Physical Activity Clinical Trial
Official title:
Multi-site Adaptive Trial of a Technology-based, EHR-integrated Physical Activity Intervention in Breast and Endometrial Cancer Survivors
Verified date | March 2024 |
Source | University of Wisconsin, Madison |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 323 |
Est. completion date | January 31, 2026 |
Est. primary completion date | August 1, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Department of Preventative Medicine, Northwestern University | Chicago | Illinois |
United States | Department of Kinesiology, University of Wisconsin | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison | National Cancer Institute (NCI), Northwestern University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Social Cognitive Theory (SCT) constructs : Exercise Self-Efficacy Scale | Self-efficacy will be assessed using the Exercise Self-Efficacy Scale which assess the beliefs of participants to be able to exercise in the future.
Scale consists of 6 questions which are graded from 0-100% in gradation of 10. 0% correlates to 'not at all confident' whereas 100% means highly confident in continuing their exercise. |
12 months | |
Other | SCT constructs : Barriers specific Self-Efficacy scale | Self-efficacy will be assessed using the Barriers Self-Efficacy Scale which assess the beliefs in ability to be active over the next 12 weeks, despite common barriers.
Items in the scale reflect situations which can be common reasons for preventing participants from actively exercising or, in some cases, dropping out. Scale has 13 questions which are graded from 0-100% in gradation of 10. 0% correlates to 'not at all confident' whereas 100% means Highly confident in continuing their exercise in the situations listed in the questionnaire. Scores can range from 0-1300 where higher scores means more adherence to the exercise regime in the event of unfavorable conditions. |
12 months | |
Other | SCT constructs : Physical activity enjoyment scale | Physical Activity Enjoyment Scale which assesses level of enjoyment and satisfaction with current MVPA program will be used to measure facilitators/barriers.
The scale consists of 18 questions which can be answered on a scale of 1-7(I enjoy it- I hate it). The cumulative score ranges from 18-126 where higher scores means participant is not enjoying the physical activity. |
12 months | |
Other | SCT constructs : Exercise goal setting scale | The Exercise Goal Setting Scale will assess MVPA-related exercise goal-setting. Questionnaire contains 10 questions which can be answered in the grading of 'Does not describe'/ 'Describe moderately'/ 'Describe completely'. Based on the response score on the exercise goal setting scale can range from 10-50. Higher scores correlates to firmer exercise goals. | 12 months | |
Other | Social Cognitive Theory (SCT) constructs :Multidimensional Outcome Expectations for Exercise Scale(MOESS) | MOESS is used to assess three related, but conceptually independent domains of outcome expectations for exercise (i.e., physical, social, and self-evaluative outcome expectations). For each item, participants indicate the degree to which they agree with each statement.
The scale consists of 20 questions which can be answered as 1-Strongly agree, 2-Disagree, 3-Neutral, 4-Agree, 5-Strongly agree. Higher scores correlates to higher outcome expectation for exercise. |
12 months | |
Other | Social Cognitive Theory (SCT) constructs : Social Support for Exercise Scale | The Social Support for Exercise Scale which assesses support for MVPA received from friends, family and other survivors.
Scale contains 10 questions which can be answered as:1-Never, 2-Rarely, 3-A few times, 4-Often, 5-Very Often, 8-Does not apply. Scale includes separate categories for support by Family, Friends and Other survivors. Applicable scores can range from 10-50. Higher scores(max 50 in the applicable range) in each category correlates to stronger social support for exercise from that group. |
12 months | |
Other | Intervention implementation and fidelity: Fitbit wear time per week | Intervention implementation and fidelity: Fitbit wear time per week | up to 12 months | |
Other | Intervention implementation and fidelity: number of read/unread emails | Status of feedback emails delivered via the EHR's patient portal will be measures as number of read/unread emails | up to 6 months | |
Other | Intervention implementation and fidelity: Number of feedback emails delivered via the EHR's patient portal | Intervention implementation and fidelity: Number of feedback emails delivered via the EHR's patient portal | up to 12 months | |
Other | Intervention implementation and fidelity: Time spent in watching online gym exercise videos | Intervention implementation and fidelity: Time spent in watching online gym exercise videos | up to 12 months | |
Other | HINTS Questionnaire | The Health Information National Trends Survey (HINTS) will be used in part to measure the intervention implementation and fidelity. HINTS collects nationally representative data routinely about the American public's use of cancer-related information. It is a 30-item multiple choice survey about medical research and medical records and patient-provider communications. | Baseline, 6 months, 12 months | |
Other | Participant Program Evaluation | The participant program evaluation is designed to get feedback from participants. It contains multiple different question types across 16-items about the intervention, and 7-items about the coaching calls, and 17-items about the online gym experience. | up to 12 months | |
Other | Clinician Questionnaire | The clinician questionnaire surveys clinicians about their experience with the intervention. This questionnaire contains a variety of questions on different 5 point likert scales as well as open ended queries for feedback on the intervention. | Baseline, 6 months, 12 months (and every 6 months thereafter until data collection is complete) | |
Other | Change in Virtual Functional Performance Testing Feedback Survey | The Virtual Functional Performance Testing Feedback Survey includes a mixture of multiple choice and free response (6 items), and 5 point likert items (15 items). It is intended as a feedback measure from participants in response to the virtual aspects of this intervention. | Baseline, 6 months, 12 months | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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, 30 months | |
Secondary | 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, 30 months | |
Secondary | 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, 30 months | |
Secondary | 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, 30 months | |
Secondary | 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, 30 months | |
Secondary | 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, 30 months | |
Secondary | 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, 30 months | |
Secondary | 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, 30 months | |
Secondary | 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, 30 months | |
Secondary | 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, 30 months | |
Secondary | 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, 30 months |
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