TeleHealth Resistance Exercise for Breast Cancer
(THRIVE-65 Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 65+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Dana-Farber Cancer Institute
Must not be taking: Weight-loss medication
Disqualifiers: Therapeutic diet, Strength training, Aerobic activity, Alcohol abuse, Dementia, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications, but it does exclude those with medical conditions or medications that would prevent participation in an exercise program. It's best to discuss your specific medications with the trial coordinators.
What data supports the effectiveness of the treatment TeleHealth Resistance Exercise for Breast Cancer?
Research shows that telehealth-based exercise programs can significantly improve physical activity, muscle strength, fatigue, and quality of life in breast cancer patients compared to usual care. This suggests that such programs are beneficial as part of a comprehensive treatment for breast cancer.
12345Is TeleHealth Resistance Exercise for Breast Cancer safe for humans?
Research on exercise programs for breast cancer patients, including home-based and virtual interventions, suggests they are generally safe and can improve physical fitness and quality of life. These studies did not report significant safety concerns, indicating that such exercise programs are well-tolerated by participants.
35678How does the THRIVE treatment differ from other treatments for breast cancer?
The THRIVE treatment is unique because it combines telehealth-based resistance exercise with health education, offering a remote and accessible way for breast cancer patients to improve physical activity and quality of life during treatment, unlike traditional in-person exercise programs.
347910Eligibility Criteria
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.Inclusion Criteria
I am starting a specific chemotherapy soon for my cancer treatment.
I can walk for 6 minutes or 2 blocks, with or without help.
I am in a drug trial that includes specific chemotherapy drugs unless they change it based on how I respond.
+4 more
Exclusion 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.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Baseline
Baseline visit to collect measurements, questionnaires, memory test, functional movement and strength testing, and physical activity assessment
1 week
1 visit (in-person)
Treatment
Participants are randomized to either the THRIVE Exercise and Diet Intervention or the Health Education and Support Program during chemotherapy
10-26 weeks
1 visit (in-person), bi-weekly telehealth sessions
Follow-up
Follow-up visit up to 4 weeks after the completion of chemotherapy to repeat measurements and questionnaires
4 weeks
1 visit (in-person)
Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of PittsburghPittsburgh, PA
Case Western Reserve University/University Hospitals ClevelandCleveland, OH
Dana Farber Cancer InstituteBoston, MA
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Who Is Running the Clinical Trial?
Dana-Farber Cancer InstituteLead Sponsor
University of PittsburghCollaborator
Penn State UniversityCollaborator
National Cancer Institute (NCI)Collaborator
Case Western Reserve UniversityCollaborator
References
Exercise programming and counseling preferences of breast cancer survivors during or after radiation therapy. [2011]To explore exercise programming and counseling preferences and exercise-related beliefs in breast cancer survivors during and after radiation therapy, and to compare differences based on treatment and insurance status.
Barriers to supervised exercise training in a randomized controlled trial of breast cancer patients receiving chemotherapy. [2018]Exercise adherence is a challenge for breast cancer patients receiving chemotherapy but few studies have identified the key barriers.
Results of a diet/exercise feasibility trial to prevent adverse body composition change in breast cancer patients on adjuvant chemotherapy. [2021]Patients with breast cancer on adjuvant chemotherapy can experience weight gain and concurrent losses in muscle mass. Exercise interventions can prevent these changes, but time and travel pose barriers to participation. The Survivor Training for Enhancing Total Health (STRENGTH) trial assessed the feasibility and impact of 2 home-based interventions.
