Clinical trial NCT04745754: The Engaging Primary Care in Cancer Survivorship (EPICS) Study
Official title: The EPICS (Engaging Primary Care in Cancer Survivorship) Study: A Trial of Novel Models of Care for Cancer Survivors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Colorectal Cancer
Keywords: Cancer survivorship
Models of care
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-02-09
Enrollment: 2450
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cancer surveillance care services
timeFrame: 36 months
measure: Preventive care services
timeFrame: 36 months
Secondary outcomes:
measure: Non-recommended surveillance care/non-planned emergency and urgent care services
timeFrame: 36 months
measure: Medical Expenditure Panel Survey (MEPS) 2016, Experiences with Cancer Supplement, Section 7, Medical Care for Cancer Module (Item #44)
timeFrame: 12 months
measure: Patient-Centered Medical Home (PCMH) and Cancer Consumer Assessment of Healthcare Providers and Systems (CAHPS)
timeFrame: 12 months
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale v1.2 (answer responses using a Likert Scale)
timeFrame: 12 months
measure: 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)
timeFrame: 12 months
measure: The European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (version 3)
timeFrame: 12 months
measure: Receipt of Treatment Summary from Health Information and National Trends Survey (HINTS 4, Cycle 2)
timeFrame: 12 months
measure: Primary Care Delivery of Survivorship Care Scale
timeFrame: 12 months
measure: Patient-Reported Bother from Side Effects of Cancer Therapy (Validated Single-Item Measure)
timeFrame: 12 months
measure: The Satisfaction with Decision Scale
timeFrame: 12 months
measure: Confidence in Managing Survivorship Care
timeFrame: 12 months
measure: Cancer recurrence
timeFrame: 12 months
Other outcomes:
measure: Self-reported patient demographics
timeFrame: 12 months
Locations:
city: Anaheim
country: United States
facility: Kaiser Permanente Orange County Anaheim/Irvine Medical Center Oncology Clinics
state: California
city: Baldwin Park
country: United States
facility: Kaiser Permanente Baldwin Park Medical Center Oncology Clinic
state: California
city: Downey
country: United States
facility: Kaiser Permanente Downey/Bellflower Medical Center Oncology Clinics
state: California
city: Fontana
country: United States
facility: Kaiser Permanente Fontana Medical Center Oncology Clinic
state: California
city: Harbor City
country: United States
facility: Kaiser Permanente South Bay Medical Center Oncology Clinic
state: California
city: Kern
country: United States
facility: Kaiser Permanente Kern County Medical Facilities Oncology Clinic
state: California
city: Lancaster
country: United States
facility: Kaiser Permanente Antelope Valley Medical Center Oncology Clinic
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles Medical Center Oncology Clinic
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente West Lost Angeles Medical Center Oncology Clinic
state: California
city: Panorama City
country: United States
facility: Kaiser Permanente Panorama City Medical Center Oncology Clinic
state: California
city: Riverside
country: United States
facility: Kaiser Permanente Riverside/Palm Springs Medical Center Oncology Clinics
state: California
city: San Diego
country: United States
facility: Kaiser Permanente San Diego Medical Center Oncology Clinics
state: California
city: Woodland Hills
country: United States
facility: Kaiser Permanente Woodland Hills Medical Center Oncology Clinic
state: California
Study officials:
affiliation: Kaiser Permanente Southern California, Department of Research & Evaluation
name: Erin E. Hahn, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: