CancerACCESS-PCNCT06834204
Advancing Care Coordination Between Cancer and Primary Care Teams for Complex Cancer Survivors
A study testing PC2: Primary Care Connect in people with Cancer and Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Breast Cancer Early Stage Breast Cancer (Stage 1-3), Bladder Cancer
- What is being tested?
- PC2: Primary Care Connect
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2026to 30 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Rutgers Cancer Institute
New Brunswick, New Jersey, 08901
About this study
Official title: 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:
Read more
- 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
Read the 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.
- Conditions
- Cancer, Breast Cancer Early Stage Breast Cancer (Stage 1-3), Bladder Cancer, Prostate Cancer (Adenocarcinoma), Endometrial Cancer, Hypertension
- Being tested
- PC2: Primary Care Connect
- Keywords
- primary care, cancer, cardiovascular, shared care, care coordination, implementation, cancer multi-team system, complex cancer survivor
- Medical subject headings
- Neoplasms, Urinary Bladder Neoplasms, Prostatic Neoplasms, Adenocarcinoma, Endometrial Neoplasms, Hypertension, Hyperlipidemias, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PC2: Primary Care ConnectOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Patients in this arm will not receive the intervention. |
| Primary Care Connect (PC2) | Experimental | 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. Receives: Other: PC2: Primary Care Connect |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the time of enrollment to 18-months post enrollment.
Secondary outcomes (3)
HEDIS quality measure of management hypertension
blood pressure <140/90mm Hg
Measured: Baseline, 6-months, 12-months, and 18-months
HEDIS quality measure of management diabetes
A1c<8.0%
Measured: 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.
Measured: Baseline, 6-months, 12-months, and 18-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start24 Apr 2026
- Primary completion1 Jul 2028 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Denalee O'Malley, Rutgers, The State University of New Jersey
- Investigators
- Denalee M O'Malley, PhD, MSW, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06834204
- Sponsor's protocol ID
- Pro2024000262
- Acronym
- ACCESS-PC
- Status last verified
- Jul 2026
- First submitted
- 4 Feb 2025
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Fadem SJ, Crabtree BF, Hemler JR, Dhaliwal K, Ohman-Strickland P, Ferrante JM, Hudson SV, O'Malley DM. Advancing care coordination to enhance shared care for complex cancer survivors in primary care (ACCESS-PC): protocol for a hybrid type 3 effectiveness-implementation trial. BMC Prim Care. 2026 Jul 22;27(1):376. doi: 10.1186/s12875-026-03484-2.
PubMed 42897469
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACCESS-PC: Advancing Care Coordination to Enhance Shared Care for Complex Cancer Survivors in Primary Care.
- ClinicalTrials.gov ID
- NCT06834204
- Acronym / sponsor ID
- ACCESS-PC / Pro2024000262
- Conditions
- Cancer, Breast Cancer Early Stage Breast Cancer (Stage 1-3), Bladder Cancer, Prostate Cancer (Adenocarcinoma), Endometrial Cancer, Hypertension
- Keywords
- primary care, cancer, cardiovascular, shared care, care coordination, implementation, cancer multi-team system, complex cancer survivor
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 24 Apr 2026 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Patients in this arm will not receive the intervention. |
| Primary Care Connect (PC2) | Experimental | Other: PC2: Primary Care ConnectPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PC2: Primary Care ConnectPrimary Care Connect is a health system intervention that includes patient education, electronic medical record optimization, protocolized communication from cancer care team to primary care. | Other | Primary Care Connect (PC2) |
Primary outcome
Connected Care-Continuity with Primary Care Provider
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.
3 secondary outcomes
HEDIS quality measure of management hypertension
Time frame: Baseline, 6-months, 12-months, and 18-months
HEDIS quality measure of management diabetes
Time frame: Baseline, 6-months, 12-months, and 18-months
HEDIS quality measure of management of statin use
Time frame: Baseline, 6-months, 12-months, and 18-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Derived from this study: PubMed 42897469Fadem SJ, Crabtree BF, Hemler JR, Dhaliwal K, Ohman-Strickland P, Ferrante JM, Hudson SV, O'Malley DM. Advancing care coordination to enhance shared care for complex cancer survivors in primary care (ACCESS-PC): protocol for a hybrid type 3 effectiveness-implementation trial. BMC Prim Care. 2026 Jul 22;27(1):376. doi: 10.1186/s12875-026-03484-2.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Denalee M O'Malley, PhD, MSW principal investigator
Rutgers, The State University of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PC2: Primary Care Connect in people with Cancer and Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Connected Care-Continuity with Primary Care Provider (time frame: From the time of enrollment to 18-months post enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06834204, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.