Physical Activity Promotion for Breast and Endometrial Cancer Survivors

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Our 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 efficacious16-19 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. Thus, this project uses an innovative adaptive experimental approach, to determine the optimal augmentation tactics to our 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. 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.

Official Title
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Multi-site Adaptive Trial of a Technology-based, EHR-integrated Physical Activity Intervention in Breast and Endometrial Cancer Survivors

Conditions
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Physical Activity, Breast Cancer Survivors, Endometrial Cancer Survivors

Intervention / Treatment
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* Other: Base intervention-Fitbit with EHR integration
* Other: Coaching Calls
* Other: Online Gym


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: one control arm, two randomized arms. every subject starts with a base intervention, non-responders will be randomized to one of the two arms.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Base intervention- Fitbit with EHR integration<br>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<br>* Every subject will start with a base intervention - Fitbit activity tracker with EHR integration including messages delivered via the EHR's patient portal<br>|
| Experimental: Nonresponders -Stepped up to Online gym<br>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<br>* Every subject will start with a base intervention - Fitbit activity tracker with EHR integration including messages delivered via the EHR's patient portal<br>Other: Online Gym<br>* Non-responders to base intervention will be randomized to online gym.<br>|
| Experimental: Nonresponders -Stepped up to Coaching calls<br>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<br>* Every subject will start with a base intervention - Fitbit activity tracker with EHR integration including messages delivered via the EHR's patient portal<br>Other: Coaching Calls<br>* Non-responders to base intervention will be randomized to coaching calls.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 and 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Physical Performance Battery (SPB) score | Participants will complete the Short Physical Performance Battery (SPB), a well-validated physical function performance measure. This battery assesses lower extremity function in adults. The SPB score is based on timed measures of gait speed, ability to rise from a chair, and standing balance. Gait speed will be measured using the better of two recorded times over a 4-meter course. Chair stand time will be measured as the time needed to rise five times from a seated position in a chair, with arms folded across the chest. For the balance test, participants will be asked to maintain their feet side-by-side, semi-tandem, and tandem positions for 10 seconds each. Each individual performance measure will be scored according to established cutpoints and aggregated for a total SPB score. Total SPB score range: 0 (worst performance) to 12 (best performance). | Baseline, 6 months, 12 months | 
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) short form score for physical function | The PROMIS short forms are self-report instruments used to measure aspects of quality of life that are known to be common long-lasting symptoms after cancer treatment. At each time point, participants will complete PROMIS short form measures for physical function.The functional performance tests are in-person tests that assess physical abilities (strength, mobility) in ways that are relevant to daily living. PROMIS measures are measured on T-score metrics. The short form consists of 20 questions which can be answered on a scale of 1-5 where 1-Unable to do, 2-with much difficulty, 3-with some difficulty,4-with a little difficulty, 5- without any difficulty. The cumulative score ranges from 20 to 100, where higher scores correlates to more physically active person. | Baseline, 6 months, 12 months | 
| Change in PROMIS short form score for fatigue | The PROMIS short forms are self-report instruments used to measure aspects of quality of life that are known to be common long-lasting symptoms after cancer treatment. The functional performance tests are in-person tests that assess physical abilities in ways that are relevant to daily living. Fatigue short form has 8 items. Each item on the measure is rated on a 5-point scale( 1-Not at all, 2-A little bit, 3-Somewhat, 4-Quite a bit, 5-Very much) with a range in score from 8 to 40 with higher scores indicating more fatigue | Baseline, 6 months, 12 months | 
| Change in PROMIS short form score on Sleep Related Impairment | The PROMIS short forms are self-report instruments used to measure aspects of quality of life that are known to be common long-lasting symptoms after cancer treatment. The functional performance tests are in-person tests that assess physical abilities in ways that are relevant to daily living. Sleep related impairment short form has 8 items. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater sleep disturbance. | Baseline, 6 months, 12 months | 
| Change in PROMIS short form score on Sleep Disturbance | The PROMIS short forms are self-report instruments used to measure aspects of quality of life that are known to be common long-lasting symptoms after cancer treatment. The functional performance tests are in-person tests that assess physical abilities in ways that are relevant to daily living. PROMIS sleep disturbance short form has 8 items. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance. | Baseline, 6 months, 12 months | 
| Change in PROMIS short form score on Applied Cognition-Abilities | The PROMIS short forms are self-report instruments used to measure aspects of quality of life that are known to be common long-lasting symptoms after cancer treatment. The functional performance tests are in-person tests that assess physical abilities in ways that are relevant to daily living. Applied Cognition-Abilities short form has 8 items. Each item on the measure is rated on a 5-point scale (1-Very much; 2-Quite a bit; 3-Somewhat; 4-A little bit, 5-Not at all) with a range in score from 8 to 40. Higher score correlates to higher cognitive ability | Baseline, 6 months, 12 months | 
| Change in PROMIS short form score for Emotional Distress - Anxiety | The PROMIS short forms are self-report instruments used to measure aspects of quality of life that are known to be common long-lasting symptoms after cancer treatment. The functional performance tests are in-person tests that assess physical abilities in ways that are relevant to daily living. Emotional Distress- Anxiety has 7 items. Each item on the measure is rated on a 5-point scale (1-never; 2-rarely; 3-sometimes. 4-often; 5-always) with a range in score from 7 to 35 with higher scores indicating greater severity of anxiety. | Baseline, 6 months, 12 months | 
| Change in PROMIS short form score for Depression | The PROMIS short forms are self-report instruments used to measure aspects of quality of life that are known to be common long-lasting symptoms after cancer treatment. The functional performance tests are in-person tests that assess physical abilities in ways that are relevant to daily living. PROMIS short form for Depression has 8 items. Each item on the measure is rated on a 5-point scale (1-never, 2-rarely, 3-sometimes; 4-often, 5-always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression. | Baseline, 6 months, 12 months | 
| Change in PROMIS short form score for Emotional Support | PROMIS Emotional Support scale is an 8-item scale. Individual items are scored from 1-5. The total range of possible overall raw scores is 8-40. These are then translated to T-scores using a table provided by PROMIS. The possible range of T-scores is 24.7-63.5. Emotional support may predict the adherence to the intervention. | Baseline, 6 months, 12 months | 
| Change in FACT-B Quality of Life Survey | The Functional Assessment of Cancer Therapy - Breast (FACT-B) Quality of Life Survey is a 37-item survey scored on a 5-point likert scale where 0 is 'not at all' to 4 is 'very much'. The total possible range of scores is 0-148 where lower scores indicate improved quality of life. | Baseline, 6 months, 12 months | 
| Change in FACT-En Quality of Life Survey | The Functional Assessment of Cancer Therapy - Endometrial (FACT-En) Quality of Life Survey is a 43-item survey scored on a 5-point likert scale where 0 is 'not at all' to 4 is 'very much'. The total possible range of scores is 0-172 where lower scores indicate improved quality of life. | Baseline, 6 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MVPA, Fitbit