Advancing Care Coordination Between Cancer and Primary Care Teams for Complex Cancer Survivors

NCT ID: NCT06834204

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 266 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2029-04-30

Brief Summary

The purpose of this randomized clinical trial is to learn if 'complex' cancer patients who receive care guided by a health system intervention, Primary Care Connect (PC2) have their risks of cardiovascular disease (CVD) managed better than those who receive usual care. This study focuses on "complex" cancer survivors who have higher CVD risk when diagnosed with cancer because they also have had a diagnosis of 1 or more chronic conditions (e.g., hypertension, diabetes, and/or hyperlipidemia) requiring medication management. This study also aims to learn about the ease of implementing the health system intervention from the perspectives of cancer teams, primary care teams, and complex cancer patients.

The main questions the study aims to answer are:

• Do patients enrolled in the PC2 arm remain connected to their primary care teams during active cancer treatment for chronic disease management compared to patients in usual care?
• Do patients enrolled in the PC2 arm have better management of their chronic conditions during active cancer treatment compared to patients in usual care?
• How do the care team and patients experience this change in care delivery related to their work and care experiences?

This study will compare complex cancer survivors who receive care according to the PC2 intervention to usual care to see if PC2 works to improve cardiovascular risk management.

Participants will:

• receive educational materials about the study upon enrollment
• complete on-line or written surveys at 4 times
• Visit the clinic for check ups and test related to the study 4 times

Detailed Description

Cancer survivors with cardiovascular disease risk factors (complex cancer survivors) are a growing population and their morbidity and mortality risks are significant. A shared care model (when two or more clinicians of different specialties care for the same patient) is the optimal care delivery model for complex cancer survivors and has been shown to produce optimal comorbidity management when primary care is involved.

Results from our ongoing and recent research studies indicate that survivors managing chronic conditions should not be disconnected from their primary care team. Therefore, feasibility issues must be addressed using stakeholder-informed strategies to enhance the translational potential of shared care that aligns multiple stakeholders (i.e., cancer care team, patients, primary care teams) understandings of this paradigm of care and build team-based care capacities.

This study employs a design-for-dissemination, theory guided perspective, blending implementation science and care delivery conceptual frameworks--Exploration, Planning, Implementation, and Sustainment (EPIS) and Cancer Multi-team System (cMTS)--to understand and address the multi-level factors of implementing shared care in a health system. These perspectives will shape tailoring and implementation of Primary Care Connect (PC2), a health system intervention designed to align complex cancer survivors, healthcare team members, and health system implementation actors' understandings, capacities, and practices to promote the adoption of shared care delivery models for complex cancer survivors.

Using a hybrid type III effectiveness-implementation design this study aims to: (1) engage diverse primary care and health system stakeholders to tailor PC2 to maximize implementation strategies fit to the health system and primary care practice contexts; (2) conduct a randomized controlled trial (n=266 patients) to test the effectiveness of PC2 on primary care connection, chronic disease management, and patient-reported outcomes; and, (3) evaluate PC2 implementation using a mixed methods approach to inform sustainable usage of the intervention. Study results are poised to have a profound impact on the adoption of shared care delivery models throughout the U.S. to optimally mitigate complex cancer survivors CVD risks.

Conditions

Cancer; Breast Cancer Early Stage Breast Cancer (Stage 1-3); Bladder Cancer; Prostate Cancer (Adenocarcinoma); Endometrial Cancer; Hypertension; Hyperlipidemia (E.G., Hypercholesterolemia); Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Usual Care

Patients in this arm will not receive the intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Primary Care Connect (PC2)

Patients enrolled in this arm will be provided print and video educational materials about the importance of shared care to manage existing and prevent exacerbations in chronic disease management. Additionally, their cancer care team will provide a brief protocolized communication to their primary care team that explain how their initial treatment may impact chronic disease management, clarifying the primary care role during acute treatment, and providing contact information for cancer team. Primary care providers of patients enrolled in this arm will receive an outreach packet that includes information provided in print and short video to explain the rationale of the intervention and the materials provided by the cancer care team.

Group Type: EXPERIMENTAL

PC2: Primary Care Connect

Intervention Type: OTHER

Primary Care Connect is a health system intervention that includes patient education, electronic medical record optimization, protocolized communication from cancer care team to primary care.

Interventions

PC2: Primary Care Connect

Primary Care Connect is a health system intervention that includes patient education, electronic medical record optimization, protocolized communication from cancer care team to primary care.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• diagnosed with any of the following cancers [Stage I-III]: breast, prostate, urinary bladder, and endometrial in the past 6 months;
• being treated for cancer with curative intent;
• had initial patient visit at the cancer center in the last 3 months;
• are being treated for cancer with curative intent at the Rutgers Cancer Institute of New Jersey
• have ≥1 CVD risk factor (hypertension, hyperlipidemia or type II diabetes) prior to cancer diagnosis that requires medication management;
• currently receiving care from a primary care provider or willing to initiate seeing a new primary care provider upon enrollment;
• Speak English or Spanish

Exclusion Criteria

• had myocardial infarction or stroke within the previous 1 year; (2) have heart failure with an ejection fraction <30%; (3) have stage IV-V chronic kidney disease (eGFR <30); or do not speak English or Spanish. Patients whose cancer progresses to metastatic disease during the course of the 18-month trial will be allowed to continue to participate unless they voluntarily withdraw

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Denalee O'Malley

Assistant Professor Rutgers RWJ Medical School Dept Family Medicine and Community Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dena O'Malley, PhD, MSW

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Locations

Rutgers RWJ Medical School

Somerset, New Jersey, United States

Countries

United States

Central Contacts

Denalee M. O'Malley, PhD, MSW

Role: CONTACT

omalledm@rutgers.edu

848-319-0004

Sarah Abbas

Role: CONTACT

sa1508@rwjms.rutgers.edu

7322354472

Facility Contacts

Sarah Abbas

Role: primary

sa1508@rwjms.rutgers.edu

732-235-4472

Other Identifiers

Pro2024000262

Identifier Type: -

Identifier Source: org_study_id