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PCPHC intervention during 6-month intervention period plus study assessments at baseline, 6, and 12 months

Usual primary care plus study assessments at baseline, 6, and 12 months

Mobile-delivered health risk intervention (HRI), computer-tailored interventions (CTIs), text messages; provider-delivered one-on-one session guided by clinical dashboard

PCPHC

Usual care

Deborah A Levesque, Ph.D

Deborah Van Marter, M.P.H.

Daren Anderson, MD

Bridget Teevan, MPH

Deborah A Levesque, Ph.D.

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.

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:

1. Report whether the participant has received recommended cancer screenings;
2. Summarize data on targeted behavioral risks for cancer;
3. Summarize data on level of depression;
4. 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
5. 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.

Intervention group providers will deliver the dashboard-guided session at the patient's next clinic visit. The dashboard will be updated as the participant completes CTI sessions post-visit. Study participants who return to the clinic for any reason during the intervention period will be flagged, and the provider will use the dashboard to review progress and deliver updated stage-matched guidance.

All study participants will receive an online survey to assess outcomes at 6 and 12 months follow-up. Participants who don't complete the online survey within two weeks will be contacted by a survey research company to complete the survey by phone.

Pro-Change Population Health Solution

Integrative Platform for Primary Care Delivery of Evidence-Based Cancer Risk Behavior Interventions

Will only be assessed among patients smoking at baseline (exploratory analysis; study is not powered to find significance)

Will only be assessed among patients exceeding recommended limits at baseline (exploratory analysis; study is not powered to find significance)

Will be assessed using Godin's Leisure-Time Exercise Questionnaire (Godin \& Shephard, 1985) only among patients not meeting national guidelines for physical activity at baseline (exploratory analysis; study is not powered to find significance)

Will only be assessed among patients not meeting national guidelines for physical activity at baseline (exploratory analysis; study is not powered to find significance)

Will be calculated using height and weight only among patients who are overweight (BMI of 25 kg/m2 or higher) at baseline (exploratory analysis; study is not powered to find significance)

Progress to the Action stage for 1) reducing daily calorie intake by 500 calories/day, 2) limiting saturated and trans fat intake, 3) managing emotional distress, and 4) meeting national guidelines for physical activity will only be assessed among patients who are overweight (BMI of 25 kg/m2 or higher) at baseline (exploratory analysis; study is not powered to find significance)

Will be assessed using the Patient Health Questionnaire (PHQ-8) (Kroenke, Strine, Spritzer, Williams, Berry, \& Mokdad, 2009) only among patients with at least mild depression (PHQ-8 score of 5 or higher) at baseline (exploratory analysis; study is not powered to find significance)

Will only be assessed among patients with at least mild depression (PHQ-8 score of 5 or higher) at baseline (exploratory analysis; study is not powered to find significance)

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).

Change in consumer engagement will be computed by taking the difference in scores on the Altarum Consumer Engagement Measure (Duke, Lynch, Smith, \& Winstanley, 2015) from baseline to 12 months follow-up. The measure assesses four dimensions of engagement in healthcare: 1) commitment, 2) informed choice, 3) navigation, and 4) ownership.

Adherence with cancer screenings be the percentage of age- and gender-based U.S. Preventive Services Task Force-recommended screenings received during follow-up.

Change in patient satisfaction will be computed by taking the difference in participant scores on a 1-item global rating of satisfaction with care scale from baseline to 12 months follow-up. The scale is taken from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey (Agency for Healthcare Policy and Research, 1999; Hargraves, Hays, \& Cleary, 2003).

Change in well-being will be computed by taking the difference in the Cantril Self-Anchoring Scale (Cantril, 1965) from baseline to 12 months follow-up. The measure asks participants to imagine a ladder with steps numbered from zero to ten, with the top representing the best possible life and the bottom representing the worst possible life, and to indicate where they feel their life falls currently and where it will be in five years.

Change in well-being will be computed by taking the difference in the Centers for Disease Control and Prevention Healthy Days (2000) Core Measures from baseline to 12 months follow-up. The measures assess overall self-rated health, recent physical symptoms, recent mental and emotional distress, and recent activity limitations.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Pro-Change Population Health Solution	NCT02755636	Risk Behavior	PCPHC Usual care	21 Years - 75 Years	Pro-Change Behavior Systems
Pro-Change Population Health Solution	NCT02755636	Risk Behavior	PCPHC Usual care	21 Years - 75 Years	Pro-Change Behavior Systems

Spots Global Cancer Trial Database for pcphc

Every month we try and update this database with for pcphc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pcphc

Every month we try and update this database with for pcphc cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pcphc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.