The Engaging Primary Care in Cancer Survivorship (EPICS) Study

NCT04745754 | Active Not Recruiting DMC

• 2 other identifiers: R01CA2494191R01CA249419-01
• Study Type: interventional
• Target: 2,450
• Locations: 1 country
• Sites: 13

Brief Summary

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.

Conditions

Breast Cancer; Colorectal Cancer

Keywords

Cancer survivorship; Models of care

Outcome Measures

Primary Outcomes (2)

• Cancer surveillance care services

  Receipt of guideline-recommended cancer surveillance care services.

  36 months

• Preventive care services

  Receipt of guideline-recommended preventive care services.

  36 months

Secondary Outcomes (12)

• Non-recommended surveillance care/non-planned emergency and urgent care services

  36 months

• Medical Expenditure Panel Survey (MEPS) 2016, Experiences with Cancer Supplement, Section 7, Medical Care for Cancer Module (Item #44)

  12 months

• Patient-Centered Medical Home (PCMH) and Cancer Consumer Assessment of Healthcare Providers and Systems (CAHPS)

  12 months

• Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale v1.2 (answer responses using a Likert Scale)

  12 months

• Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Chronic Conditions Symptoms Scale (Self-efficacy for managing symptoms short form 8a (8 questions; 5-item Likert scale)

  12 months

Other Outcomes (1)

• Self-reported patient demographics

  12 months

Study Arms (2)

Intervention Condition

EXPERIMENTAL

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.

Other: Embedded primary care in cancer survivorship model

Control Condition

NO INTERVENTION

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

Interventions

Embedded primary care in cancer survivorship model OTHER

Primacy care physicians will receive comprehensive training in cancer survivorship care for low-risk, early stage breast and colorectal patients. Training will include continuing medical education (CME) modules, webinars, and in-person discussion and clinical shadowing.

Intervention Condition

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients: Adult (21+) Kaiser Permanente Southern California members diagnosed and treated for pathologically confirmed first primary early-stage breast (stage 0, I, II) or colorectal (stage I, II) cancer within Kaiser Permanente Southern California. Completed active cancer treatment within the past 6-36 months; active treatment includes cancer-directed surgery, chemotherapy (includes Herceptin (Trastuzumab)), radiation therapy, and ovarian suppression therapy (e.g., Goserelin (Zoladex)). Completed at least one office visit within Kaiser Permanente Southern California medical oncology. At low-risk for cancer recurrence and treatment-related toxicities based on state of disease and treatment modalities. For our Aim 2 survey: Primary language of English or Spanish (although we will assess our Aim 1 participants for recorded preferred spoken language and adjust translations as needed). Ability to complete surveys of patient-reported outcomes.
• 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.

You may not qualify if:

• Patients less than 21 years of age
• Patients at high risk for recurrence and treatment-related toxicities based on stage of disease and treatment modalities

Sponsors & Collaborators

• Kaiser Permanente: lead
• National Cancer Institute (NCI): collaborator

Study Sites (13)

Kaiser Permanente Orange County Anaheim/Irvine Medical Center Oncology Clinics

Anaheim, California, 92806, United States

Location

Kaiser Permanente Baldwin Park Medical Center Oncology Clinic

Baldwin Park, California, 91706, United States

Location

Kaiser Permanente Downey/Bellflower Medical Center Oncology Clinics

Downey, California, 90242, United States

Location

Kaiser Permanente Fontana Medical Center Oncology Clinic

Fontana, California, 92335, United States

Location

Kaiser Permanente South Bay Medical Center Oncology Clinic

Harbor City, California, 90710, United States

Location

Kaiser Permanente Kern County Medical Facilities Oncology Clinic

Kern, California, 93306, United States

Location

Kaiser Permanente Antelope Valley Medical Center Oncology Clinic

Lancaster, California, 93534, United States

Location

Kaiser Permanente Los Angeles Medical Center Oncology Clinic

Los Angeles, California, 90027, United States

Location

Kaiser Permanente West Lost Angeles Medical Center Oncology Clinic

Los Angeles, California, 90034, United States

Location

Kaiser Permanente Panorama City Medical Center Oncology Clinic

Panorama City, California, 91402, United States

Location

Kaiser Permanente Riverside/Palm Springs Medical Center Oncology Clinics

Riverside, California, 92505, United States

Location

Kaiser Permanente San Diego Medical Center Oncology Clinics

San Diego, California, 92123, United States

Location

Kaiser Permanente Woodland Hills Medical Center Oncology Clinic

Woodland Hills, California, 91367, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Erin E. Hahn, PhD, MPH

  Kaiser Permanente Southern California, Department of Research & Evaluation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist I

Model Details: Embedded primary care providers (PCPs) will provide comprehensive care for survivors, including cancer surveillance services, preventive care, and management of long-term therapy and associated side effects (e.g., endocrine therapy in breast survivors). A comprehensive multilevel approach will prepare survivors and PCPs (physicians and/or advance practice providers). Eligible patients in the embedded PCP model will be provided with tailored education regarding the planned transition and, after cessation of active treatment, printed information on the planned course of care, expectations for embedded PCP care, transition timing, and reassurance that the oncology team will be available via telephone and email, and that PCPs will refer back to the oncologist for any concerning signs or symptoms. Tailored alerts will also be added to the electronic medical record (EMR) for recommended cancer surveillance and preventive care services that will fire for visits with embedded PCPs.

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: February 9, 2021
• Study Start: September 21, 2021
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)