Clinical trial NCT04262180: Physical Activity Promotion for Breast and Endometrial Cancer Survivors
Official title: Multi-site Adaptive Trial of a Technology-based, EHR-integrated Physical Activity Intervention in Breast and Endometrial Cancer Survivors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Physical Activity
Breast Cancer Survivors
Endometrial Cancer Survivors
Keywords: MVPA
Fitbit
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Northwestern University
name: National Cancer Institute (NCI)
First posted: 2020-02-10
Enrollment: 323
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: There are 3,000,000 breast and 760,000 endometrial cancer survivors in the US and these populations will grow 30% by 2026. Increased moderate-to-vigorous intensity physical activity (MVPA) is consistently associated with enhanced quality of life, reduced chronic disease risk, and improved cancer prognosis in these survivors yet 70-90% fail to engage in the 150 minutes/week of MVPA recommended by the American Cancer Society. Unfortunately, since physical activity support is not a part of standard survivorship care, few survivors have access to efficacious MVPA interventions. A key barrier to translation of MVPA promotion into care is the design of existing programs, which are resource-intensive, costly, and deliver multiple components (i.e., coaching calls, supervised exercise) simultaneously to all participants. This "one-size-fits-all" approach does not account for individual needs, nor can it realistically be implemented into care. Thus there is a critical need for effective, scalable interventions that efficiently allocate resources to meet each woman's needs.

An adaptive approach that tries minimal, low resource treatments (i.e., technology tools) for everyone first, and reserves the use of higher-resource components (e.g., coaching) for survivors who fail to increase MVPA, offers a promising alternative to traditional approaches. This engages women who lack the time or transportation to participate in more intensive interventions, yet avoids providing high-resource components to those who would respond well to a lower-dose intervention. Success with integrating Fitbit MVPA data into the electronic health record (EHR) with the capability to provide weekly progress feedback to participants via the EHR's patient portal represents a relatively low resource (vs. coaching or supervised exercise) and potentially efficacious minimal intervention that could be augmented as needed. Placement of the intervention within the EHR is a major advance because it communicates that MVPA is central to survivors' health and is a priority of the cancer care team. Clinicians can be engaged to ensure the intervention is viewed as integral to survivorship care with minimal burden by referring patients to an EHR-based intervention, endorsing intervention messages delivered via the EHR and reviewing a patient's progress at their clinic visits using simple EHR alerts.

While the Fitbit plus EHR integration (Fitbit+EHR) minimal intervention will be sufficient for some survivors to increase their MVPA, others will need more support. Little data exists to determine what strategies would be most effective for augmenting a minimal intervention. Further, it is unknown how long the minimal intervention should be continued before augmentations are used. Some survivors may need more support early on, while others may initially succeed but later fail as the weekly MVPA goal increases. Still others may falter initially and recover.

This project uses an innovative adaptive experimental approach, to determine the optimal augmentation tactics to the minimal (Fitbit+EHR) MVPA intervention in inactive breast and endometrial cancer survivors (n=320). All women will receive the Fitbit+EHR intervention. Those who do not respond (meet ≤80% of MVPA goal over previous 4 weeks) will be randomized to one of two more intensive augmentation tactics using technology, alone, or in combination with a more traditional component: (1) online gym with access to exercise videos or (2) coaching calls. Participants in the minimal intervention will be evaluated for non-response every 4 weeks so augmentation is delivered when they lapse. Responders will continue with the minimal intervention. The primary outcome is accelerometer-measured weekly minutes of MVPA at 6 months, 12 months, and 30 months. The investigator will also examine the effects of the intervention sequences on symptom burden and functional performance, important indicators of morbidity in these populations.

