Cancer, Cardiovascular Diseases, Physical Inactivity
Conditions
Brief summary
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.
Interventions
BEHAVIORALEnhanced Referral
The enhanced referral uses an electronic referral and patient decision aid to provide choices to 3 different physical activity programs.
BEHAVIORALStandard Referral
The standard referral period will serve as the "usual care" comparator. Patients will receive a paper referral and Fitbit monitor.
Sponsors
University of Massachusetts, Worcester
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Stepped-wedge sequential crossover design
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
Yes
Inclusion criteria
AIM 1 Inclusion Criteria for Aim 1a 1. Prior cancer diagnosis 2. 18 years of age and older 3. Speaks English
Exclusion criteria
for Aim 1a 1. No prior cancer diagnosis 2. Under 18 years of age 3. Prisoners 4. Does not speak English AIM1B Survivor Inclusion Criteria for Aim 1b 1. Prior cancer diagnosis 2. 18 years of age and older 3. Speaks English Survivor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients referred as obtained by the electronic referral system and electronic health record | Baseline | The number of patients referred/The number of eligible patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of eligible clinicians enrolling in the the study | Baseline | Number of enrolled clinicians/Number of eligible clinicians |
| Clinic/Clinician fidelity of delivering patient decision aids | Baseline | Clinic delivery of patient decision aids as reported by patients |
| Patient Engagement | Examined at baseline, 3-, and 6-months | Program enrollment (number referred/number enrolled); |
| Patient Retention | 3- and 6-months | Percent of enrolled patients completing follow-up surveys at 3- and 6-months |
| Patient narrative decision aid acceptability and effectiveness (Enhanced Referral only) | Baseline following referrals | 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 |
| Patient Autonomous Regulation | Baseline, 3- and 6-months | Behavioral Regulation for Exercise Questionnaire-2 (Minimum=0, Maximum=76; Higher scores indicates greater regulation/motivation) |
| Patient Objective Physical Activity | Baseline, 3- and 6-months | Change from baseline to 3- and 6-months in steps, light, moderate and vigorous physical activity measured via Fitbits. |
| Patient Self-Report Physical Activity | Baseline, 3- and 6-months | 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. |
| Patient Health-related Quality of Life | Baseline, 3- and 6-months | 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) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJamie M Faro, PhD
UMass Chan Medical School
Outcome results
None listed