Integrative Platform for Primary Care Delivery of Evidence-Based Cancer Risk Behavior Interventions
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 780
- Locations
- 4
- Primary Endpoint
- Change in number of cancer risk behaviors
Study Overview
Brief Summary
Patients with co-occurring health risk behaviors suffer greater morbidity, disability, and premature death. The Pro-Change Population Health Solution (PCPHS) is a suite of mobile tools designed to assist patients and primary care providers (PCPs) in applying evidence-based principles of health behavior change to reduce four cancer risk behaviors-cigarette smoking, risky drinking, noncompliance with national guidelines for physical activity, and overweight and obesity-and depression among at-risk patients. The intervention is based on the Transtheoretical Model of Behavior Change (TTM, the "stage model") and includes computer-tailored interventions and text messages for patients and a clinical dashboard for providers. The efficacy of the intervention will be assessed in a cluster-randomized trial involving 780 patients recruited from 12 federally qualified health centers randomly assigned to intervention or usual care.
Detailed Description
A cluster-randomized design will be used to assess the efficacy of the PCPHS intervention for multiple behavior change for cancer prevention by comparing 6- and 12-month outcomes among 780 primary care patients recruited by 12 federally qualified health clinics randomly assigned to intervention or usual care. A Multiattribute Utility Measurement Approach will be used to ensure that clinics assigned to the two conditions are approximately equivalent on clinic size, patient demographics, and cancer risk behaviors (e.g., rates of smoking, overweight, and obesity). The most similar clinics will be paired, and one clinic within each pair will be assigned to intervention, and the other to usual care.
Patients with an upcoming appointment and who meet study inclusion criteria will be invited to participate in the study, which will begin with an online baseline survey. In addition, patients in the intervention group will complete an online health risk intervention (HRI) that assesses and intervenes on the four cancer risk behaviors targeted in the intervention-cigarette smoking, risky drinking, noncompliance with national guidelines for physical activity, and overweight and obesity-as well depression. It will also assess whether participants have received cancer screenings recommended by age and gender.
After the HRI session, intervention participants will have access to the TTM CTIs targeting their risk factors during the next six months. Patients assigned to the usual care condition will receive care as usual.
Providers at the six clinics assigned to intervention will receive training on the TTM and the clinical dashboard. They will have access to the dashboard via the patient electronic medical record (EMR) during the intervention period, and will be expected to use the dashboard to deliver the one-on-one component of the TTM intervention. The clinical dashboard will:
- Report whether the participant has received recommended cancer screenings;
- Summarize data on targeted behavioral risks for cancer;
- Summarize data on level of depression;
- For each cancer risk behavior, show stage of change for meeting recommended guidelines; if at least mild depression show stage of change for using healthy strategies to manage depression; and
- For each cancer risk behavior and depression management, provide stage-matched scripts providers can use to help participants progress to the next stage of change or to prevent relapse to an earlier stage.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 21 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Has at least one of the following behavioral risk factors for cancer:
- •Cigarette smoker
- •Exceeds recommended limits for alcohol intake
- •Does not meet national guidelines for physical activity
- •Overweight or obese
Exclusion Criteria
- •Currently pregnant
- •Currently undergoing cancer treatment
- •Serious medical condition that could prevent participation in the study for a full year
- •History of mania, schizophrenia, or other psychoses
- •Admitted to an inpatient mental health facility within the previous 2 years
- •Currently enrolled in the In It to Quit Study at the Community Health Center, Inc.
- •Unable to read English or Spanish
- •Unable to receive text messages
- •Note: Risky drinkers who screen positive for alcohol dependence will not be eligible for the intervention's risky drinking program, which focuses on limiting drinking to national guidelines. Treatment and control participants who screen positive for alcohol dependence and who are not engaging in any of the other targeted cancer risk behaviors will screen out of the study.
Outcomes
Primary Outcomes
Change in number of cancer risk behaviors
Time Frame: Baseline, 12 months
Change in number of cancer risk behaviors will be computed by taking the difference in the count of the four cancer risk behaviors (cigarette smoking, risky drinking, noncompliance with national guidelines for physical activity, and overweight and obesity) from baseline to 12 months follow-up. At each time point, the index will range from 0 to 4, with each risk behavior scored a "1" if present, and "0" if not present (Prochaska, Prochaska, \& Prochaska, 2014).
Secondary Outcomes
- Change in satisfaction with medical care(Baseline, 12 months)
- Change in well-being(Baseline, 12 months)
- Change in health-related quality of life(Baseline, 12 months)
- Change in consumer engagement(Baseline, 12 months)
- Adherence with cancer screenings(12 months)
Investigators
Deborah Levesque
Chief Science Officer
Pro-Change Behavior Systems