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TeleHealth Resistance Exercise for Breast Cancer (THRIVE-65 Trial)
N/A
Recruiting
Led By Nathan Berger, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Women age >65 diagnosed with stage I-III invasive breast cancer
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 26 weeks
Awards & highlights
THRIVE-65 Trial Summary
This trial is comparing an exercise and protein intervention against a health education program to see if it helps older women better adhere to their breast cancer chemo schedules.
Who is the study for?
Women over 65 with stage I-III invasive breast cancer, BMI of 18-50 kg/m2, starting chemotherapy for curative intent can join. They must be able to walk and understand English. Excluded are those highly active in the past 3 years, with dementia, substance abuse issues, on weight-loss meds or diets that conflict with the trial's diet.Check my eligibility
What is being tested?
The study is testing if a resistance exercise program combined with protein support (THRIVE) versus just health education helps older women undergoing chemotherapy for breast cancer stick to their treatment schedule and maintain their planned chemo dose.See study design
What are the potential side effects?
While specific side effects aren't listed for THRIVE or health education programs, potential risks may include muscle soreness from exercise and possible dietary changes due to increased protein intake.
THRIVE-65 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman over 65 with stage I-III invasive breast cancer.
THRIVE-65 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 26 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 26 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Received Dose Intensity (RDI)
Secondary outcome measures
Accelerometry
Anthropometric measure - height
Anthropometric measure - waist circumference
+11 moreTHRIVE-65 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: THRIVE: EXERCISE INTERVENTION WITH PROTEIN INTAKE SUPPORTExperimental Treatment1 Intervention
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.
Group II: HEALTH EDUCATION AND SUPPORT CONTROL GROUPActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
THRIVE
2017
N/A
~420
Find a Location
Who is running the clinical trial?
University of PittsburghOTHER
1,722 Previous Clinical Trials
16,342,666 Total Patients Enrolled
16 Trials studying Breast Cancer
3,111 Patients Enrolled for Breast Cancer
Penn State UniversityOTHER
355 Previous Clinical Trials
125,487 Total Patients Enrolled
1 Trials studying Breast Cancer
3 Patients Enrolled for Breast Cancer
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,716 Total Patients Enrolled
141 Trials studying Breast Cancer
22,347 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have not engaged in at least 90 minutes of moderate aerobic activity per week for three consecutive months in the past three years.I do not have any health issues or take medications that would stop me from joining an exercise program.I am currently taking medication to lose weight.I am starting a specific chemotherapy soon for my cancer treatment.You are on a special diet that is not compatible with the THRIVE diet, as determined by a dietitian.You have been doing strength training exercises at least twice a week for the past three months within the last three years.I can walk for 6 minutes or 2 blocks, with or without help.You have had issues with alcohol or drug abuse in the past year, including drinking a lot.I am in a drug trial that includes specific chemotherapy drugs unless they change it based on how I respond.Your weight is between 40 and 110 pounds for every 4 feet 11 inches of your height.I am a woman over 65 with stage I-III invasive breast cancer.You have a history of memory and thinking problems.
Research Study Groups:
This trial has the following groups:- Group 1: HEALTH EDUCATION AND SUPPORT CONTROL GROUP
- Group 2: THRIVE: EXERCISE INTERVENTION WITH PROTEIN INTAKE SUPPORT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any participants yet enrolled in this experiment?
"As per clinicaltrials.gov, this investigation is no longer recruited participants - the trial was originally posted on January 1st 2023 and updated lastly on November 28th 2022. However, there are presently 2614 other medical trials actively searching for patients to enroll in research."
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