Evaluating Cancer Survivorship Care Models

The Evaluating Cancer Survivorship Care Models project is an innovative 3-year study that is collecting data to help understand how to best deliver follow-up care to cancer survivors. Cancer is a complex disease requiring complex treatments that can cause lasting impacts after treatment ends. Some patients face physical, psychosocial, spiritual and/or practical challenges as they adjust to life after cancer. Fortunately, health care providers have begun to focus on the consequences of cancer and its treatment and are more actively working with cancer survivors to manage post-treatment needs and care.

Led by the George Washington University and funded by the Patient-Centered Outcomes Research Institute, this project brings together representatives from the Commission on Cancer, the Cancer Support Community, LIVESTRONG and the American Cancer Society as well as cancer survivors and healthcare professionals to better understand how different strategies or models of care impact outcomes that are most important to cancer survivors. The project will focus on survivors of breast, prostate and colorectal cancers and will be relevant for understanding the needs and preferences of survivors of other cancers as well. The emphasis is on patient-centered outcomes, which are outcomes that are most significant to patients, such as patient satisfaction and quality of life.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Cancer
• Intervention / Treatment: Other: Consultative Specialized Survivorship Clinic (CSSC); Other: Longitudinal Specialized Survivorship Clinic (LSSC); Other: Oncology Embedded Survivorship Clinic (OESC)

Detailed Description

Evaluating Cancer Survivorship Care Models Study Overview and Research Design

Cancer is a complex disease requiring complex treatments that can cause lasting impacts after treatment ends. Some patients face lasting physical, psychosocial, spiritual and/or practical challenges as they adjust to life after cancer. Fortunately, health care clinicians have begun to focus on the consequences of cancer and its treatment and are more actively working with cancer survivors to manage post-treatment needs and care.

The Evaluating Cancer Survivorship Care Models project is a groundbreaking 3-year comparative effectiveness research (CER) study that examines how to best deliver follow-up care to cancer survivors. This project is led by the George Washington University and funded by the Patient-Centered Outcomes Research Institute. A key component of the project is the use of a stakeholder Advisory Board chaired by a cancer survivor who serves as a senior advisor to the research team. The Advisory Board includes survivors, survivor advocates, clinicians, health care professionals and advisors from stakeholders across myriad facets of cancer care, including the Cancer Support Community, LIVESTRONG, the Commission on Cancer, and the American Cancer Society. These organizations are critical to the success of the project.

The study is innovative in its focus on patient-centered outcomes. The first phase of the project employed a mixed methods approach including a secondary analysis of existing data from 4 national surveys, focus groups with cancer survivors, an environmental scan of existing survivorship programs and a national survey of cancer survivors to develop an outcomes tool and a prospective observational CER study. Based on results from the first phase, the study team at the George Washington University (GW) developed a patient-prioritized index to identify services and components of care that patients equate with high quality survivorship care.

Three models of survivorship care at Commission on Cancer-accredited institutions were identified through the environmental scan. In the CER phase of the study, each survivorship care model will serve as a comparator for the other two models. Patients in the CER study population will be adults who have been diagnosed with non-metastatic breast, prostate or colorectal cancer and completed active treatment. Patient-reported outcomes will be assessed at three points in the project: at baseline (immediately prior to and immediately following a post-treatment survivorship visit), 3 months post-visit and 6 months post-visit. Multivariable analyses including repeated measures and mixed-effect regression modeling will be used to control for systematic differences across the groups, which would further increase the validity of our results. Using the newly-developed index, the comparative effectiveness study will measure the quality of programs according to what patients have identified as most important to them.

The investigators have launched the CER phase of the study and are enrolling high-performing survivorship programs. Our pool of invited participants consists of Commission on Cancer-accredited sites with clinical survivorship care programs that meet the following eligibility criteria:

• Provide services to survivors of breast, prostate or colorectal cancer
• Have demonstrated a high performance level on incorporating elements of survivorship care into clinical care delivery
• See at least 60 new survivors yearly
• Includes the most common characteristics related to delivery of survivorship care

During the CER study, data will be gathered from survivorship program administrators, patients and survivorship care clinicians. Survivorship program administrators will complete an interview and survey to examine how survivorship programs are organized and identify key characteristics of programs to determine which factors are most influential in delivering high quality post-treatment survivorship care. Patients will complete surveys measuring patient-centered outcomes: health-related quality of life; self-efficacy; satisfaction; health care utilization and a newly developed measure of quality of survivorship care as prioritized by patients. Clinicians will complete surveys on the services offered during participating patients' initial post-treatment survivorship visit. Together, this data will allow the GW study team to understand successful strategies for transforming the care delivery system to be more responsive to patient needs.

