The Engaging Primary Care in Cancer Survivorship (EPICS) Study

Breast Cancer Clinical Trial

— EPICS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04745754
• Other study ID #: R01CA249419
• Secondary ID: 1R01CA249419-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 21, 2021
• Est. completion date: May 31, 2025

Study information

• Verified date: October 2023
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2450
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Kaiser Permanente Orange County Anaheim/Irvine Medical Center Oncology Clinics	Anaheim	California
United States	Kaiser Permanente Baldwin Park Medical Center Oncology Clinic	Baldwin Park	California
United States	Kaiser Permanente Downey/Bellflower Medical Center Oncology Clinics	Downey	California
United States	Kaiser Permanente Fontana Medical Center Oncology Clinic	Fontana	California
United States	Kaiser Permanente South Bay Medical Center Oncology Clinic	Harbor City	California
United States	Kaiser Permanente Kern County Medical Facilities Oncology Clinic	Kern	California
United States	Kaiser Permanente Antelope Valley Medical Center Oncology Clinic	Lancaster	California
United States	Kaiser Permanente Los Angeles Medical Center Oncology Clinic	Los Angeles	California
United States	Kaiser Permanente West Lost Angeles Medical Center Oncology Clinic	Los Angeles	California
United States	Kaiser Permanente Panorama City Medical Center Oncology Clinic	Panorama City	California
United States	Kaiser Permanente Riverside/Palm Springs Medical Center Oncology Clinics	Riverside	California
United States	Kaiser Permanente San Diego Medical Center Oncology Clinics	San Diego	California
United States	Kaiser Permanente Woodland Hills Medical Center Oncology Clinic	Woodland Hills	California

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-reported patient demographics	gender, race/ethnicity; insurance type; highest level education; school/employment status; total household income	12 months
Primary	Cancer surveillance care services	Receipt of guideline-recommended cancer surveillance care services.	36 months
Primary	Preventive care services	Receipt of guideline-recommended preventive care services.	36 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Primary Care Delivery of Survivorship Care Scale	Self-reported measure of perceived survivorship care (6 questions; response options: 5-item Likert scale)	12 months
Secondary	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
Secondary	The Satisfaction with Decision Scale	(6 questions; response options: 4-item Likert Scale)	12 months
Secondary	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
Secondary	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