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Active, Not Recruiting

NCT Number: NCT04745754

The Engaging Primary Care in Cancer Survivorship (EPICS) Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Orange County Anaheim/Irvine Medical Center Oncology Clinics, Anaheim, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Cancer surveillance care services

    Time frame: 36 months

    Receipt of guideline-recommended cancer surveillance care services.

  2. Preventive care services

    Time frame: 36 months

    Receipt of guideline-recommended preventive care services.

Secondary outcomes

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

    Time frame: 36 months

    Receipt of non-recommended surveillance care based on current clinical guidelines, and use of non-planned hospitalization, emergency department, and urgent care services.

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

    Time frame: 12 months

    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)

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

    Time frame: 12 months

    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).

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

    Time frame: 12 months

    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).

  5. 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)

    Time frame: 12 months

    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).

  6. The European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (version 3)

    Time frame: 12 months

    Questionnaire developed to assess the quality of life of cancer patients (30 questions; response options: 4-item or 7-item Likert scale)

  7. Receipt of Treatment Summary from Health Information and National Trends Survey (HINTS 4, Cycle 2)

    Time frame: 12 months

    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).

  8. Primary Care Delivery of Survivorship Care Scale

    Time frame: 12 months

    Self-reported measure of perceived survivorship care (6 questions; response options: 5-item Likert scale)

  9. Patient-Reported Bother from Side Effects of Cancer Therapy (Validated Single-Item Measure)

    Time frame: 12 months

    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)

  10. The Satisfaction with Decision Scale

    Time frame: 12 months

    (6 questions; response options: 4-item Likert Scale)

  11. Confidence in Managing Survivorship Care

    Time frame: 12 months

    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. Cancer recurrence

    Time frame: 12 months

    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? _______________

Other outcomes

  1. Self-reported patient demographics

    Time frame: 12 months

    gender, race/ethnicity; insurance type; highest level education; school/employment status; total household income

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Acronym: EPICS

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Feb 9, 2021
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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