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.
1 other identifier
interventional
266
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cancer
Started Apr 2026
Typical duration for not_applicable cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2025
CompletedFirst Posted
Study publicly available on registry
February 19, 2025
CompletedStudy Start
First participant enrolled
April 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2029
March 23, 2026
March 1, 2026
2.2 years
February 4, 2025
March 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
HEDIS quality measure of management hypertension
Baseline, 6-months, 12-months, and 18-months
HEDIS quality measure of management diabetes
Baseline, 6-months, 12-months, and 18-months
HEDIS quality measure of management of statin use
Baseline, 6-months, 12-months, and 18-months
Other Outcomes (1)
Self-efficacy for Managing Chronic Conditions and Patient Centered Communication
Baseline, 6-months, 12-months, and 18-months
Study Arms (2)
Usual Care
NO INTERVENTIONPatients in this arm will not receive the intervention.
Primary Care Connect (PC2)
EXPERIMENTALPatients 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rutgers RWJ Medical School
Somerset, New Jersey, 08901, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dena O'Malley, PhD, MSW
Rutgers, The State University of New Jersey
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor Rutgers RWJ Medical School Dept Family Medicine and Community Health
Study Record Dates
First Submitted
February 4, 2025
First Posted
February 19, 2025
Study Start
April 15, 2026
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
April 30, 2029
Last Updated
March 23, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ANALYTIC CODE
- 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.
- 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.
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.