TeleHealth Resistance Exercise for Breast Cancer

(THRIVE-65 Trial)

Recruiting at 2 trial locations

Overseen By Jennifer Ligibel, MD

Age: 65+

Sex: Female

Trial Phase: Academic

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 All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 10-26 weeks

270 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether exercise with protein support or health education helps women undergoing chemotherapy for breast cancer adhere to their treatment schedule. Participants will either receive a tablet with health resources or work with a coach on exercise and diet. The study targets women aged 65 or older with stage I-III breast cancer who can walk at least two blocks. Participants should not already engage in regular strength training or competitive aerobic activities. As an unphased trial, this study offers participants the opportunity to contribute to valuable research that could enhance treatment experiences for future patients.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown the THRIVE exercise and protein intake program to be safe for participants. Research indicates that similar programs, which include home exercises and dietary support, are well-tolerated by most people. Related studies have reported no major negative effects, and participants generally manage the program well. This suggests that the THRIVE program is safe for those interested in joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to support breast cancer patients during chemotherapy. The THRIVE intervention is unique because it combines personalized exercise coaching with dietary support to help maintain muscle strength and overall fitness, which is not typically a focus of standard chemotherapy care. Meanwhile, the Health Education Support program offers a holistic approach with a tablet-based resource that includes yoga, meditation, and nutrition tips to enhance well-being. By integrating exercise and mindful practices into cancer care, this trial aims to improve patients' quality of life and potentially mitigate chemotherapy side effects, offering a fresh perspective beyond conventional treatments.

What evidence suggests that this trial's treatments could be effective for breast cancer?

Research has shown that exercise and adequate protein intake can benefit breast cancer patients undergoing chemotherapy. In this trial, participants in the THRIVE Exercise and Diet Intervention arm will work with a coach to gradually build exercise routines and ensure sufficient protein intake. Studies have found that this approach boosts muscle strength and overall fitness, making it easier for patients to cope with chemotherapy. Specifically, one study discovered that combining exercise with protein intake helps maintain muscle mass and may improve the chances of completing chemotherapy as planned. These approaches aim to help patients tolerate treatment better, keeping them stronger during chemotherapy. Meanwhile, participants in the Health Education Support Program arm will receive supportive care resources, including light stretching and gentle yoga, to aid them during chemotherapy. ^{1 3 5 6 7}

Who Is on the Research Team?

Jennifer Ligibel, MD

Principal Investigator

Dana-Farber Cancer Institute

Nathan Berger, MD

Principal Investigator

Case Western Reserve University/University Hospitals Cleveland

Kathryn Schmitz (contact), PhD, MPH

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Health Education Support Program
• THRIVE

Trial Overview

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.

How Is the Trial Designed?

Group I: THRIVE: EXERCISE INTERVENTION WITH PROTEIN INTAKE SUPPORT Experimental Treatment 1 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 GROUP Active Control 1 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.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

University of Pittsburgh

Collaborator

Trials

1,820

Recruited

16,360,000+

Penn State University

Collaborator

Trials

380

Recruited

131,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Case Western Reserve University

Collaborator

Trials

314

Recruited

236,000+

Published Research Related to This Trial

A study involving 230 breast cancer patients undergoing adjuvant chemotherapy found that both the low-intensity home-based program (Onco-Move) and the moderate- to high-intensity supervised program (OnTrack) significantly reduced declines in cardiorespiratory fitness and improved physical functioning compared to usual care.

The OnTrack program was particularly effective, leading to better muscle strength, reduced physical fatigue, and fewer chemotherapy dose adjustments, while both intervention groups allowed participants to return to work sooner and for more hours than the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. van Waart, H., Stuiver, MM., van Harten, WH., et al.[2022]

Breast cancer survivors with Medicaid insurance are less physically active and less likely to recognize the health benefits of exercise compared to those with non-Medicaid insurance, indicating a need for targeted support.

On-treatment and early survivors value health benefits from exercise more than late survivors, suggesting that exercise programs should be tailored to the specific needs and beliefs of survivors based on their treatment status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise programming and counseling preferences of breast cancer survivors during or after radiation therapy. Karvinen, KH., Raedeke, TD., Arastu, H., et al.[2011]

This pilot study will assess the feasibility of personalized virtual exercise training for 20 breast and prostate cancer survivors over 24 weeks, which includes 12 weeks of one-on-one training followed by 12 weeks of independent exercise using recorded sessions.

The study aims to evaluate the preliminary effects of this virtual program on various health metrics, such as body composition and exercise self-efficacy, potentially addressing barriers to physical activity in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Streaming Web-Based Exercise at Home Study for Breast and Prostate Cancer Survivors: A Feasibility Study Protocol. Shirazipour, CH., Ruggieri-Bacani, RM., Lockshon, L., et al.[2023]

In a year-long study involving 61 postmenopausal breast cancer survivors experiencing joint pain from aromatase inhibitors, participants successfully maintained an average of 119 minutes of moderate-intensity aerobic exercise per week and attended 70% of supervised training sessions.

