The Engaging Primary Care in Cancer Survivorship (EPICS) Study
- Conditions
- Breast CancerColorectal Cancer
- Interventions
- Other: Embedded primary care in cancer survivorship model
- Registration Number
- NCT04745754
- Lead Sponsor
- Kaiser Permanente
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 2450
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Condition Embedded primary care in cancer survivorship model 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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).
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).
Primary Care Delivery of Survivorship Care Scale 12 months Self-reported measure of perceived survivorship care (6 questions; response options: 5-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? _______________
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).
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)
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.
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)
Trial Locations
- Locations (13)
Kaiser Permanente Baldwin Park Medical Center Oncology Clinic
🇺🇸Baldwin Park, California, United States
Kaiser Permanente Orange County Anaheim/Irvine Medical Center Oncology Clinics
🇺🇸Anaheim, 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, United States