Physical Activity Promotion for Breast and Endometrial Cancer Survivors

NCT04262180 | Completed

• 7 other identifiers: 2018-1361EDUC/KINESIOLOGY/KINESIOLOG1R37CA225877-01A1A176000UW18094Protocol Version 2/22/2024NCI-2020-00400
• Study Type: interventional
• Target: 323
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Physical Activity; Breast Cancer Survivors; Endometrial Cancer Survivors

Keywords

MVPA; Fitbit

Outcome Measures

Primary Outcomes (5)

• Change in the 'Weekly minutes of moderate- to-vigorous physical activity (MVPA)' as measured by actigraph

  Change in the 'Weekly minutes of moderate- to-vigorous physical activity (MVPA)' as measured by actigraph

  Baseline, 6 months, 12 months, 30 months

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

  Change in the 'Weekly minutes of moderate- to-vigorous physical activity (MVPA)' as measured by Fitbit

  Baseline, 6 months, 12 months, 30 months

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

  Change in the 'Weekly minutes of moderate- to-vigorous physical activity (MVPA)' as reported in Self-report

  Baseline, 6 months, 12 months, 30 months

• Godin Leisure Time Exercise Questionnaire (GLTEQ) score

  Godin Leisure Time Exercise Questionnaire (GLTEQ) score measures the number of times on average a person does strenuous/moderate/mild exercise for more than 15 minutes during their leisure time. Weekly leisure activity score = (9 × Strenuous) + (5 × Moderate) + (3 × Light) GLTEQ Score Interpretation 24 units or more - Active 14 - 23 units - Moderately Active Less than 14 units - Insufficiently Active/Sedentary

  12 months and 30 months

• Change in the 'Sitting time per week'

  Although not a measure of physical activity, the Sitting Time Questionnaire will be administered at each of the three main data collection time points to provide context for the participant's inactive time. Less sitting time per week correlates to more physical activity

  Baseline, 6 month, 12 month, 30 months

Secondary Outcomes (11)

• Short Physical Performance Battery (SPB) score

  Baseline, 6 months, 12 months, 30 months

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) short form score for physical function

  Baseline, 6 months, 12 months, 30 months

• Change in PROMIS short form score for fatigue

  Baseline, 6 months, 12 months, 30 months

• Change in PROMIS short form score on Sleep Related Impairment

  Baseline, 6 months, 12 months, 30 months

• Change in PROMIS short form score on Sleep Disturbance

  Baseline, 6 months, 12 months, 30 months

Other Outcomes (14)

• Social Cognitive Theory (SCT) constructs : Exercise Self-Efficacy Scale

  12 months

• SCT constructs : Barriers specific Self-Efficacy scale

  12 months

• SCT constructs : Physical activity enjoyment scale

  12 months

Study Arms (3)

Base intervention- Fitbit with EHR integration

EXPERIMENTAL

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.

Other: Base intervention-Fitbit with EHR integration

Nonresponders -Stepped up to Online gym

EXPERIMENTAL

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.

Other: Base intervention-Fitbit with EHR integration; Other: Online Gym

Nonresponders -Stepped up to Coaching calls

EXPERIMENTAL

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.

Other: Base intervention-Fitbit with EHR integration; Other: Coaching Calls

Interventions

Base intervention-Fitbit with EHR integration OTHER

Every subject will start with a base intervention - Fitbit activity tracker with EHR integration including messages delivered via the EHR's patient portal

Base intervention- Fitbit with EHR integration; Nonresponders -Stepped up to Coaching calls; Nonresponders -Stepped up to Online gym

Coaching Calls OTHER

Non-responders to base intervention will be randomized to coaching calls.

Nonresponders -Stepped up to Coaching calls

Online Gym OTHER

Non-responders to base intervention will be randomized to online gym.

Nonresponders -Stepped up to Online gym

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female adult (≥18 years of age)
• Diagnosis of Stage I-III breast or Stage I-II Type 1 endometrial cancer within the past 5 years.
• At least 3 months past completion of primary active treatment (i.e., surgery, chemotherapy, and/or radiation). May still be undergoing endocrine or Human epidermal growth factor receptor 2 (Her2) therapies.
• 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.
• Able to access high-speed Internet daily at home on a computer, smartphone, or tablet. Internet access may be through a household connection or a wireless provider (e.g., Verizon, AT\&T). For compatibility with the Fitbit, the device must run a Windows, Apple, or Android operating system.
• Have a MyChart account or be willing to create one.
• Fluent in spoken and written English language.
• For safety, participants will be screened using the Physical Activity Readiness Questionnaire (PAR-Q) and the Falls Risk Screener, which address joint and cardiovascular problems, balance issues, and other concerns. Physician consent will be obtained for all participants who meet the following criteria:
• Answer yes to ≥1 question on the PAR-Q OR
• Answer yes to ≥4 questions on the Falls Risk Screener
• Willing and able to attend study visits at the University of Wisconsin, Madison or Northwestern University, Chicago
• Own and can use a smartphone

You may not qualify if:

• Any absolute contraindications to exercise (i.e. acute myocardial infarction, severe orthopedic conditions), metastatic disease or planned elective surgery during intervention/ follow-up.
• Self-reported difficulty transitioning walking 1 block (as a proxy measure of basic physical functioning), or inability to work towards the intervention goals
• Plans to become pregnant or to move from the area within the next two years
• Current enrollment in another dietary or physical activity trial

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Northwestern University: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Department of Preventative Medicine, Northwestern University

Chicago, Illinois, 60611, United States

Location

Department of Kinesiology, University of Wisconsin

Madison, Wisconsin, 53706, United States

Location

Related Publications (1)

• Cadmus-Bertram L, Solk P, Agnew M, Starikovsky J, Schmidt C, Morelli WA, Hodgson V, Freeman H, Muller L, Mishory A, Naxi S, Carden L, Tevaarwerk AJ, Wolter M, Barber E, Spencer R, Sesto ME, Gradishar W, Gangnon R, Spring B, Nahum-Shani I, Phillips SM. A multi-site trial of an electronic health integrated physical activity promotion intervention in breast and endometrial cancers survivors: MyActivity study protocol. Contemp Clin Trials. 2023 Jul;130:107187. doi: 10.1016/j.cct.2023.107187. Epub 2023 Apr 21.

  PMID: 37086916 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Kristen Pickett, Ph.D.

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

• Siobhan Phillips, Ph.D., MPH

  Northwestern University, Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Stratified randomization. Assessors will be blinded to which arm the participant is in.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One control arm and two randomized arms. Every participant starts with a base intervention, non-responders will be randomized to one of the two arms.

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 10, 2020
• Study Start: November 9, 2020
• Primary Completion: September 15, 2025
• Study Completion: September 15, 2025
• Last Updated: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)