270 Participants Needed

TeleHealth Resistance Exercise for Breast Cancer

(THRIVE-65 Trial)

Recruiting at 2 trial locations
KS
JL
Overseen ByJennifer Ligibel, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

Is 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.12345

How 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.25678

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.457910

Who Is on the Research Team?

Jennifer A. Ligibel, MD - Dana-Farber ...

Jennifer Ligibel, MD

Principal Investigator

Dana-Farber Cancer Institute

NB

Nathan Berger, MD

Principal Investigator

Case Western Reserve University/University Hospitals Cleveland

KS

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.
See 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.
See 4 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: THRIVE: EXERCISE INTERVENTION WITH PROTEIN INTAKE SUPPORTExperimental Treatment1 Intervention
Group II: HEALTH EDUCATION AND SUPPORT CONTROL GROUPActive Control1 Intervention

Find a Clinic Near You

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

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

Citations

Exercise programming and counseling preferences of breast cancer survivors during or after radiation therapy. [2011]
Barriers to supervised exercise training in a randomized controlled trial of breast cancer patients receiving chemotherapy. [2018]
Results of a diet/exercise feasibility trial to prevent adverse body composition change in breast cancer patients on adjuvant chemotherapy. [2021]
Effect of a telehealth-based exercise intervention on the physical activity of patients with breast cancer: A systematic review and meta-analysis. [2022]
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]
Breast cancer survivors' physical activity and experiences while transitioning to a virtual cardiovascular rehabilitation program during a pandemic (COVID-19). [2022]
A remotely delivered, peer-led intervention to improve physical activity and quality of life in younger breast cancer survivors. [2023]
Exercise adherence in a randomized trial of exercise on aromatase inhibitor arthralgias in breast cancer survivors: the Hormones and Physical Exercise (HOPE) study. [2023]
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]
The Streaming Web-Based Exercise at Home Study for Breast and Prostate Cancer Survivors: A Feasibility Study Protocol. [2023]
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