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

Trial Summary

What is the purpose of this trial?

A quasi-experimental non-randomized pre/post with control group trial of two models of cancer survivorship care in early-stage colorectal and breast cancer survivors cared for in a community-based, integrated health care setting.

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 data supports the effectiveness of the treatment Embedded primary care in cancer survivorship model?

Research suggests that involving primary care teams in the follow-up care of cancer survivors can improve patient satisfaction and healthcare use. Additionally, cancer survivors have expressed positive perspectives on receiving survivorship care from primary care physicians, indicating the potential effectiveness of this model. ^{1 2 3 4 5}

Is the Primary Care Model for Cancer Survivorship safe for humans?

The available research does not provide specific safety data for the Primary Care Model for Cancer Survivorship, but it focuses on the integration of primary care providers in cancer survivorship care, which is generally considered safe as it involves standard medical practices. ^{1 2 3 5 6}

How is the embedded primary care model for cancer survivorship different from other treatments?

The embedded primary care model for cancer survivorship is unique because it integrates primary care providers directly into the cancer survivorship care team, ensuring coordinated and comprehensive care for survivors. This approach contrasts with traditional models where primary care providers are not actively involved in the ongoing care of cancer survivors. ^{1 2 3 5 7}

Research Team

Erin E. Hahn, PhD, MPH

Principal Investigator

Kaiser Permanente Southern California, Department of Research & Evaluation

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Developing innovative models of care for cancer survivors: use of implementation science to guide evaluation of appropriateness and feasibility. [2021]

2. 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]

3. England pubmed.ncbi.nlm.nih.gov

Integrating primary care providers in the care of cancer survivors: gaps in evidence and future opportunities. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Cancer survivors' perspectives on delivery of survivorship care by primary care physicians: an internet-based survey. [2018]

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

Learning the landscape: implementation challenges of primary care innovators around cancer survivorship care. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Knowledge and self-efficacy for caring for breast and colon cancer survivors among safety net primary care providers. [2021]

7. 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]