About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
PC2: Primary Care Connect
Other interventionPrimary Care Connect is a health system intervention that includes patient education, electronic medical record optimization, protocolized communication from cancer care team to primary care.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
HEDIS quality measure of management hypertension
blood pressure \<140/90mm Hg
HEDIS quality measure of management diabetes
A1c\<8.0%
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.
Other outcomes
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: