Primary Care Model for Cancer Survivorship

(EPICS Trial)

Recruiting at 12 trial locations

Overseen By Corrine E. Munoz-Plaza, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

Disqualifiers: High recurrence risk, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6-36 months

2450 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to care for individuals who have survived early-stage breast and colorectal cancer. It tests an approach called the "embedded primary care in cancer survivorship model," where specially trained primary care doctors collaborate closely with cancer specialists to support survivors. The goal is to determine if this method improves care compared to the usual cancer specialist-led follow-up. Individuals who completed treatment for early-stage breast or colorectal cancer within the last three years and are at low risk for recurrence might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative care models that could enhance survivorship experiences for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this primary care model for cancer survivorship is safe?

Research has shown that primary care doctors can safely lead follow-up care for cancer survivors. Studies have found that these doctors effectively manage the ongoing care of individuals who have completed cancer treatment. In these studies, primary care doctors trained in post-cancer treatment care attended to the patients.

The studies did not identify any major safety issues with this approach. Notably, about two-thirds of cancer survivors already consult primary care doctors, indicating the method's effectiveness. While the studies don't specify side effects, the absence of major safety problems is reassuring.

Overall, the evidence supports the safe care of cancer survivors by primary care doctors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to support cancer survivors by embedding specially trained primary care providers (PCPs) within oncology practices. Unlike the usual care, which is led by oncologists, this approach aims to transition low-risk, early-stage breast and colorectal cancer survivors to PCPs who are well-versed in survivorship care. This could offer a more personalized and holistic follow-up, potentially improving long-term health outcomes and overall quality of life for survivors.

What evidence suggests that the embedded primary care model is effective for cancer survivorship?

This trial will test the efficacy of an embedded primary care provider (PCP) model, where PCPs trained in survivorship work within an oncology practice. Studies have shown that primary care doctors trained in cancer survivorship can effectively collaborate with cancer specialists to benefit patients. Research indicates that this approach helps manage the long-term health of individuals who have survived early-stage breast and colorectal cancer. Patients have experienced better health outcomes when primary care is included in their follow-up care. This model ensures a smooth transition from active treatment to ongoing care, providing full support. It has performed better in some areas compared to care led solely by cancer specialists. ^{1 6 7 8 9}

Who Is on the Research Team?

Erin E. Hahn, PhD, MPH

Principal Investigator

Kaiser Permanente Southern California, Department of Research & Evaluation

Are You a Good Fit for This Trial?

The EPICS Study is for adult members of Kaiser Permanente Southern California who have been treated for early-stage breast or colorectal cancer within the last 6-36 months. They must be at low risk for recurrence, able to complete surveys in English or Spanish, and have had an oncology visit. High-risk patients and those under 21 are excluded.

Inclusion Criteria

Completed at least one office visit within Kaiser Permanente Southern California medical oncology.

Physicians: For centers assigned to the embedded primary care physician (PCP) model, PCPs selected to participate must be Board Certified in a relevant primary care specialty; hold a valid and current MD or advanced practitioner license; and be employed by the Southern California Permanente Medical Group.

My primary language is either English or Spanish.

Exclusion Criteria

I am at high risk of my cancer returning and experiencing side effects from treatment.

I am under 21 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive survivorship care through an embedded primary care provider model or usual oncology-led care

6-36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

Extension

Participants may continue to receive care and monitoring beyond the initial follow-up period

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Embedded primary care in cancer survivorship model

Trial Overview This study tests a new model where primary care is integrated into the follow-up process for cancer survivors. It compares outcomes before and after implementing this model among people who've survived early-stage breast or colorectal cancer.

How Is the Trial Designed?

Group I: Intervention Condition Experimental Treatment 1 Intervention

The trial will test the efficacy of an embedded primary care provider (PCP) model (experimental condition) in which PCPs are trained in survivorship and then embedded within an oncology practice to care for low-risk, early stage breast and colorectal cancer survivors who will be transitioned at 6-36 months post-treatment for comprehensive survivorship care.

Group II: Control Condition Active Control 1 Intervention

Usual care for breast and colorectal cancer survivors (oncology-led model).

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A formative evaluation involving 12 stakeholders revealed that oncologists and operational leaders found the embedded primary care provider survivorship care model acceptable and potentially beneficial for improving efficiency and quality of care, despite some concerns about the emotional impact on oncologists.

Patients expressed ambivalence towards the model, fearing that a new provider might not understand their history, highlighting the need for effective transition plans and training for primary care providers to ensure successful implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing innovative models of care for cancer survivors: use of implementation science to guide evaluation of appropriateness and feasibility. Hahn, EE., Munoz-Plaza, CE., Schottinger, JE., et al.[2021]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/OP.2025.21.10_suppl.1

Engaging Primary Care in Cancer Survivorship (EPICS) trial We tested a primary care physician (PCP)-led survivorship program compared to usual oncologist-led care for patients diagnosed with early-stage ...

2. clinicaltrial.be clinicaltrial.be/fr/details/176594?per_page=100&only_recruiting=0&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_eligible=0&only_active=0

The Engaging Primary Care in Cancer Survivorship ... Primacy care physicians will receive comprehensive training in cancer survivorship care for low-risk, early stage breast and colorectal patients ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2017.35.5_suppl.35

Building an embedded primary care survivorship model ... Successful implementation requires training and support of engaged PCPs and staff, and a formalized patient transition introduced early in the care trajectory.

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK609620/

Evaluating Different Types of Cancer Survivorship Care - NCBI Survivorship care clearly provides benefits to survivors, but different models perform better on different outcomes. The Oncology Embedded Model has higher ...

5. asco.org asco.org/news-initiatives/current-initiatives/cancer-care-initiatives/prevention-survivorship/survivorship-compendium/international-models-care

International Models of Care A 2019 review examined the effectiveness of nurse-led cancer survivorship care, compared with existing models. ... Nurse-led care appears to result in improved ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9189519/

Cancer Survivors, Oncology, and Primary Care Perspectives ... The purpose of this integrative review is to examine the literature on cancer survivorship care from the perspectives of the cancer survivor, ...

7. ascopubs.org ascopubs.org/doi/10.1200/OP.23.00818

Engaging Patients, Oncologists, and Primary Care ... We propose a coordinated care cancer survivorship model that engages patients and clinicians and that is supported by system-level solutions.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10234859/

Identifying the Needs of Primary Care Providers ... PCPs in the safety-net believe that providing comprehensive survivorship care requires coordination of care through the cancer continuum. Tools ...

9. academic.oup.com academic.oup.com/jnci/article/117/5/827/7876286

Enhancing capacity for primary care research in cancer ... Cancer survivorship care is complex. · Research has shown that approximately two-thirds of survivors receive care from primary care physicians.