Physical Activity Promotion for Breast and Endometrial Cancer Survivors

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

323 Participants Needed

Trial Summary

What is the purpose of this trial?

Many breast and endometrial cancer survivors do not get enough physical activity. Technology-based interventions can be inexpensive and easy to scale up, however they are not effective for all women. The purpose of this study is test an adaptive physical activity intervention approach that reserves the most resources and support for women who do not fare well with a lower-cost, minimal intervention. The results from this trial will inform the development of scalable physical activity interventions for breast and endometrial cancer survivors.

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 data supports the effectiveness of the treatment Physical Activity Promotion for breast and endometrial cancer survivors?

Research shows that physical activity can improve physical functioning, reduce cancer-related symptoms, and enhance quality of life for cancer survivors. Observational studies suggest that high levels of physical activity may also improve survival outcomes, although more trials are needed to confirm this. ^{1 2 3 4 5}

Is physical activity promotion safe for cancer survivors?

Research shows that physical activity is generally safe for cancer survivors and can improve their quality of life and health. Studies have focused on breast and endometrial cancer survivors, indicating that physical activity interventions are feasible and beneficial. ^{3 5 6 7 8}

How does the treatment of physical activity promotion differ from other treatments for breast and endometrial cancer survivors?

Physical activity promotion is unique because it focuses on improving health and quality of life through exercise rather than medication. It aims to increase physical activity levels, which can help reduce the risk of cancer recurrence and improve overall well-being, especially for those who are sedentary or have obesity. ^{3 4 7 9 10}

Research Team

Kristen Pickett, Ph.D.

Principal Investigator

University of Wisconsin, Madison

Siobhan Phillips, Ph.D., MPH

Principal Investigator

Northwestern University, Chicago

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Mortality risk and physical activity across the lifespan in endometrial cancer survivors. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The role of physical activity in breast and gynecologic cancer survivorship. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Feasibility of a physical activity intervention for obese, socioculturally diverse endometrial cancer survivors. [2017]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Perceptions of a comprehensive physical activity behavior intervention among endometrial cancer survivors with obesity. A qualitative study. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

Physical Activity and Breast Cancer: an Opportunity to Improve Outcomes. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

A randomized trial to increase physical activity in breast cancer survivors. [2009]

8. United States pubmed.ncbi.nlm.nih.gov

A qualitative synthesis of trials promoting physical activity behaviour change among post-treatment breast cancer survivors. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Exercise preferences of endometrial cancer survivors: a population-based study. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Cancer-related impairments influence physical activity in uterine cancer survivors. [2022]