Effect of a telehealth-based exercise intervention on the physical activity of patients with breast cancer: A systematic review and meta-analysis. [2022]Telehealth-based exercise intervention as a non-pharmacological intervention has gradually emerged in breast cancer (BC), which shows feasibility and high levels of patient satisfaction. This systematic review aims to identify the effect of telehealth-based exercise interventions on the physical activity (PA) of patients with BC. We searched CENTRAL, CINAHL, PsycINFO, EMBASE, PubMed, Web of Science, ClinicalTrials.gov, CNKI, Wanfang, VIP, and SinoMed. Study selection and quality appraisal were performed independently by two reviewers. The review protocol was registered in PROSPERO (CRD42022326484). Nine studies, which included 1127 patients with BC, were identified. Compared with usual care, the telehealth-based exercise intervention had a significantly positive effect on PA (Standardized mean difference (SMD) = 0.26, 95% confidence interval (CI) 0.09 to 0.43, P = 0.003), aerobic capacity (SMD = 0.20, 95% CI 0.03 to 0.38, P = 0.02), upper body function (Mean difference (MD) = -4.56, 95% CI -7.66 to -1.47, P = 0.004), upper muscle strength (SMD = 0.26, 95% CI 0.09 to 0.42, P = 0.002), lower muscle strength (SMD = -0.95, 95% CI -1.27 to -0.62, P < 0.00001), abdominal muscle strength (MD = 23.85, 95% CI 13.84 to 33.86, P < 0.000,01), fatigue (SMD = 0.56, 95% CI 0.13 to 1.00, P = 0.01), and quality of life (SMD = 0.26, 95% CI 0.04 to 0.49, P = 0.02). Conversely, anthropometric and body composition and pain did not differ significantly between the two groups. Telehealth-based exercise intervention improved PA, physical performance, fatigue, and quality of life of patients with BC compared with routine care, which should be promoted clinically as a comprehensive treatment for BC.
Effect of Low-Intensity Physical Activity and Moderate- to High-Intensity Physical Exercise During Adjuvant Chemotherapy on Physical Fitness, Fatigue, and Chemotherapy Completion Rates: Results of the PACES Randomized Clinical Trial. [2022]We evaluated the effectiveness of a low-intensity, home-based physical activity program (Onco-Move) and a moderate- to high-intensity, combined supervised resistance and aerobic exercise program (OnTrack) versus usual care (UC) in maintaining or enhancing physical fitness, minimizing fatigue, enhancing health-related quality of life, and optimizing chemotherapy completion rates in patients undergoing adjuvant chemotherapy for breast cancer.
Breast cancer survivors' physical activity and experiences while transitioning to a virtual cardiovascular rehabilitation program during a pandemic (COVID-19). [2022]Breast cancer accounts for 25% of all cancers among Canadian females. Despite successes of decreased mortality, adverse treatment effects, such as cardiotoxicity, contribute to a sedentary lifestyle and decreased quality of life. Physical activity (PA) is a possible therapy for the late effects; however, COVID-19 restricted access to in-person cardiovascular rehabilitation (CR) programs. The purposes are as follows: (1) compare PA of breast cancer survivors' in-person CR to virtual CR following a transition during COVID-19 and (2) compare the PA of the pandemic cohort to a matched cohort who had completed the program in 2018/2019; (3) explore survivors' experiences of transitioning to and engaging in virtual CR. Mixed methods included analysis of CR PA data from a pandemic cohort (n = 18) and a 2018/2019 cohort (n = 18) and semi-structured focus group interviews with the pandemic cohort (n = 9) in the context of the PRECEDE-PROCEED model. After the transition, there were no significant differences in mean activity duration, frequency, and cumulative activity (expressed as MET-minutes) (p > 0.05). However, variation of PA duration doubled following the transition from in-person to virtual (p = 0.029), while for the 2018/2019 cohort, variation remained unchanged. Focus groups revealed that women valued their CR experiences pre-COVID-19 and had feelings of anxiety during the transition. Perceived factors affecting participation were environmental, personal, and behavioural. Recommendations for virtual programs were to increase comradery, technology, and professional guidance. PA experiences during a transition to virtual care prompted by a pandemic vary among breast cancer survivors. Targeting individualised strategies and exercise prescriptions are important for improving PA programs and patient outcomes.
