ActivityChoice: Implementing Clinic-Based Physical Activity Program Choices for Cancer Survivors

Study Overview
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Brief Summary
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Cardiovascular disease, the number one leading cause of death in the United States, is highly prevalent in cancer survivors. Physical activity can reduce risk, and referrals to programs addressing survivors' choices are highly recommended from providers in cancer survivorship, though rarely implemented. The study team proposes to develop ActivityChoice, a clinic-based implementation program, using patient narrative decision aids to support choices to a group in-person, group virtual, or self-monitored digital health physical activity program.

Official Title
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ActivityChoice: A Clinic-delivered Implementation Program to Increase Physical Activity and Decrease Cardiovascular Disease Risk Amongst Cancer Survivors

Conditions
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Cancer, Cardiovascular Diseases, Physical Inactivity

Intervention / Treatment
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* Behavioral: Enhanced Referral
* Behavioral: Standard Referral


Participation Criteria
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Eligibility Criteria
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AIM 1 Inclusion Criteria for Aim 1a Prior cancer diagnosis 18 years of age and older Speaks English Exclusion Criteria for Aim 1a No prior cancer diagnosis Under 18 years of age Prisoners Does not speak English AIM1B Survivor Inclusion Criteria for Aim 1b Prior cancer diagnosis 18 years of age and older Speaks English Survivor Exclusion Criteria for 1b No prior cancer diagnosis Under 18 years of age Does not speak English Prisoners Participated in Aim 1a Clinic Staff Inclusion Criteria for Aim 1b Provide cancer care for patients at one of the four UMass cancer clinics, Involved in survivorship care planning visits Speaks English 18 years of age and older Clinic Staff Exclusion Criteria for 1b Is not employed at one of the four UMass cancer clinics Is not involved in survivorship care planning visits Does not speak English Prisoners Under 18 years of age Pregnant Women Pregnant women may be included in this study as an incidental population. AIM 2 Clinic Staff Inclusion Criteria for Aim 2 Provide cancer care for patients at one of the four UMass cancer clinics Involved in survivorship care visits Speaks English 18 years of age and older Clinic Staff Exclusion Criteria for Aim 2 Is not employed at one of the four UMass cancer clinics Is not involved in survivorship care visits Does not speak English Prisoners Under 18 years of age Survivor Inclusion Criteria for Aim 2 Cancer Patient at one of the four UMass cancer clinics Has a survivorship care planning visit Able to perform physical activity Completes Physical Activity Readiness Questionnaire (PAR-Q) physical activity readiness questionnaire or has medical clearance to participate Has a smartphone Speaks English 18 years of age and older Survivor Exclusion Criteria for Aim 2: Not a cancer patient at one of the four UMass cancer clinics Does not have a survivorship care planning visit Unable to perform physical activity or no medical clearance to participate Does not speak English Under 18 years of age Does not have a smartphone Prisoners Is pregnant AIM 3 Clinic Staff Inclusion Criteria for Aim 3 Are enrolled in ActivityChoice ≥ 18 years of age Provide written informed consent Patient Inclusion Criteria for Aim 3 Are enrolled in ActivityChoice Had a clinic visit with one of the enrolled clinic staff during the study period ≥ 18 years of age Speaks English Provide written informed consent Patient Exclusion Criteria for Aim 3 Not enrolled in ActivityChoice Was not seen in the clinic by an enrolled clinic staff during the study period UMass Cancer Clinic Administration Inclusion Criteria for Aim 3 Are ≥ 18 years of age Are in positions of cancer center leadership Provide written informed consent UMass Cancer Clinic Administration Exclusion Criteria for Aim 3 Unable or unwilling to provide written informed consent Not in positions of leadership within the UMass Medical Cancer Clinic Administration <18 years of age. External site stakeholders Inclusion Criteria for Aim 3 Are ≥18 years of age Are in positions of cancer center leadership Provide written informed consent. External site stakeholders Exclusion Criteria for Aim 3 Unable or unwilling to provide written informed consent Not in positions of leadership overseeing cancer survivorship <18 years of age.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Stepped-wedge sequential crossover design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Referral<br>Provider education/training on referral process Patient education material on physical activity benefits Paper referral to LIVESTRONG at the YMCA Fitbit Activity Monitor | Behavioral: Standard Referral<br>* The standard referral period will serve as the usual care comparator. Patients will receive a paper referral and Fitbit monitor.<br>|
| Experimental: Enhanced Referral<br>Provider education/training on referral process Patient education material on physical activity benefits Patient decision aid on physical activity program choices Electronic referral to program of patient's choice Fitbit Activity Monitor | Behavioral: Enhanced Referral<br>* The enhanced referral uses an electronic referral and patient decision aid to provide choices to 3 different physical activity programs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients referred as obtained by the electronic referral system and electronic health record | The number of patients referred/The number of eligible patients | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of eligible clinicians enrolling in the the study | Number of enrolled clinicians/Number of eligible clinicians | Baseline | 
| Clinic/Clinician fidelity of delivering patient decision aids | Clinic delivery of patient decision aids as reported by patients | Baseline | 
| Patient Engagement | Program enrollment (number referred/number enrolled); | Examined at baseline, 3-, and 6-months | 
| Patient Retention | Percent of enrolled patients completing follow-up surveys at 3- and 6-months | 3- and 6-months | 
| Patient narrative decision aid acceptability and effectiveness (Enhanced Referral only) | Acceptability of decision aid using the Ottawa Decision Aid Centre 10-item acceptability of decision aids (Minimum score=0, Maximum score=100; Higher score indicates higher decisional conflict and uncertainty | Baseline following referrals | 
| Patient Autonomous Regulation | Behavioral Regulation for Exercise Questionnaire-2 (Minimum=0, Maximum=76; Higher scores indicates greater regulation/motivation) | Baseline, 3- and 6-months | 
| Patient Objective Physical Activity | Change from baseline to 3- and 6-months in steps, light, moderate and vigorous physical activity measured via Fitbits. | Baseline, 3- and 6-months | 
| Patient Self-Report Physical Activity | Change from baseline to 3- and 6-months in light, moderate and vigorous physical activity survey-measured (Godin leisure time questionnaire) physical activity. The questionnaire is a 4-item self-administered questionnaire with the first three questions seeking information on the number of times one engages in mild, moderate and strenuous leisure-time physical activity bouts of at least 15 min duration in a typical week. Scores can range from 0 to 98, with the higher score meaning a greater level of activity for that week. | Baseline, 3- and 6-months | 
| Patient Health-related Quality of Life | Functional Assessment of Cancer Therapy-General (FACT-G): Physical, social, emotional and functional well-being (Minimum=0, Maximum=127; Higher score means a higher quality of life) | Baseline, 3- and 6-months |