In the third and final phase, this project will generate critical data for a variety of decision-makers related to care for post-treatment cancer survivors and will result in evidence-based guidance for how to organize and deliver post-treatment care. The GW study team seeks to provide recommendations on survivorship care delivery best practices; develop tools for improving survivorship programs and care delivery from both clinician and patient perspectives; and to widely disseminate findings to a variety of stakeholders, including survivors and their families, clinicians, survivorship care program leaders, payers, policymakers and others.

• Study Type: Observational
• Enrollment (Actual): 991

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20036
      • The George Washington University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult survivors of breast, prostate or colorectal cancer who received treatment and are scheduled for post-treatment survivorship services at a cancer program enrolled in the CER as a recruitment site.

Description

Inclusion criteria

• English-speaking survivors of non-metastatic breast, prostate or colorectal cancers
• Completed active treatment (chemotherapy, radiation, and/or surgery), but may be on hormonal medication, aromatase inhibitors or other maintenance therapy
• Diagnosed at 18 years old or older
• First survivorship care appointment has been scheduled but not completed
• Be a patient at one of the high-performing cancer programs selected to participate in the CER study

Exclusion criteria

• Diagnosed with cancer other than breast, prostate or colorectal cancer
• Not English-speaking
• Currently undergoing active treatment (defined as chemotherapy, radiation, and/or surgery)
• Cancer has metastasized
• Diagnosed at under 18 years old
• Have completed first appointment with the survivorship program
• Not a patient at one of the high-performing cancer programs selected to participate in the CER study

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cancer Survivors in CSSC Models; Non-metastatic breast, prostate and colorectal cancer survivors receiving survivorship care through a Consultative Specialized Survivorship Clinic (CSSC) with Direct Access. This model provides consultative survivorship care after treatment has ended through a single visit dedicated specifically to survivorship. The majority of Tier 1 Essential Elements, including the survivorship care plan (SCP), psychosocial care, health promotion services and symptom management, are provided through direct access during the survivorship visit. This model is typically led by a nurse practitioner (NP) or physician's assistant (PA) with specialized training.	Other: Consultative Specialized Survivorship Clinic (CSSC); CORE COMPONENTS: Provides most Tier 1 Essential Elements directly through a dedicated survivorship visit. Services include the survivorship care plan, psychosocial care, health promotion services and symptom management. This model typically: 1) has a nurse practitioner or physicians assistant as patients' primary point of contact, 2) has organizational support via dedicated resources, senior management buy-in and quality improvement activities; 3) bills for survivorship services; 4) systematizes care coordination with other clinicians; and 5) provides referrals for screenings for new cancers/recurrences and surveillance for cancer and the impacts of treatment. It is the most likely of the three models to transition patients fully back to their primary care providers.
Cancer Survivors in LSSC Models; Non-metastatic breast, prostate and colorectal cancer survivors receiving survivorship care through a Longitudinal Specialized Survivorship Clinic (LSSC) with Direct Access. This model provides ongoing survivorship care through a series of survivorship-specific visits scheduled at predetermined intervals and as needed by the patient. The majority of Tier 1 essential elements are provided through direct access onsite rather than through a referral, including the SCP, surveillance for impacts of treatment, screenings for new cancers/recurrences, health promotion education, psychosocial care and symptom management. This model is typically led by an NP or a PA.	Other: Longitudinal Specialized Survivorship Clinic (LSSC); CORE COMPONENTS: Delivers most Tier 1 Essential Elements directly through a series of dedicated visits at planned intervals and as patient needs. Services include the SCP, surveillance for impacts of treatment, screenings for new cancers/recurrences, health promotion education, psychosocial care and symptom management. This model typically: 1) introduces survivorship care during treatment; 2) is led by an NP or a PA who is patients' primary point of contact; 3) engages comprehensive provider teams with input from oncologists, social workers, nutritionists and pharmacists; and 4) is likely to have moderate senior management commitment and dedicated resources. This model is less likely to bill for survivorship services and have care coordination protocols to transition patients back to PCP than the Consultative Specialized model.
Cancer Survivors in OESC Models; Non-metastatic breast, prostate and colorectal cancer survivors receiving survivorship care through Oncology Embedded Survivorship Clinics (OESC) with Varied Access. This model provides survivorship care as part of standard post-treatment oncology follow-up care. Because this model integrates survivorship with standard follow-up care, it is considered a longitudinal model, though institutions also report survivorship is not always provided systematically as in Model 2 but rather on an as needed basis at the request of the patient. Institutions with the Embedded model are more likely to use referrals to deliver some of the key survivorship services than either of the other two models. Survivorship care in this model is typically provided by the treating oncologist often with support from an NP/PA, patient navigator or social worker.	Other: Oncology Embedded Survivorship Clinic (OESC); CORE COMPONENTS: Integrates survivorship care with standard treatment and post-treatment follow-up care on on-going basis as patient needs, often through referral. Services are likely to begin before the end of treatment, typically by the treating oncologist with support from an NP/PA, patient navigator or social worker who is patients' primary point of contact. Responsibility for SCP development and delivery varies. There is no dedicated survivorship care team in this model; instead the treatment team takes on this responsibility. This model is less likely to enjoy dedicated resources, have commitment from senior management, and bill for survivorship services. This model is also less likely to systematize care coordination with other clinicians, and oncologists in this model rarely release their patients fully to their PCPs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Survivors Reporting "Yes Definitely" Across Items Within Each of 9 Factors Reflecting Survivorship Care Quality	Patient-reported quality of care was measured using the Survivorship Care Quality Index, which consists of 9 factors and a total of 46 metrics. The factors are then grouped into domains. Domain 1, Informed and grounded patients, consist of 2 factors: 1) delivering mental health and social support, and 2) providing information and resources on the expectations of survivorship care. Domain 2, the patient-provider alliance, consists of 3 factors: 1) feeling empowered to engage in their care, 2) having supportive and respectful clinicians, and 3) having meaningful communication between the patient and clinician. Domain 3, a supportive health and wellness system, consists of 5 factors: 1) coordinating care across providers, 2) preparing patients for transitions in care, 3) having access to a full spectrum of care, 4) providing practical life support, and 5) making sure patients belong to a medical home during this phase of their care.	Patients complete a survey within one week after their survivorship visit, and 6 months post visit.
Average Number of Quality of Life Top Concerns Reported Converted to a Percentage	Patient-reported quality of life concerns were measured using an index with 3 factors that represent physical concerns (consists of 8 metrics), social and emotional concerns (6 metrics), and practical concerns (2 metrics). The prevalence of top concerns in each domain were calculated. The top concerns were defined as those with >40% prevalence at baseline across all three models. For physical concerns individuals received scores ranging from 0/8 to 8/8, for social/emotional concerns individuals were scored 0/6 to 6/6, and for practical concerns they were scored 0/2 to 2/2. The number presented is the average of those individual scores, converted into a percentage. The higher the number the more concerns participants reported	Patients complete a survey at baseline before their survivorship visit, and 6 months post visit.
Self- Efficacy Score	Patient-reported self-efficacy was measured as the mean score of 8 metrics, reflecting how confident patients are that they can take care of different aspects of their health and health care after treatment has ended on a scale from 0 to 5, where 0=not at all confident and 5=totally confident.	Patients complete a survey at baseline before their survivorship visit, within one week after their survivorship visit, 3 months post visit, and 6 months post visit.
Frequency of Visit	Number of visits to health care providers at 3 different time points: end of treatment- baseline pre-survivorship visit, 0-3 months and 3-6 months post survivorship visit. The data presented are the mean (SD) number of visits to specific providers over time, by model.	Patients complete a survey at baseline before their survivorship visit, 3 months post visit, and 6 months post visit.

