Advancing Care Coordination Between Cancer and Primary Care Teams for Complex Cancer Survivors (NCT06834204) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Advancing Care Coordination Between Cancer and Primary Care Teams for Complex Cancer Survivors
United States266 participantsStarted 2026-04-15
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Connected Care-Continuity with Primary Care Provider
Timeframe: From the time of enrollment to 18-months post enrollment.
Trial details
NCT IDNCT06834204
SponsorRutgers, The State University of New Jersey