ActivityChoice: Implementing Clinic-Based Physical Activity Program Choices for Cancer Survivors
- Conditions
- Cardiovascular DiseasesPhysical InactivityCancer
- Interventions
- Behavioral: Standard ReferralBehavioral: Enhanced Referral
- Registration Number
- NCT05870176
- Lead Sponsor
- University of Massachusetts, Worcester
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 114
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Standard Referral Standard Referral Provider education/training on referral process Patient education material on physical activity benefits Paper referral to LIVESTRONG at the YMCA Fitbit Activity Monitor Enhanced Referral Enhanced Referral 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Proportion of eligible clinicians enrolling in the the study Baseline Number of enrolled clinicians/Number of eligible clinicians
Patient Engagement Examined at baseline, 3-, and 6-months Program enrollment (number referred/number enrolled);
Clinic/Clinician fidelity of delivering patient decision aids Baseline Clinic delivery of patient decision aids as reported by patients
Patient Retention 3- and 6-months Percent of enrolled patients completing follow-up surveys at 3- and 6-months
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 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 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 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)
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.
Trial Locations
- Locations (1)
University of Massachusetts Chan Medical School
🇺🇸Worcester, Massachusetts, United States