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| ID | Type | Description | Link |
|---|---|---|---|
| 1K01HL163254 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Referral | Active Comparator | Provider education/training on referral process Patient education material on physical activity benefits Paper referral to LIVESTRONG at the YMCA Fitbit Activity Monitor |
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| Enhanced Referral | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced Referral | Behavioral | The enhanced referral uses an electronic referral and patient decision aid to provide choices to 3 different physical activity programs. |
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| 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 |
| 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 |
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AIM 1 Inclusion Criteria for Aim 1a
Exclusion Criteria for Aim 1a
AIM1B Survivor Inclusion Criteria for Aim 1b
Survivor Exclusion Criteria for 1b
Clinic Staff Inclusion Criteria for Aim 1b
Clinic Staff Exclusion Criteria for 1b
Pregnant Women Pregnant women may be included in this study as an incidental population.
AIM 2 Clinic Staff Inclusion Criteria for Aim 2
Clinic Staff Exclusion Criteria for Aim 2
Survivor Inclusion Criteria for Aim 2
Survivor Exclusion Criteria for Aim 2:
AIM 3 Clinic Staff Inclusion Criteria for Aim 3
Patient Inclusion Criteria for Aim 3
Patient Exclusion Criteria for Aim 3
UMass Cancer Clinic Administration Inclusion Criteria for Aim 3
UMass Cancer Clinic Administration Exclusion Criteria for Aim 3
External site stakeholders Inclusion Criteria for Aim 3
External site stakeholders Exclusion Criteria for Aim 3
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| Name | Affiliation | Role |
|---|---|---|
| Jamie M Faro, PhD | UMass Chan Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Massachusetts Chan Medical School | Worcester | Massachusetts | 01605 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D002318 | Cardiovascular Diseases |
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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Stepped-wedge sequential crossover design
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| Standard Referral | Behavioral | The standard referral period will serve as the "usual care" comparator. Patients will receive a paper referral and Fitbit monitor. |
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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 |