Physical Activity Promotion for Breast and Endometrial Cancer Survivors

No longer recruiting at 1 trial location

Overseen By Lisa Cadmus-Bertram, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Metastatic disease, Severe orthopedic conditions, others

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

Compensation: Varies

Number of Visits: 14

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help breast and endometrial cancer survivors increase their physical activity through innovative technology. Participants begin with a Fitbit and online health integration to track their progress. If initial responses are insufficient, additional support such as online gym access or coaching calls may be provided. The trial targets women diagnosed with certain cancer stages in the past five years who currently engage in less than an hour of exercise per week. Participants must have internet access and be comfortable using a smartphone. As an unphased trial, this study offers a unique opportunity for participants to enhance their health with personalized support and cutting-edge technology.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you may still be undergoing endocrine or Her2 therapies while participating.

What prior data suggests that this physical activity intervention is safe for breast and endometrial cancer survivors?

Research shows that exercise is generally safe for cancer survivors and can enhance their quality of life and health. Studies have found that breast and endometrial cancer survivors respond well to using a Fitbit connected to electronic health records. Participants in these studies received weekly feedback on their progress without major issues.

For those needing extra support, joining an online gym program has proven successful for endometrial cancer survivors, allowing them to exercise at home without significant problems. Additionally, coaching calls have been safe and effective, with many cancer survivors consistently attending wellness coaching sessions.

Overall, these activities are safe and well-received, offering promising ways to help cancer survivors become more active. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to boost physical activity among breast and endometrial cancer survivors. Unlike traditional exercise programs, this approach integrates technology by using Fitbit activity trackers connected to electronic health records (EHR), allowing participants to receive personalized messages through their patient portal. For participants who don't initially respond, the trial uniquely offers "stepped-up" options, like access to an online gym or personalized coaching calls, tailoring the intervention to individual needs. This combination of wearable tech and personalized support could lead to more effective and engaging ways for survivors to maintain healthy activity levels.

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

Research has shown that exercise can benefit cancer survivors by enhancing physical abilities, reducing cancer-related symptoms, and improving overall quality of life. In this trial, all participants will initially receive a Fitbit with electronic health records (EHR) integration to track progress and encourage increased activity. Participants needing more support will be randomized to receive additional interventions. One option is joining an online gym, which may not improve overall quality of life but does enhance physical fitness. Another option is coaching calls, which have been shown to reduce stress and improve communication, aiding survivors in better health management. These activities aim to support cancer survivors in staying active and healthy. ^{2 4 6 7 8}

Who Is on the Research Team?

Kristen Pickett, Ph.D.

Principal Investigator

University of Wisconsin, Madison

Siobhan Phillips, Ph.D., MPH

Principal Investigator

Northwestern University, Chicago

Are You a Good Fit for This Trial?

This trial is for female adults over 18 who've had Stage I-III breast or Stage I-II Type 1 endometrial cancer and are at least 3 months post primary treatment. They should be doing less than 60 minutes of moderate exercise per week, have internet access, speak English, and can attend study visits in Wisconsin or Chicago. Those with severe health issues preventing exercise or other conflicting conditions cannot join.

Inclusion Criteria

Insufficiently active, defined as ≤60 min/week of MVPA, performed in bouts of ≥10 minutes. This is 40% of the recommended amount of MVPA based on the 2008 Federal Guidelines and the American Cancer Society's guidelines for cancer survivors. The 7-Day Recall will be used to screen for physical activity; eligibility will be confirmed prior to randomization using the ActiGraph accelerometer

I finished my main cancer treatment at least 3 months ago but may still be on hormone or HER2 therapy.

I was diagnosed with early-stage breast or endometrial cancer in the last 5 years.

Exclusion Criteria

Current enrollment in another dietary or physical activity trial

I struggle to walk 1 block or can't work towards health goals.

I don't have conditions like a recent heart attack, severe bone issues, cancer spread, or upcoming surgery that would stop me from exercising.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Minimal Intervention

Participants receive a Fitbit activity tracker with EHR integration, including messages delivered via the EHR's patient portal. Evaluated for response/non-response every 4 weeks until week 20.

20 weeks

Evaluations every 4 weeks

Augmentation Phase

Non-responders are randomized to receive either online gym access or coaching calls as additional support.

Variable, based on response

Evaluations every 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with primary outcomes measured at 6, 12, and 30 months.

30 months

Data collection at 6, 12, and 30 months

What Are the Treatments Tested in This Trial?

