Clinical trial · Interventional
Pro-Change Population Health Solution
Integrative Platform for Primary Care Delivery of Evidence-Based Cancer Risk Behavior Interventions
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Risk Behavior | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PCPHC | Behavioral | — | UNRESOLVED |
| Usual care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PCPHC intervention
- description
- PCPHC intervention during 6-month intervention period plus study assessments at baseline, 6, and 12 months
- interventionNames
- Behavioral: PCPHC
- Other: Usual care
- type
- ACTIVE_COMPARATOR
- label
- Usual care
- description
- Usual primary care plus study assessments at baseline, 6, and 12 months
- interventionNames
- Other: Usual care
Primary outcomes (1)
- measure
- Change in number of cancer risk behaviors
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: Has at least one of the following behavioral risk factors for cancer: 1. Cigarette smoker 2. Exceeds recommended limits for alcohol intake 3. Does not meet national guidelines for physical activity 4. Overweight or obese Exclusion Criteria: 1. Currently pregnant 2. Currently undergoing cancer treatment 3. Serious medical condition that could prevent participation in the study for a full year 4. History of mania, schizophrenia, or other psychoses 5. Admitted to an inpatient mental health facility within the previous 2 years 6. Currently enrolled in the In It to Quit Study at the Community Health Center, Inc. 7. Unable to read English or Spanish 8. 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.
References
Publications (10)
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- BACKGROUNDGraham JW, Flay BR, Johnson CA, Hansen WB, Collins LM. Group comparability: A multiattribute utility measurement approach to the use of random assignment with small numbers of aggregated units. Evaluation Review 1984;8(2):247-60.
- BACKGROUNDHargraves JL, Hays RD, Cleary PD. Psychometric properties of the Consumer Assessment of Health Plans Study (CAHPS) 2.0 adult core survey. Health Serv Res. 2003 Dec;38(6 Pt 1):1509-27. doi: 10.1111/j.1475-6773.2003.00190.x. PMID 14727785
- BACKGROUNDKroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord. 2009 Apr;114(1-3):163-73. doi: 10.1016/j.jad.2008.06.026. Epub 2008 Aug 27. PMID 18752852
- BACKGROUNDProchaska JO, Redding C, Evers K. The Transtheoretical model and stages of change. In: Glanz K, Rimer BK, Viswanath K, editors. Health Behavior and Health Education: Theory, Research and Practice. 4 ed. San Francisco, CA: Jossey-Bass; 2008. p. 97-122.