Collaborators and Investigators

• Sponsor: George Washington University
• Investigators: Principal Investigator: K. Holly Mead, PhD, The George Washington University

Publications and helpful links

General Publications

• Mead KH, Wang Y, Cleary S, Arem H, Pratt-Chapman ML. Defining a patient-centered approach to cancer survivorship care: development of the patient centered survivorship care index (PC-SCI). BMC Health Serv Res. 2021 Dec 18;21(1):1353. doi: 10.1186/s12913-021-07356-6.

Helpful Links

• Viswanathan M, Halpern M, Swinson Evans T, et al. Models of Cancer Survivorship Care [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2014 Mar. (Technical Briefs, No. 14.)
• Evaluating Cancer Survivorship Care Models Project Website
• American Cancer Society. Cancer Treatment and Survivorship Facts & Figures 2012-2013. Atlanta: American Cancer Society; 2012.
• Hewitt M, Greenfield S, Stovall E. (2005). From Cancer Patient to Cancer Survivor: Lost in Transition. Washington, D.C.: The National Academies Press.
• American College of Surgeons' Commission on Cancer. Cancer program standards 2012: ensuring patient-centered care. Accessed December 12, 2012.
• Rechis R, Beckjord EB, Arvey SR, Reynolds KA, McGoldrick D. The Essential Elements of Survivorship Care: A Brief. 2011. Accessed December 12, 2012.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: January 21, 2015
• First Submitted That Met QC Criteria: February 9, 2015
• First Posted (Estimated): February 13, 2015

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: survivorship; comparative effectiveness; Patient-Centered Outcomes Research
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: IH-12-11-5255