A remotely delivered, peer-led intervention to improve physical activity and quality of life in younger breast cancer survivors. [2023]Younger breast cancer survivors (YBCS) consistently report poorer quality of life (QOL) than older survivors. Increasing physical activity (PA) may improve QOL, but this has been understudied in YBCS. This single arm pilot study evaluated the feasibility and acceptability of a 3-month, peer-delivered, remote intervention to increase PA and improve QOL in YBCS. Data were collected from October 2019 - July 2020. Participants (n = 34, 43.1 ± 5.5 years old, 46 ± 34.4 months post-diagnosis, BMI = 30.2 ± 7.4 kg/m2) completed six video sessions with a trained peer mentor; self-monitored PA with a Fitbit activity tracker; and interacted with a private Fitbit Community for social support. At baseline, 3-and 6-months, participants completed QOL questionnaires and PA was measured through accelerometer (moderate-to-vigorous PA [MVPA]) and self-report (strength and flexibility). A parallel mixed-methods approach (qualitative interviews and quantitative satisfaction survey at 3-months) explored intervention feasibility and acceptability. One-way repeated-measures ANOVAs examined impacts on PA and QOL at 3-and 6-months. The intervention was feasible as evidenced by efficient recruitment, high retention, and adherence to intervention components. Remote delivery, working with a peer mentor, and using Fitbit tools were highly acceptable. From baseline to 3-months, participants increased time spent in objectively measured MVPA, strength, and flexibility exercises, and reported meaningful improvements to body image, fatigue, anxiety, and emotional support. A fully remote, peer-to-peer intervention is an acceptable and promising strategy to increase PA and improve QOL in YBCS. Refinements to the intervention and its delivery should be further assessed in future studies, toward the goal of disseminating an evidence-based, scalable intervention to the growing number of YBCS.Trial registration Prospectively registered as NCT04064892.
Exercise adherence in a randomized trial of exercise on aromatase inhibitor arthralgias in breast cancer survivors: the Hormones and Physical Exercise (HOPE) study. [2023]Up to 50 % of postmenopausal breast cancer survivors taking aromatase inhibitors (AIs) experience AI-associated arthralgias, or joint pain, which causes many to stop taking AIs and may inhibit exercise, despite known health benefits. We thus evaluated exercise adherence and factors associated with better exercise adherence in breast cancer survivors experiencing AI-induced arthralgia in the (HOPE) year long randomized controlled trial.
Telehealth multicomponent exercise and health education in breast cancer patients undergoing primary treatment: rationale and methodological protocol for a randomized clinical trial (ABRACE: Telehealth). [2023]Current guidelines emphasize cancer patients should increase their physical activity levels, encouraging physical exercise practice as a complementary therapy to mitigate adverse effects during treatment. Telehealth can be a feasible method to improve adherence and interventional support for breast cancer patients, of which most do not meet sufficient physical activity levels after diagnosis. The Adaptations to Breast Cancer and Exercise Using Telehealth (ABRACE: Telehealth) study aims to investigate the effects of a 12-week telehealth multicomponent training program plus a health education program (MTHE), compared to a health education program alone (HE), on physical and psychological outcomes in breast cancer patients undergoing treatment.
The Streaming Web-Based Exercise at Home Study for Breast and Prostate Cancer Survivors: A Feasibility Study Protocol. [2023]Label="BACKGROUND" NlmCategory="BACKGROUND">Despite the known benefits of physical activity in cancer survivors, adherence to exercise guidelines remains low. Known barriers to adhering to guidelines include a lack of time and an unwillingness to return to treatment facilities. Virtual exercise programming could assist in mitigating these barriers. This protocol presents a single arm pilot study exploring the feasibility of personalized Zoom-delivered exercise training for breast and prostate cancer survivors. A secondary objective is to determine the preliminary efficacy of participation on body composition, estimated VO2max, hand grip, one repetition maximum leg press, resting heart rate, resting blood pressure, exercise self-efficacy, and intentions to remain active.