The Engaging Primary Care in Cancer Survivorship (EPICS) Study

Sponsor

Kaiser Permanente (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04745754

Collaborator

National Cancer Institute (NCI) (NIH)

2,450

Enrollment

Locations

Arms

44.3

Anticipated Duration (Months)

188.5

Patients Per Site

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Colorectal Cancer	Other: Embedded primary care in cancer survivorship model	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

2450 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 21, 2021

Anticipated Primary Completion Date :

May 31, 2024

Anticipated Study Completion Date :

May 31, 2025

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

Cancer surveillance care services [36 months]
Receipt of guideline-recommended cancer surveillance care services.
Preventive care services [36 months]
Receipt of guideline-recommended preventive care services.

Secondary Outcome Measures

Non-recommended surveillance care/non-planned emergency and urgent care services [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.
Medical Expenditure Panel Survey (MEPS) 2016, Experiences with Cancer Supplement, Section 7, Medical Care for Cancer Module (Item #44) [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)
Patient-Centered Medical Home (PCMH) and Cancer Consumer Assessment of Healthcare Providers and Systems (CAHPS) [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).
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale v1.2 (answer responses using a Likert Scale) [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).
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]
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).
The European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (version 3) [12 months]
Questionnaire developed to assess the quality of life of cancer patients (30 questions; response options: 4-item or 7-item Likert scale)
Receipt of Treatment Summary from Health Information and National Trends Survey (HINTS 4, Cycle 2) [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).
Primary Care Delivery of Survivorship Care Scale [12 months]
Self-reported measure of perceived survivorship care (6 questions; response options: 5-item Likert scale)
Patient-Reported Bother from Side Effects of Cancer Therapy (Validated Single-Item Measure) [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)
The Satisfaction with Decision Scale [12 months]
(6 questions; response options: 4-item Likert Scale)
Confidence in Managing Survivorship Care [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).
Cancer recurrence [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 Outcome Measures

Self-reported patient demographics [12 months]
gender, race/ethnicity; insurance type; highest level education; school/employment status; total household income

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaiser Permanente Orange County Anaheim/Irvine Medical Center Oncology Clinics	Anaheim	California	United States	92806
2	Kaiser Permanente Baldwin Park Medical Center Oncology Clinic	Baldwin Park	California	United States	91706
3	Kaiser Permanente Downey/Bellflower Medical Center Oncology Clinics	Downey	California	United States	90242
4	Kaiser Permanente Fontana Medical Center Oncology Clinic	Fontana	California	United States	92335
5	Kaiser Permanente South Bay Medical Center Oncology Clinic	Harbor City	California	United States	90710
6	Kaiser Permanente Kern County Medical Facilities Oncology Clinic	Kern	California	United States	93306
7	Kaiser Permanente Antelope Valley Medical Center Oncology Clinic	Lancaster	California	United States	93534
8	Kaiser Permanente Los Angeles Medical Center Oncology Clinic	Los Angeles	California	United States	90027
9	Kaiser Permanente West Lost Angeles Medical Center Oncology Clinic	Los Angeles	California	United States	90034
10	Kaiser Permanente Panorama City Medical Center Oncology Clinic	Panorama City	California	United States	91402
11	Kaiser Permanente Riverside/Palm Springs Medical Center Oncology Clinics	Riverside	California	United States	92505
12	Kaiser Permanente San Diego Medical Center Oncology Clinics	San Diego	California	United States	92123
13	Kaiser Permanente Woodland Hills Medical Center Oncology Clinic	Woodland Hills	California	United States	91367

Sponsors and Collaborators

Kaiser Permanente
National Cancer Institute (NCI)

Investigators

Principal Investigator: Erin E. Hahn, PhD, MPH, Kaiser Permanente Southern California, Department of Research & Evaluation

Study Documents (Full-Text)

Study Protocol and Statistical Analysis Plan - Jul 12, 2022

More Information

Publications

None provided.

Responsible Party:

Erin E. Hahn, Research Scientist I, Kaiser Permanente

ClinicalTrials.gov Identifier:

NCT04745754

Other Study ID Numbers:

R01CA249419
1R01CA249419-01

First Posted:

Feb 9, 2021

Last Update Posted:

Aug 23, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Erin E. Hahn, Research Scientist I, Kaiser Permanente

Cancer survivorship

Models of care

Additional relevant MeSH terms:

Colorectal Neoplasms

Study Results

No Results Posted as of Aug 23, 2022