronic medical records to discern chemotherapy dose received versus prescribed.
Measured: Baseline to 26 weeks
Secondary outcomes (14)
Patient-reported chemotoxicities
Participants will be asked to complete the PRO-CTCAE survey at each chemotherapy cycle. This well-validated survey includes symptoms and adverse events related to chemotherapy. The constructs we will measure include mouth/throat sores, nausea, constipation, diarrhea, neuropathy, concentration, memory, pain, insomnia, and fatigue. A level of 3 or higher will be the threshold for defining a chemotoxicity (yes/no).
Measured: Baseline to 26 weeks
Measure of hematologic chemotoxicity - Hematocrit
Review of medical record to abstract hematocrit values (% of red blood cells in blood).
Measured: Baseline to 26 weeks
Measure of hematologic chemotoxicity- White blood cell count
Review of medical record to abstract white blood cell count.
Measured: Baseline to 26 weeks
Measure of hematologic chemotoxicity - Platelet count
Review of medical record to abstract platelet count.
Measured: Baseline to 26 weeks
Measure of hematologic chemotoxicity - Neutrophil count
Review of medical record to abstract neutrophil count.
Measured: Baseline to 26 weeks
Accelerometry
Physical activity will be measured objectively using Actigraph accelerometry. Accelerometer data will include estimated average metabolic equivalents expended daily and in hours/week as well as time in sedentary, low, moderate and vigorous activity.
Measured: Baseline to 26 weeks
Morgenstern Physical Activity Questionnaire (PAQ-M)
Self-reported physical activity will be measured at baseline and end-of-study using the Morgenstern Physical Activity Questionnaire (PAQ-M), which has been used to reliably capture recreational, occupational and household activity in sedentary adults.
Measured: Baseline to 26 weeks
Diet
Dietary intake will be estimated using repeat administrations of the self-reported, validated Arizona Food Frequency Questionnaire. This questionnaire has been used extensively in large dietary intervention trials among cancer survivors. The instrument will be completed by patients during baseline and end of chemotherapy, reflecting on previous 4 weeks of usual dietary intake.
Measured: Baseline to 26 weeks
Strength
Participants will undergo 10 Repetition Submaximal Strength Testing at baseline and follow-up, collected by the site-based exercise trainer, using a standardized protocol.
Measured: Baseline to 26 weeks
MOS SF-36 Questionnaire
General health-related quality of life (including vitality) will be assessed at baseline and end-of-study using the well-validated MOS SF-36 survey.
Measured: Baseline to 26 weeks
Pittsburgh Sleep Quality Index (PSQI)
Sleep will be assessed at baseline and end-of-study using the PSQI, which is a widely used measure of subjective sleep disturbance; its validity and reliability have been established in various clinical populations, including patients with cancer.
Measured: Baseline to 26 weeks
Anthropometric measure - height
Measure of participant height in centimeters.
Measured: Baseline to 26 weeks
Anthropometric measure - weight
Measure of participant weight in centimeters.
Measured: Baseline to 26 weeks
Anthropometric measure - waist circumference
Measure of participant waist circumference in centimeters.
Measured: Baseline to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start20 Mar 2023
- Primary completion30 Sep 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Case Western Reserve University, University of Pittsburgh
- Responsible party
- Principal investigator, Jennifer A. Ligibel, MD, Dana-Farber Cancer Institute
- Investigators
- Kathryn Schmitz (contact), PhD, MPH, Principal investigator, University of PittsburghJennifer Ligibel, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05535192
- Sponsor's protocol ID
- 22-250
- Other IDs
- 1U01CA271277-01
- Acronym
- THRIVE-65
- Status last verified
- Apr 2026
- First submitted
- 29 Aug 2022
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.