search
Back to results

The Engaging Primary Care in Cancer Survivorship (EPICS) Study (EPICS)

Primary Purpose

Breast Cancer, Colorectal Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Embedded primary care in cancer survivorship model
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring Cancer survivorship, Models of care

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Condition

Control Condition

Arm Description

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.

Usual care for breast and colorectal cancer survivors (oncology-led model).

Outcomes

Primary Outcome Measures

Cancer surveillance care services
Receipt of guideline-recommended cancer surveillance care services.
Preventive care services
Receipt of guideline-recommended preventive care services.

Secondary Outcome Measures

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.
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)
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).
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).
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).
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)
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).
Primary Care Delivery of Survivorship Care Scale
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)
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
(6 questions; response options: 4-item Likert Scale)
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).
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? _______________

Full Information

First Posted
January 25, 2021
Last Updated
October 11, 2023
Sponsor
Kaiser Permanente
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT04745754
Brief Title
The Engaging Primary Care in Cancer Survivorship (EPICS) Study
Acronym
EPICS
Official Title
The EPICS (Engaging Primary Care in Cancer Survivorship) Study: A Trial of Novel Models of Care for Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 21, 2021 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaiser Permanente
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Colorectal Cancer
Keywords
Cancer survivorship, Models of care

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Condition
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Condition
Arm Type
No Intervention
Arm Description
Usual care for breast and colorectal cancer survivors (oncology-led model).
Intervention Type
Other
Intervention Name(s)
Embedded primary care in cancer survivorship model
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cancer surveillance care services
Description
Receipt of guideline-recommended cancer surveillance care services.
Time Frame
36 months
Title
Preventive care services
Description
Receipt of guideline-recommended preventive care services.
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Non-recommended surveillance care/non-planned emergency and urgent care services
Description
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
Title
Medical Expenditure Panel Survey (MEPS) 2016, Experiences with Cancer Supplement, Section 7, Medical Care for Cancer Module (Item #44)
Description
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
Title
Patient-Centered Medical Home (PCMH) and Cancer Consumer Assessment of Healthcare Providers and Systems (CAHPS)
Description
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
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale v1.2 (answer responses using a Likert Scale)
Description
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
Title
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)
Description
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
Title
The European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (version 3)
Description
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
Title
Receipt of Treatment Summary from Health Information and National Trends Survey (HINTS 4, Cycle 2)
Description
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
Title
Primary Care Delivery of Survivorship Care Scale
Description
Self-reported measure of perceived survivorship care (6 questions; response options: 5-item Likert scale)
Time Frame
12 months
Title
Patient-Reported Bother from Side Effects of Cancer Therapy (Validated Single-Item Measure)
Description
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
Title
The Satisfaction with Decision Scale
Description
(6 questions; response options: 4-item Likert Scale)
Time Frame
12 months
Title
Confidence in Managing Survivorship Care
Description
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
Title
Cancer recurrence
Description
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
Other Pre-specified Outcome Measures:
Title
Self-reported patient demographics
Description
gender, race/ethnicity; insurance type; highest level education; school/employment status; total household income
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin E. Hahn, PhD, MPH
Organizational Affiliation
Kaiser Permanente Southern California, Department of Research & Evaluation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Orange County Anaheim/Irvine Medical Center Oncology Clinics
City
Anaheim
State/Province
California
ZIP/Postal Code
92806
Country
United States
Facility Name
Kaiser Permanente Baldwin Park Medical Center Oncology Clinic
City
Baldwin Park
State/Province
California
ZIP/Postal Code
91706
Country
United States
Facility Name
Kaiser Permanente Downey/Bellflower Medical Center Oncology Clinics
City
Downey
State/Province
California
ZIP/Postal Code
90242
Country
United States
Facility Name
Kaiser Permanente Fontana Medical Center Oncology Clinic
City
Fontana
State/Province
California
ZIP/Postal Code
92335
Country
United States
Facility Name
Kaiser Permanente South Bay Medical Center Oncology Clinic
City
Harbor City
State/Province
California
ZIP/Postal Code
90710
Country
United States
Facility Name
Kaiser Permanente Kern County Medical Facilities Oncology Clinic
City
Kern
State/Province
California
ZIP/Postal Code
93306
Country
United States
Facility Name
Kaiser Permanente Antelope Valley Medical Center Oncology Clinic
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Kaiser Permanente Los Angeles Medical Center Oncology Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Kaiser Permanente West Lost Angeles Medical Center Oncology Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90034
Country
United States
Facility Name
Kaiser Permanente Panorama City Medical Center Oncology Clinic
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Facility Name
Kaiser Permanente Riverside/Palm Springs Medical Center Oncology Clinics
City
Riverside
State/Province
California
ZIP/Postal Code
92505
Country
United States
Facility Name
Kaiser Permanente San Diego Medical Center Oncology Clinics
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Kaiser Permanente Woodland Hills Medical Center Oncology Clinic
City
Woodland Hills
State/Province
California
ZIP/Postal Code
91367
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Engaging Primary Care in Cancer Survivorship (EPICS) Study

We'll reach out to this number within 24 hrs