Primary Care Connect for Cancer Survivors

(ACCESS-PC Trial)

Overseen By Sarah Abbas

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Must be taking: Hypertension, Hyperlipidemia, Diabetes

Disqualifiers: Recent myocardial infarction, Stroke, Heart failure, Kidney disease

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

266 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since it involves managing chronic conditions like hypertension, diabetes, and hyperlipidemia, it's likely you will continue your current medication regimen.

Is Primary Care Connect safe for cancer survivors?

The research does not provide specific safety data for Primary Care Connect, but it discusses the safe transition of cancer survivors to primary care, suggesting that those with low risk of adverse events are considered appropriate for this transition. ^{1 2 3 4 5}

How is the Primary Care Connect treatment for cancer survivors different from other treatments?

Primary Care Connect is unique because it focuses on integrating primary care with cancer specialist care to better address the ongoing needs of cancer survivors, ensuring a smoother transition and more coordinated care after cancer treatment. ^{1 2 6 7 8}

What data supports the effectiveness of the treatment Primary Care Connect for cancer survivors?

The research highlights that effective communication and coordination between primary care and cancer specialists can improve treatment outcomes for cancer survivors. Structured follow-up by primary care teams and adherence to survivorship care plans have been shown to enhance patient satisfaction and healthcare use. ^{2 8 9 10 11}

Who Is on the Research Team?

Dena O'Malley, PhD, MSW

Principal Investigator

Rutgers, The State University of New Jersey

Are You a Good Fit for This Trial?

This trial is for 'complex' cancer survivors who also have chronic conditions like high blood pressure, diabetes, or high cholesterol. Participants should be on medication for these conditions and are now facing cardiovascular disease risks.

Inclusion Criteria

I visited the cancer center for the first time in the last 3 months.

I am currently seeing a doctor or willing to see one if I join the study.

I can speak English or Spanish.

Exclusion Criteria

My heart's pumping ability is very weak.

I can stay in the trial if my cancer spreads, unless I choose to leave.

I have not had a heart attack or stroke in the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment and Education

Participants receive educational materials about the study and the importance of shared care for chronic disease management

1 week

1 visit (in-person or virtual)

Active Treatment and Monitoring

Participants receive care guided by the Primary Care Connect (PC2) intervention or usual care, with regular check-ups and tests related to the study

18 months

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on chronic disease management and patient-reported outcomes

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Primary Care Connect

Trial Overview The study tests a health system intervention called Primary Care Connect (PC2) to see if it helps manage cardiovascular risk better than usual care. It involves staying connected with primary care during cancer treatment and managing chronic diseases.

How Is the Trial Designed?

Group I: Primary Care Connect (PC2) Experimental Treatment 1 Intervention

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.

Group II: Usual Care Active Control 1 Intervention

Patients in this arm will not receive the intervention.

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Published Research Related to This Trial

Rural primary care providers (PCPs) face significant barriers in delivering cancer survivorship care, including organizational challenges, unclear roles with specialists, and a lack of knowledge about survivorship guidelines, as identified in focus groups with seven PCP teams.

An interdisciplinary training program called iSurvive was developed and tested, leading to changes in practice among PCPs to better identify and provide evidence-based care for cancer survivors, highlighting the need for improved collaboration between oncology and primary care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Informing the delivery of cancer survivorship care in rural primary care practice. Klemp, JR., Knight, CJ., Lowry, B., et al.[2022]

A study involving 13 primary care clinicians highlighted the need for improved survivorship care plans (SCPs) that are more user-friendly and relevant for primary care settings, emphasizing follow-up care over treatment summaries.

Clinicians found the redesigned SCPs valuable but noted that significant effort is required to integrate the information into their health records, indicating a need for better formats that facilitate easier data entry.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Re-engineering Survivorship Care Plans to Support Primary Care Needs and Workflow: Results From an Engineering, Primary Care and Oncology Collaborative for Survivorship Health (EPOCH). Tevaarwerk, AJ., Zhang, X., Haine, J., et al.[2023]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Effects of structured involvement of the primary care team versus standard care after a cancer diagnosis on patient satisfaction and healthcare use: the GRIP randomised controlled trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Improving Care Coordination to Optimize Health Outcomes in Cancer Survivors. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Informing the delivery of cancer survivorship care in rural primary care practice. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Optimizing cancer survivorship in primary care: patient experiences from the Johns Hopkins Primary Care for Cancer Survivors clinic. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

The role of primary care in the cancer care continuum: a qualitative study of cancer survivors' experiences. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Breast, colorectal and prostate cancer screening for cancer survivors and non-cancer patients in community practices. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Optimizing Cancer Survivorship Care: Examination of Factors Associated with Transition to Primary Care. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Re-engineering Survivorship Care Plans to Support Primary Care Needs and Workflow: Results From an Engineering, Primary Care and Oncology Collaborative for Survivorship Health (EPOCH). [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Practice, Preferences, and Practical Tips From Primary Care Physicians to Improve the Care of Cancer Survivors. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

The Johns Hopkins Primary Care for Cancer Survivor Clinic: lessons learned in our first 4 years. [2020]

11. Australia pubmed.ncbi.nlm.nih.gov

A clinical placement program for primary care professionals at a comprehensive cancer centre. [2019]