This is the first systematic effort to develop an adaptive MVPA intervention in any cancer population. Knowledge gained from this study will inform the development of effective, scalable clinic-based interventions to improve quality of life and reduce disease burden among breast and endometrial cancer survivors.

\[Protocol Amendment approved on 5/24/2023 added a 30 month time point to data collection.\]

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in the 'Weekly minutes of moderate- to-vigorous physical activity (MVPA)' as measured by actigraph
timeFrame: Baseline, 6 months, 12 months, 30 months
measure: Change in the 'Weekly minutes of MVPA' as measured by Fitbit
timeFrame: Baseline, 6 months, 12 months, 30 months
measure: Change in the 'Weekly minutes of MVPA' as reported in Self-report
timeFrame: Baseline, 6 months, 12 months, 30 months
measure: Godin Leisure Time Exercise Questionnaire (GLTEQ) score
timeFrame: 12 months and 30 months
measure: Change in the 'Sitting time per week'
timeFrame: Baseline, 6 month, 12 month, 30 months
Secondary outcomes:
measure: Short Physical Performance Battery (SPB) score
timeFrame: Baseline, 6 months, 12 months, 30 months
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) short form score for physical function
timeFrame: Baseline, 6 months, 12 months, 30 months
measure: Change in PROMIS short form score for fatigue
timeFrame: Baseline, 6 months, 12 months, 30 months
measure: Change in PROMIS short form score on Sleep Related Impairment
timeFrame: Baseline, 6 months, 12 months, 30 months
measure: Change in PROMIS short form score on Sleep Disturbance
timeFrame: Baseline, 6 months, 12 months, 30 months
measure: Change in PROMIS short form score on Applied Cognition-Abilities
timeFrame: Baseline, 6 months, 12 months, 30 months
measure: Change in PROMIS short form score for Emotional Distress - Anxiety
timeFrame: Baseline, 6 months, 12 months, 30 months
measure: Change in PROMIS short form score for Depression
timeFrame: Baseline, 6 months, 12 months, 30 months
measure: Change in PROMIS short form score for Emotional Support
timeFrame: Baseline, 6 months, 12 months, 30 months
measure: Change in FACT-B Quality of Life Survey
timeFrame: Baseline, 6 months, 12 months, 30 months
measure: Change in FACT-En Quality of Life Survey
timeFrame: Baseline, 6 months, 12 months, 30 months
Other outcomes:
measure: Social Cognitive Theory (SCT) constructs : Exercise Self-Efficacy Scale
timeFrame: 12 months
measure: SCT constructs : Barriers specific Self-Efficacy scale
timeFrame: 12 months
measure: SCT constructs : Physical activity enjoyment scale
timeFrame: 12 months
measure: SCT constructs : Exercise goal setting scale
timeFrame: 12 months
measure: Social Cognitive Theory (SCT) constructs :Multidimensional Outcome Expectations for Exercise Scale(MOESS)
timeFrame: 12 months
measure: Social Cognitive Theory (SCT) constructs : Social Support for Exercise Scale
timeFrame: 12 months
measure: Intervention implementation and fidelity: Fitbit wear time per week
timeFrame: up to 12 months
measure: Intervention implementation and fidelity: number of read/unread emails
timeFrame: up to 6 months
measure: Intervention implementation and fidelity: Number of feedback emails delivered via the EHR's patient portal
timeFrame: up to 12 months
measure: Intervention implementation and fidelity: Time spent in watching online gym exercise videos
timeFrame: up to 12 months
measure: HINTS Questionnaire
timeFrame: Baseline, 6 months, 12 months
measure: Participant Program Evaluation
timeFrame: up to 12 months
measure: Clinician Questionnaire
timeFrame: Baseline, 6 months, 12 months (and every 6 months thereafter until data collection is complete)
measure: Change in Virtual Functional Performance Testing Feedback Survey
timeFrame: Baseline, 6 months, 12 months
Locations:
city: Chicago
country: United States
facility: Department of Preventative Medicine, Northwestern University
state: Illinois
city: Madison
country: United States
facility: Department of Kinesiology, University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Kristen Pickett, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University, Chicago
name: Siobhan Phillips, Ph.D., MPH
role: PRINCIPAL_INVESTIGATOR
References: