Breast CancerEPICSNCT04745754
The Engaging Primary Care in Cancer Survivorship (EPICS) Study
A study testing Embedded primary care in cancer survivorship model in people with Breast Cancer and Colorectal Cancer, run by Kaiser Permanente at 13 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Breast Cancer, Colorectal Cancer
- What is being tested?
- Embedded primary care in cancer survivorship model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,450 participants
- Where
- 13 sitesUnited States
- Study dates
- 21 Sep 2021to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Kaiser Permanente Orange County Anaheim/Irvine Medical Center Oncology Clinics
Anaheim, California, 92806
Kaiser Permanente Baldwin Park Medical Center Oncology Clinic
Baldwin Park, California, 91706
Kaiser Permanente Downey/Bellflower Medical Center Oncology Clinics
Downey, California, 90242
Kaiser Permanente Fontana Medical Center Oncology Clinic
Fontana, California, 92335
Kaiser Permanente South Bay Medical Center Oncology Clinic
Harbor City, California, 90710
Kaiser Permanente Kern County Medical Facilities Oncology Clinic
Kern, California, 93306
Kaiser Permanente Antelope Valley Medical Center Oncology Clinic
Lancaster, California, 93534
Kaiser Permanente Los Angeles Medical Center Oncology Clinic
Los Angeles, California, 90027
Kaiser Permanente West Lost Angeles Medical Center Oncology Clinic
Los Angeles, California, 90034
Kaiser Permanente Panorama City Medical Center Oncology Clinic
Panorama City, California, 91402
Kaiser Permanente Riverside/Palm Springs Medical Center Oncology Clinics
Riverside, California, 92505
Kaiser Permanente San Diego Medical Center Oncology Clinics
San Diego, California, 92123
Kaiser Permanente Woodland Hills Medical Center Oncology Clinic
Woodland Hills, California, 91367
About this study
Official title: The EPICS (Engaging Primary Care in Cancer Survivorship) Study: A Trial of Novel Models of Care for Cancer Survivors
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.
Read the 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.
- Conditions
- Breast Cancer, Colorectal Cancer
- Being tested
- Embedded primary care in cancer survivorship model
- Keywords
- Cancer survivorship, Models of care
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embedded primary care in cancer survivorship modelOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Condition | Experimental | 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. Receives: Other: Embedded primary care in cancer survivorship model |
| Control Condition | No intervention | Usual care for breast and colorectal cancer survivors (oncology-led model). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer surveillance care services
Receipt of guideline-recommended cancer surveillance care services.
Measured: 36 months
Preventive care services
Receipt of guideline-recommended preventive care services.
Measured: 36 months
Secondary outcomes (12)
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.
Measured: 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)
Measured: 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).
Measured: 12 months
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).
Measured: 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).
Measured: 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)
Measured: 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).
Measured: 12 months
Primary Care Delivery of Survivorship Care Scale
Self-reported measure of perceived survivorship care (6 questions; response options: 5-item Likert scale)
Measured: 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)
Measured: 12 months
The Satisfaction with Decision Scale
(6 questions; response options: 4-item Likert Scale)
Measured: 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).
Measured: 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? _______________
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start21 Sep 2021
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 2,450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Erin E. Hahn, Kaiser Permanente
- Investigators
- Erin E. Hahn, PhD, MPH, Principal investigator, Kaiser Permanente Southern California, Department of Research & Evaluation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04745754
- Sponsor's protocol ID
- R01CA249419
- Other IDs
- 1R01CA249419-01
- Acronym
- EPICS
- Status last verified
- Dec 2025
- First submitted
- 25 Jan 2021
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The EPICS (Engaging Primary Care in Cancer Survivorship) Study: A Trial of Novel Models of Care for Cancer Survivors
- ClinicalTrials.gov ID
- NCT04745754
- Acronym / sponsor ID
- EPICS / R01CA249419
- Conditions
- Breast Cancer, Colorectal Cancer
- Keywords
- Cancer survivorship, Models of care
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,450 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 21 Sep 2021 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 9 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Condition | Experimental | Other: Embedded primary care in cancer survivorship modelThe 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. |
| Control Condition | No intervention | –Usual care for breast and colorectal cancer survivors (oncology-led model). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Embedded primary care in cancer survivorship modelPrimacy 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. | Other | Intervention Condition |
Primary outcome
Cancer surveillance care services
Time frame: 36 months
Receipt of guideline-recommended cancer surveillance care services.
Preventive care services
Time frame: 36 months
Receipt of guideline-recommended preventive care services.
12 secondary outcomes
Non-recommended surveillance care/non-planned emergency 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)
Time frame: 12 months
Patient-Centered Medical Home (PCMH) and Cancer Consumer Assessment of Healthcare Providers and Systems (CAHPS)
Time frame: 12 months
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale v1.2 (answer responses using a 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)
Time frame: 12 months
The European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (version 3)
Time frame: 12 months
Receipt of Treatment Summary from Health Information and National Trends Survey (HINTS 4, Cycle 2)
Time frame: 12 months
Primary Care Delivery of Survivorship Care Scale
Time frame: 12 months
Patient-Reported Bother from Side Effects of Cancer Therapy (Validated Single-Item Measure)
Time frame: 12 months
The Satisfaction with Decision Scale
Time frame: 12 months
Confidence in Managing Survivorship Care
Time frame: 12 months
Cancer recurrence
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin E. Hahn, PhD, MPH principal investigator
Kaiser Permanente Southern California, Department of Research & Evaluation
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embedded primary care in cancer survivorship model in people with Breast Cancer and Colorectal Cancer, run by Kaiser Permanente at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer surveillance care services (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.