Rutgers Cancer Institute
New Brunswick, New Jersey, 08901, United States
NCT Number: NCT06834204
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
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
New Brunswick, New Jersey, 08901, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: From the time of enrollment to 18-months post enrollment.
Three primary care visits focused on chronic disease management from time of enrollment to 18-months post-enrollment.
Time frame: Baseline, 6-months, 12-months, and 18-months
blood pressure <140/90mm Hg
Time frame: Baseline, 6-months, 12-months, and 18-months
A1c<8.0%
Time frame: Baseline, 6-months, 12-months, and 18-months
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.
Time frame: Baseline, 6-months, 12-months, and 18-months
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.
Rutgers, The State University of New Jersey
Other
ACCESS-PC: Advancing Care Coordination to Enhance Shared Care for Complex Cancer Survivors in Primary Care.
Acronym: ACCESS-PC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04258813
Adenocarcinoma, Adnexal Diseases
Durham, North Carolina, United States
View Trial DetailsNCT05874726
Apnea, Body Weight
Boston, Massachusetts, United States
View Trial DetailsNCT03452774
Adenocarcinoma, Adnexal Diseases
Birmingham, Alabama, United States
View Trial DetailsNCT03987633
Arrhythmias, Cardiac, Arterial Occlusive Diseases
Wolverhampton, West Midlands, United Kingdom
View Trial Details