Interventions

• Physical Activity Promotion

Trial Overview The trial tests a physical activity program designed to increase exercise among breast and endometrial cancer survivors. It includes using a Fitbit with electronic health record integration, coaching calls, and an online gym to encourage more frequent and intense physical activity.

How Is the Trial Designed?

Group I: Nonresponders -Stepped up to Online gym Experimental Treatment 2 Interventions

Non-responders to 'fitbit with EHR integration' will be randomized to be "stepped up" to one of two augmentation strategies(either Online gym or coaching calls). This arm will be stepped up to Online gym.

Group II: Nonresponders -Stepped up to Coaching calls Experimental Treatment 2 Interventions

Non-responders to 'fitbit with EHR integration' will be randomized to be "stepped up" to one of two augmentation strategies(either Online gym or coaching calls). This arm will be stepped up to Coaching calls.

Group III: Base intervention- Fitbit with EHR integration Experimental Treatment 1 Intervention

All participants will receive a first-line intervention (i.e., Fitbit activity tracker with EHR integration including messages delivered via the EHR's patient portal) and will be evaluated for response/non-response every 4 weeks until week 20.

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A 12-week behavior change intervention significantly increased physical activity and improved health outcomes in sedentary breast cancer survivors, with notable improvements in physical activity counts, muscle strength, and social well-being among the 41 participants studied.

While the intervention showed positive effects, it also led to increased reports of joint stiffness, indicating the need for careful monitoring of side effects in future larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial to increase physical activity in breast cancer survivors. Rogers, LQ., Hopkins-Price, P., Vicari, S., et al.[2009]

Physical activity has been shown to significantly improve both patient-reported outcomes and physiological health in cancer survivors during and after treatment, highlighting its importance in recovery.

The review discusses ongoing phase III trials that are investigating the impact of physical activity on clinical disease endpoints, suggesting a strong focus on integrating exercise into cancer care to enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Putting Exercise Into Oncology Practice: State-of-the-Science, Innovation, and Future Directions. Brown, JC., Ligibel, JA.[2023]

Physical activity is linked to a lower risk of developing breast cancer and recurrence, as well as improved survival rates, based on observational studies.

Engaging in physical activity can alleviate treatment-related side effects, such as fatigue from chemotherapy and musculoskeletal issues from aromatase inhibitors, highlighting its importance in breast cancer survivorship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity and Breast Cancer: an Opportunity to Improve Outcomes. Peterson, LL., Ligibel, JA.[2019]

A 12-week physical activity intervention for obese endometrial cancer survivors showed significant improvements in physical function, waist circumference, and quality of life, with large effect sizes compared to a control group.

Despite low recruitment rates, the intervention was feasible, with a majority of participants attending most sessions and reporting increased physical activity, indicating potential for further research in larger trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a physical activity intervention for obese, socioculturally diverse endometrial cancer survivors. Rossi, A., Garber, CE., Ortiz, M., et al.[2017]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12409339/

Telehealth Approach in Breast Cancer Care: A Systematic ... Based on a recent meta-analysis, telehealth-based interventions are effective in reducing psychological symptoms such as depression and stress ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3698870/

An Intervention to Improve Communication Between Breast ... In the current study, we sought to increase survivors' self-efficacy in managing their cancer by coaching them to express their concerns directly to their ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04262180

Physical Activity Promotion for Breast and Endometrial ... Many breast and endometrial cancer survivors do not get enough physical activity. Technology-based interventions can be inexpensive and easy to scale up, ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2214782925000478

Evidence-based digital health interventions for breast ... Physical activity is the most studied outcome in breast cancer survivors. •. eHealth interventions can improve physical activity in breast cancer survivors. •.

5. cancer.jmir.org cancer.jmir.org/2021/4/e31966/

A Digital Coaching Intervention for Cancer Survivors With Job ... For example, large cohort studies have shown that approximately 60% of cancer survivors successfully return to work at 1 to 2 years after a ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7486982/

Wellness Coaching Intervention for Increasing Healthy ... The 20 breast cancer survivors demonstrated 100% adherence to the initial wellness coaching visit and 96% adherence to the 4 telephone calls.

7. ijbnpa.biomedcentral.com ijbnpa.biomedcentral.com/articles/10.1186/s12966-024-01561-2

Effects of remote coaching following supervised exercise ... This study aimed to assess the effectiveness of a six-month remote coaching intervention, following a supervised exercise oncology rehabilitation program on ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8663674/

A Digital Coaching Intervention for Cancer Survivors With Job ... This study sought to evaluate return-to-work outcomes of a multidisciplinary intervention provided as routine employee support.