The study found that baseline cardiorespiratory fitness (VO2max) was linked to higher exercise levels at 6 months, while older age was associated with better attendance at supervised sessions at 12 months, indicating that these factors can help predict exercise adherence in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise adherence in a randomized trial of exercise on aromatase inhibitor arthralgias in breast cancer survivors: the Hormones and Physical Exercise (HOPE) study. Arem, H., Sorkin, M., Cartmel, B., et al.[2023]

The STRENGTH trial involving 90 premenopausal breast cancer patients on chemotherapy demonstrated that home-based diet and exercise interventions can help prevent weight gain and preserve lean body mass during treatment.

The combination of a calcium-rich diet, exercise, and a high fruit and vegetable, low-fat diet led to a significant reduction in body fat percentage compared to the control group, highlighting the potential for dietary and exercise strategies to improve body composition in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of a diet/exercise feasibility trial to prevent adverse body composition change in breast cancer patients on adjuvant chemotherapy. Demark-Wahnefried, W., Case, LD., Blackwell, K., et al.[2021]

A 3-month remote intervention aimed at increasing physical activity among 34 younger breast cancer survivors showed high feasibility and acceptability, with participants engaging well with peer mentors and Fitbit tools.

Participants experienced significant improvements in physical activity levels and quality of life measures, including body image and emotional support, indicating that this type of intervention could be beneficial for younger breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A remotely delivered, peer-led intervention to improve physical activity and quality of life in younger breast cancer survivors. Weiner, LS., Nagel, S., Irene Su, H., et al.[2023]

In a study of 242 breast cancer patients undergoing chemotherapy, over half of the missed exercise sessions were due to disease and treatment-related barriers, highlighting the significant impact of chemotherapy side effects on exercise adherence.

The most common reasons for missing exercise sessions included feeling sick (12%), fatigue (11%), and loss of interest (9%), indicating that tailored behavioral support programs are needed to help patients maintain exercise despite these challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers to supervised exercise training in a randomized controlled trial of breast cancer patients receiving chemotherapy. Courneya, KS., McKenzie, DC., Reid, RD., et al.[2018]

A systematic review of nine studies involving 1127 breast cancer patients found that telehealth-based exercise interventions significantly improved physical activity, aerobic capacity, upper body function, and quality of life compared to usual care.

The telehealth exercise program also reduced fatigue and enhanced muscle strength, indicating it is an effective non-pharmacological treatment option for improving the overall well-being of breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a telehealth-based exercise intervention on the physical activity of patients with breast cancer: A systematic review and meta-analysis. Peng, Y., Zhang, K., Wang, L., et al.[2022]

Breast cancer survivors showed no significant differences in overall physical activity levels when comparing in-person cardiovascular rehabilitation (CR) to virtual CR during the COVID-19 pandemic, indicating that virtual options can maintain activity levels.

However, the variability in physical activity duration increased significantly after the transition to virtual CR, suggesting that while overall activity was maintained, the consistency of participation may have been affected, highlighting the need for tailored strategies to enhance engagement in virtual programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast cancer survivors' physical activity and experiences while transitioning to a virtual cardiovascular rehabilitation program during a pandemic (COVID-19). Larkin, J., Vanzella, L., Thomas, S., et al.[2022]

The ABRACE: Telehealth study is a randomized controlled trial involving breast cancer patients undergoing treatment, aiming to assess the effects of a 12-week telehealth exercise program combined with health education on cancer-related fatigue and other psychological outcomes.

The study hypothesizes that the multicomponent training program (MTHE) will be more effective than health education alone in improving physical activity levels, quality of life, and reducing symptoms of depression and anxiety in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth multicomponent exercise and health education in breast cancer patients undergoing primary treatment: rationale and methodological protocol for a randomized clinical trial (ABRACE: Telehealth). Henkin, JS., Botton, CE., Simon, MS., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11439870/

Testing home-based exercise strategies in underserved ...

The THRIVE trial is an 8-month prospective, three-arm study of 45 patients who are randomized in a 1:1:1 fashion to a supervised exercise ...

2.

reporter.nih.gov

reporter.nih.gov/project-details/10915046

Project Details

We propose a randomized controlled trial to assess the effects of a multicomponent, hybrid telehealth (TH) exercise and protein intake support (the THRIVE ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S155171442500268X

TeleHealth resistance exercise intervention to preserve ...

The THRIVE-65 trial is poised to answer a crucial scientific question: Can exercise and nutrition support improve chemotherapy tolerance among older breast ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05535192

TeleHealth Resistance Exercise Intervention to Preserve ...

Exercise: Participants in the THRIVE Intervention arm work with an exercise coach to participate in both muscle strengthening exercises and aerobic exercises.

5.

astrazeneca-us.com

astrazeneca-us.com/media/press-releases/2024/lynparza-demonstrated-clinically-meaningful-prolonged-survival-benefit-in-early-breast-cancer-in-olympia-phase-iii-trial.html

LYNPARZA® (olaparib) demonstrated clinically meaningful ...

LYNPARZA® (olaparib) demonstrated clinically meaningful prolonged survival benefit in early breast cancer in OlympiA Phase III trial · 87.5% of ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05327452

Testing Home-based Exercise Strategies in Underserved ...

The purpose of this research is to determine whether a 16 week, home-based, aerobic and resistance exercise intervention will increase physical activity ...

7.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.TPS12145

An open-label randomized trial of exercise ± creatine ...

We propose the THRIVE clinical trial to assess the effects of 12-weeks of CP supplementation in combination with home-based resistance exercise.