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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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 outcome measures

Change in Virtual Functional Performance Testing Feedback Survey

Clinician Questionnaire

HINTS Questionnaire

+11 more

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

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor

1,182 Previous Clinical Trials

3,167,064 Total Patients Enrolled

Northwestern UniversityOTHER

1,585 Previous Clinical Trials

916,908 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,932,830 Total Patients Enrolled

Media Library

Physical Activity Promotion Clinical Trial Eligibility Overview. Trial Name: NCT04262180 — N/A

Physical Activity Research Study Groups: Base intervention- Fitbit with EHR integration, Nonresponders -Stepped up to Online gym, Nonresponders -Stepped up to Coaching calls

Physical Activity Clinical Trial 2023: Physical Activity Promotion Highlights & Side Effects. Trial Name: NCT04262180 — N/A

Physical Activity Promotion 2023 Treatment Timeline for Medical Study. Trial Name: NCT04262180 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this study still available to prospective participants?

"Affirmative, the information posted to clinicaltrials.gov confirms that this scientific inquiry is actively recruiting participants. The trial was first published on September 8th 2020 and most recently updated October 4th 2021. Currently, 320 candidates are being sought from 2 distinct medical sites."

Answered by AI

To what extent is this clinical trial populated by participants?

"That is correct. Clinicaltrials.gov points out that this research effort, which was posted on September 8th 2020, is actively seeking participants. About 320 patients need to be acquired from 2 distinct sites."

Answered by AI

What goals are the researchers hoping to accomplish with this research?

"This medical study, to be evaluated at Baseline, 6 months and 12 months, has two primary objectives: measurement of the Godin Leisure Time Exercise Questionnaire (GLTEQ) score; as well as tracking changes in PROMIS Short Form scores for Depression, Sleep Related Impairment and a Short Physical Performance Battery. The latter three all rely on a 5-point scale ranging from 8 to 40 with higher numbers indicating more severe outcomes."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Physical Activity Promotion for Breast and Endometrial Cancer Survivors

2020. "Physical Activity Promotion for Breast and Endometrial Cancer Survivors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04262180.

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