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Physical Activity Promotion for Breast and Endometrial Cancer Survivors

N/A

Waitlist Available

Led By Lisa Cadmus-Bertram, Ph.D.

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 month, 12 month, 30 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new physical activity intervention for breast and endometrial cancer survivors that is tailored to each individual's stage of change, preferences, and barriers.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the intervention promotes physical activity through non-invasive means like fitness trackers and coaching calls, side effects are minimal but may include typical exercise-related risks such as muscle strain or fatigue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 month, 12 month, 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 month, 12 month, 30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 month, 12 month, 30 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in the 'Sitting time per week'

Change in the 'Weekly minutes of MVPA' as measured by Fitbit

Change in the 'Weekly minutes of MVPA' as reported in Self-report

+2 more

Secondary study objectives

Change in FACT-B Quality of Life Survey

Change in FACT-En Quality of Life Survey

Change in PROMIS short form score for Depression

+8 more

Other study objectives

Change in Virtual Functional Performance Testing Feedback Survey

Clinician Questionnaire

HINTS Questionnaire

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Nonresponders -Stepped up to Online gymExperimental Treatment2 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 callsExperimental Treatment2 Interventions

Group III: Base intervention- Fitbit with EHR integrationExperimental Treatment1 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.

Do I qualify?Apply below to find out