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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
2,450
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.
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
Cancer surveillance care services
Receipt of guideline-recommended cancer surveillance care services.
Time frame: 36 months
Preventive care services
Receipt of guideline-recommended preventive care services.
Time frame: 36 months
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.
Time frame: 36 months
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)
Time frame: 12 months
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).
Time frame: 12 months
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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
...and 3 more locations
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).
Time frame: 12 months
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).
Time frame: 12 months
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)
Time frame: 12 months
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).
Time frame: 12 months
Primary Care Delivery of Survivorship Care Scale
Self-reported measure of perceived survivorship care (6 questions; response options: 5-item Likert scale)
Time frame: 12 months
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)
Time frame: 12 months
The Satisfaction with Decision Scale
(6 questions; response options: 4-item Likert Scale)
Time frame: 12 months
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).
Time frame: 12 months
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? \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Time frame: 12 months