Physical ActivityNCT04262180
Physical Activity Promotion for Breast and Endometrial Cancer Survivors
A study testing Base intervention-Fitbit with EHR integration, Coaching Calls and Online Gym in people with Physical Activity and Breast Cancer Survivors, run by University of Wisconsin, Madison at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Physical Activity, Breast Cancer Survivors, Endometrial Cancer Survivors
- What is being tested?
- Base intervention-Fitbit with EHR integration, Coaching Calls and Online Gym
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 323 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Nov 2020to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Department of Preventative Medicine, Northwestern University
Chicago, Illinois, 60611
Department of Kinesiology, University of Wisconsin
Madison, Wisconsin, 53706
About this study
Official title: Multi-site Adaptive Trial of a Technology-based, EHR-integrated Physical Activity Intervention in Breast and Endometrial Cancer Survivors
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.
Read the 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.]
- Being tested
- Base intervention-Fitbit with EHR integration, Coaching Calls, Online Gym
- Keywords
- MVPA, Fitbit
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Base intervention-Fitbit with EHR integrationOther
Every subject will start with a base intervention - Fitbit activity tracker with EHR integration including messages delivered via the EHR's patient portal
Coaching CallsOther
Non-responders to base intervention will be randomized to coaching calls.
Online GymOther
Non-responders to base intervention will be randomized to online gym.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Base intervention-Fitbit with EHR integration; Other: Coaching Calls |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, 6 month, 12 month, 30 months
Secondary outcomes (11)
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).
Measured: Baseline, 6 months, 12 months, 30 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.
Measured: Baseline, 6 months, 12 months, 30 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
Measured: Baseline, 6 months, 12 months, 30 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.
Measured: Baseline, 6 months, 12 months, 30 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.
Measured: Baseline, 6 months, 12 months, 30 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
Measured: Baseline, 6 months, 12 months, 30 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.
Measured: Baseline, 6 months, 12 months, 30 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.
Measured: Baseline, 6 months, 12 months, 30 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.
Measured: Baseline, 6 months, 12 months, 30 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.
Measured: Baseline, 6 months, 12 months, 30 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.
Measured: Baseline, 6 months, 12 months, 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start9 Nov 2020
- Primary completion15 Sep 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kristen Pickett, Ph.D., Principal investigator, University of Wisconsin, MadisonSiobhan Phillips, Ph.D., MPH, Principal investigator, Northwestern University, Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04262180
- Sponsor's protocol ID
- 2018-1361
- Other IDs
- EDUC/KINESIOLOGY/KINESIOLOG, 1R37CA225877-01A1, A176000, UW18094, Protocol Version 2/22/2024, NCI-2020-00400
- Status last verified
- Oct 2025
- First submitted
- 6 Feb 2020
- Last updated
- 24 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37086916
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-site Adaptive Trial of a Technology-based, EHR-integrated Physical Activity Intervention in Breast and Endometrial Cancer Survivors
- ClinicalTrials.gov ID
- NCT04262180
- Acronym / sponsor ID
- 2018-1361
- Keywords
- MVPA, Fitbit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Northwestern University, National Cancer Institute (NCI)
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 10 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.]
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Base intervention- Fitbit with EHR integration | Experimental | Other: Base intervention-Fitbit with EHR integrationAll 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. |
| Nonresponders -Stepped up to Online gym | Experimental | Other: Base intervention-Fitbit with EHR integration, Other: Online GymNon-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. |
| Nonresponders -Stepped up to Coaching calls | Experimental | Other: Base intervention-Fitbit with EHR integration, Other: Coaching CallsNon-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Base intervention-Fitbit with EHR integrationEvery subject will start with a base intervention - Fitbit activity tracker with EHR integration including messages delivered via the EHR's patient portal | Other | Base intervention- Fitbit with EHR integration, Nonresponders -Stepped up to Coaching calls, Nonresponders -Stepped up to Online gym |
| Coaching CallsNon-responders to base intervention will be randomized to coaching calls. | Other | Nonresponders -Stepped up to Coaching calls |
| Online GymNon-responders to base intervention will be randomized to online gym. | Other | Nonresponders -Stepped up to Online gym |
Primary outcome
Change in the 'Weekly minutes of moderate- to-vigorous physical activity (MVPA)' as measured by actigraph
Time frame: Baseline, 6 months, 12 months, 30 months
Change in the 'Weekly minutes of moderate- to-vigorous physical activity (MVPA)' as measured by actigraph
Change in the 'Weekly minutes of MVPA' as measured by Fitbit
Time frame: Baseline, 6 months, 12 months, 30 months
Change in the 'Weekly minutes of moderate- to-vigorous physical activity (MVPA)' as measured by Fitbit
Change in the 'Weekly minutes of MVPA' as reported in Self-report
Time frame: Baseline, 6 months, 12 months, 30 months
Change in the 'Weekly minutes of moderate- to-vigorous physical activity (MVPA)' as reported in Self-report
Godin Leisure Time Exercise Questionnaire (GLTEQ) score
Time frame: 12 months and 30 months
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
Change in the 'Sitting time per week'
Time frame: Baseline, 6 month, 12 month, 30 months
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
11 secondary outcomes
Short Physical Performance Battery (SPB) score
Time frame: Baseline, 6 months, 12 months, 30 months
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) short form score for physical function
Time frame: Baseline, 6 months, 12 months, 30 months
Change in PROMIS short form score for fatigue
Time frame: Baseline, 6 months, 12 months, 30 months
Change in PROMIS short form score on Sleep Related Impairment
Time frame: Baseline, 6 months, 12 months, 30 months
Change in PROMIS short form score on Sleep Disturbance
Time frame: Baseline, 6 months, 12 months, 30 months
Change in PROMIS short form score on Applied Cognition-Abilities
Time frame: Baseline, 6 months, 12 months, 30 months
Change in PROMIS short form score for Emotional Distress - Anxiety
Time frame: Baseline, 6 months, 12 months, 30 months
Change in PROMIS short form score for Depression
Time frame: Baseline, 6 months, 12 months, 30 months
Change in PROMIS short form score for Emotional Support
Time frame: Baseline, 6 months, 12 months, 30 months
Change in FACT-B Quality of Life Survey
Time frame: Baseline, 6 months, 12 months, 30 months
Change in FACT-En Quality of Life Survey
Time frame: Baseline, 6 months, 12 months, 30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2025.
- Derived from this study: PubMed 37086916Cadmus-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristen Pickett, Ph.D. principal investigator
University of Wisconsin, Madison
Siobhan Phillips, Ph.D., MPH principal investigator
Northwestern University, Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Base intervention-Fitbit with EHR integration, Coaching Calls and Online Gym in people with Physical Activity and Breast Cancer Survivors, run by University of Wisconsin, Madison at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the 'Weekly minutes of moderate- to-vigorous physical activity (MVPA)' as measured by actigraph (time frame: Baseline, 6 months, 12 months, 30 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04262180, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2025; AzTrials last refreshed its copy on 7 Nov 2026.