Advancing Care Coordination Between Cancer and Primary Care Teams for Complex Cancer Survivors (ACCESS-PC)

ACCESS-PC: Advancing Care Coordination to Enhance Shared Care for Complex Cancer Survivors in Primary Care.

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

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension; Diabetes Mellitus; Cancer; Bladder Cancer; Endometrial Cancer; Prostate Cancer (Adenocarcinoma); Breast Cancer Early Stage Breast Cancer (Stage 1-3); Hyperlipidemia (E.G., Hypercholesterolemia)
• Intervention / Treatment: Other: PC2: Primary Care Connect

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.

• Study Type: Interventional
• Enrollment (Estimated): 266
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Denalee M. O'Malley, PhD, MSW; Phone Number: 848-319-0004; Email: omalledm@rutgers.edu
• Study Contact Backup: Name: Sarah Abbas; Phone Number: 7322354472; Email: sa1508@rwjms.rutgers.edu

Study Locations

• United States
  • New Jersey
    • Somerset, New Jersey, United States, 08901
      • Rutgers RWJ Medical School
      • Contact: Sarah Abbas; Phone Number: 732-235-4472; Email: sa1508@rwjms.rutgers.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;
• Speak English or Spanish

Exclusion Criteria:

• had myocardial infarction or stroke within the previous 1 year;
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; Patients in this arm will not receive the intervention.
Experimental: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Connected Care-Continuity with Primary Care Provider	Three primary care visits focused on chronic disease management from time of enrollment to 18-months post-enrollment.	From the time of enrollment to 18-months post enrollment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HEDIS quality measure of management hypertension	blood pressure <140/90mm Hg	Baseline, 6-months, 12-months, and 18-months
HEDIS quality measure of management diabetes	A1c<8.0%	Baseline, 6-months, 12-months, and 18-months
HEDIS quality measure of management of statin use	Statin use if patient is diabetic or has a 10-year ASCVD risk >10%. To evaluate statin use, the research team will measure fasting laboratory lipid profile at the time of each study assessment.	Baseline, 6-months, 12-months, and 18-months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-efficacy for Managing Chronic Conditions and Patient Centered Communication	Self-efficacy for managing chronic conditions: the PROMIS measures will be used to assess and individual's confidence in his/her ability to successfully perform specific tasks or behaviors related to one's health in a variety of situations assessing five domains: daily activities, symptoms, medications and treatments, emotions and social interactions. Patient centered communication with both the cancer and primary care teams will be assessed using the validated 7-item scale. We will adapt this scale slightly to use a 6-month recall period given intensity of care during the active cancer and our planned assessment intervals.	Baseline, 6-months, 12-months, and 18-months

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Investigators: Principal Investigator: Dena O'Malley, PhD, MSW, Rutgers, The State University of New Jersey

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): April 30, 2029

Study Registration Dates

• First Submitted: February 4, 2025
• First Submitted That Met QC Criteria: February 18, 2025
• First Posted (Actual): February 19, 2025

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: cancer; primary care; care coordination; cardiovascular; implementation; shared care; cancer multi-team system; complex cancer survivor
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Neoplasms by Histologic Type; Uterine Diseases; Genital Diseases, Female; Glucose Metabolism Disorders; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Urologic Neoplasms; Carcinoma; Uterine Neoplasms; Dyslipidemias; Lipid Metabolism Disorders; Urinary Bladder Diseases; Nutritional and Metabolic Diseases; Neoplasms; Prostatic Neoplasms; Hypertension; Diabetes Mellitus; Hypercholesterolemia; Adenocarcinoma; Urinary Bladder Neoplasms; Endometrial Neoplasms; Hyperlipidemias
• Other Study ID Numbers: Pro2024000262

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The cleaned, item-level spreadsheet data for all variables will be shared openly, along with example quantifications and transformations from initial raw data. The rationale for sharing only cleaned data is to foster ease of data reuse.

The final dataset will include self-reported demographic and behavioral data from participant surveys, interviews, and medical data from lab values and chart abstractions. We will share de-identified individual-participant level (IPD) data. Appropriate measures such as deleting or masking personal identifiers (for quantitative data), and generating quasi-identifiers (e.g., participant names in qualitative interviews) will be used for data de-identification and sharing, and informed consent forms will reflect those plans. All datasets that can be shared will be deposited in Dataverse, an NIH supported data sharing resource and generalist repository, managed by Harvard university.

• IPD Sharing Time Frame: Shared data generated from this project will be made available as soon as possible, and no later than the time of publication or the end of the funding period, whichever comes first. The duration of preservation and sharing of the data will be a minimum of 10 years after the end of the funding period.

IPD Sharing Access Criteria

Access/distribution/reuse of the resulting health system implementation actor scientific data (i.e., implementation planning group transcripts, interviews, nurse diaries) will be limited because even after de-identification, individuals, teams and organizations would be inferentially identifiable based on the context. Access to these data will be approved/monitored by the study PIs.

Survey data and clinical trial data will be de-identified and contextual identifiers will be removed prior to sharing. All sharing will comply with local, state and federal laws and regulations, including HIPAA Privacy and Security Rules. Data will be de-identified before presentations and publications, as well as any datasets shared with qualified researchers who have obtained appropriate IRB approvals.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No