The Engaging Primary Care in Cancer Survivorship (EPICS) Study (EPICS)

The EPICS (Engaging Primary Care in Cancer Survivorship) Study: A Trial of Novel Models of Care for Cancer Survivors

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer; Colorectal Cancer
• Intervention / Treatment: Other: Embedded primary care in cancer survivorship model

Detailed Description

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. The trial will test the efficacy of an embedded primary care provider (PCP) model (experimental condition) in which PCPs are embedded within an oncology practice and will care for low-risk survivors who will be transitioned at 6-36 months post-treatment for comprehensive survivorship care. We hypothesize that a) patients in the PCP model will have superior receipt of recommended care compared to usual care; b) patients in the PCP model will perceive significantly better care coordination, self-efficacy, and confidence in their PCP compared to usual care; and c) use of unplanned and non-recommended care will be less in the PCP model compared to usual care.

• Study Type: Interventional
• Enrollment (Estimated): 2450
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92806
      • Kaiser Permanente Orange County Anaheim/Irvine Medical Center Oncology Clinics
    • Baldwin Park, California, United States, 91706
      • Kaiser Permanente Baldwin Park Medical Center Oncology Clinic
    • Downey, California, United States, 90242
      • Kaiser Permanente Downey/Bellflower Medical Center Oncology Clinics
    • Fontana, California, United States, 92335
      • Kaiser Permanente Fontana Medical Center Oncology Clinic
    • Harbor City, California, United States, 90710
      • Kaiser Permanente South Bay Medical Center Oncology Clinic
    • Kern, California, United States, 93306
      • Kaiser Permanente Kern County Medical Facilities Oncology Clinic
    • Lancaster, California, United States, 93534
      • Kaiser Permanente Antelope Valley Medical Center Oncology Clinic
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente Los Angeles Medical Center Oncology Clinic
    • Los Angeles, California, United States, 90034
      • Kaiser Permanente West Lost Angeles Medical Center Oncology Clinic
    • Panorama City, California, United States, 91402
      • Kaiser Permanente Panorama City Medical Center Oncology Clinic
    • Riverside, California, United States, 92505
      • Kaiser Permanente Riverside/Palm Springs Medical Center Oncology Clinics
    • San Diego, California, United States, 92123
      • Kaiser Permanente San Diego Medical Center Oncology Clinics
    • Woodland Hills, California, United States, 91367
      • Kaiser Permanente Woodland Hills Medical Center Oncology Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Condition; 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; 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.
No Intervention: Control Condition; Usual care for breast and colorectal cancer survivors (oncology-led model).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-recommended surveillance care/non-planned emergency and urgent care services	Receipt of non-recommended surveillance care based on current clinical guidelines, and use of non-planned hospitalization, emergency department, 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)	Validated measures of cancer survivorship financial burden, access to medical care, employment and employment patterns, healthcare utilization and expenditures, and use of prescription drugs by cancer survivors (Item #44; response options: 4-item Likert scale)	12 months
Patient-Centered Medical Home (PCMH) and Cancer Consumer Assessment of Healthcare Providers and Systems (CAHPS)	The Patient-Centered Medical Home (PCMH) Item Set is a set of supplemental questions that can be added to the adult and child versions of the CAHPS Clinician & Group Survey (CG-CAHPS) to gather more information on patient experience with the domains of primary care that define a medical home. However, use of this item set is not limited to practices that explicitly function as medical homes. Any primary care practice that is interested in a more comprehensive assessment of their patients' experiences may add the PCMH items to the survey (6 questions; response options: 3-item, 4-item or 6-item Likert scale).	12 months
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale v1.2 (answer responses using a Likert Scale)	As part of the Patient-Reported Outcomes Measurement Information System (PROMIS) created in 2004, The PROMIS Global-10 is a publically available global health assessment tool that allows measurements of symptoms, functioning, and healthcare-related quality of life (HRQoL) for a wide variety of chronic diseases and conditions (10 questions; response options: 5-item 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)	The PROMIS adult Self-Efficacy for Managing Chronic Conditions Symptoms Scale assesses self-reported current level of confidence in managing symptoms from chronic health conditions (8 questions; response options: 5-item Likert scale).	12 months
The European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (version 3)	Questionnaire developed to assess the quality of life of cancer patients (30 questions; response options: 4-item or 7-item Likert scale)	12 months
Receipt of Treatment Summary from Health Information and National Trends Survey (HINTS 4, Cycle 2)	The Health Information National Trends Survey (HINTS) regularly collects nationally representative data about the American public's knowledge of, attitudes toward, and use of cancer- and health-related information (1 question; response option: yes/no).	12 months
Primary Care Delivery of Survivorship Care Scale	Self-reported measure of perceived survivorship care (6 questions; response options: 5-item Likert scale)	12 months
Patient-Reported Bother from Side Effects of Cancer Therapy (Validated Single-Item Measure)	The single item "I am bothered by side effects of treatment" (GP5), rated on a 5-point Likert scale, is part of the Functional Assessment of Cancer Therapy-General (FACT-G) version (1 question; response option: 5-item Likert scale)	12 months
The Satisfaction with Decision Scale	(6 questions; response options: 4-item Likert Scale)	12 months
Confidence in Managing Survivorship Care	Questionnaire assessing self-reported receipt of survivorship care planning, expectations of their providers, and confidence in managing their survivorship care (5 questions; response options: 4-item Likert scales).	12 months
Cancer recurrence	Single item, question: Did a doctor or other health professional ever tell you that your cancer had come back? (response option: yes/no). 1a. If yes, what was the most recent year a doctor or other health professional told you that your cancer had come back? _______________	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported patient demographics	gender, race/ethnicity; insurance type; highest level education; school/employment status; total household income	12 months

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Erin E. Hahn, PhD, MPH, Kaiser Permanente Southern California, Department of Research & Evaluation

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2021
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: January 25, 2021
• First Submitted That Met QC Criteria: February 4, 2021
• First Posted (Actual): February 9, 2021

Study Record Updates

• Last Update Posted (Estimated): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Cancer survivorship; Models of care
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Colorectal Neoplasms; Breast Neoplasms
• Other Study ID Numbers: R01CA249419 (U.S. NIH Grant/Contract); 1R01CA249419-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No