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Quality of LifeNCT02362750

Evaluating Cancer Survivorship Care Models

An observational study of Quality of Life and Cancer, run by George Washington University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Quality of Life, Cancer
What is being tested?
Consultative Specialized Survivorship Clinic (CSSC), Longitudinal Specialized Survivorship Clinic (LSSC) and Oncology Embedded Survivorship Clinic (OESC)
How many people
991 participants
Where
1 siteUnited States
Study dates
Jul 2013to Oct 2016
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • The George Washington University

    Washington D.C., District of Columbia, 20036

Other trials in United States

About this study

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.

Read the 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.

Being tested
Consultative Specialized Survivorship Clinic (CSSC), Longitudinal Specialized Survivorship Clinic (LSSC), Oncology Embedded Survivorship Clinic (OESC)
Keywords
comparative effectiveness, survivorship, Patient-Centered Outcomes Research
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Consultative Specialized Survivorship Clinic (CSSC)Other

    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.

  • Longitudinal Specialized Survivorship Clinic (LSSC)Other

    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.

  • Oncology Embedded Survivorship Clinic (OESC)Other

    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.

Study groups in NCT02362750
Study groupRoleWhat they receive
Cancer Survivors in CSSC ModelsNon-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.
Receives: Other: Consultative Specialized Survivorship Clinic (CSSC)
Cancer Survivors in LSSC ModelsNon-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.
Receives: Other: Longitudinal Specialized Survivorship Clinic (LSSC)
Cancer Survivors in OESC ModelsNon-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.
Receives: Other: Oncology Embedded Survivorship Clinic (OESC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Patients complete a survey within one week after their survivorship visit, and 6 months post visit.

  2. 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

    Measured: Patients complete a survey at baseline before their survivorship visit, and 6 months post visit.

  3. 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.

    Measured: 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.

  4. 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.

    Measured: Patients complete a survey at baseline before their survivorship visit, 3 months post visit, and 6 months post visit.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2015 (estimated)
  2. Study startJul 2013
  3. Primary completionOct 2016
  4. Study completionOct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
991 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02362750
Sponsor's protocol ID
IH-12-11-5255
Status last verified
Mar 2026
First submitted
21 Jan 2015
Last updated
25 Mar 2026
Data monitoring committee
No

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.

    PubMed 34922530

Questions about this trial

What is this clinical trial studying?

An observational study of Quality of Life and Cancer, run by George Washington University at 1 site 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 25 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Survivors Reporting "Yes Definitely" Across Items Within Each of 9 Factors Reflecting Survivorship Care Quality (time frame: Patients complete a survey within one week after their survivorship visit, and 6 months post visit.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02362750, which also lists 1 linked publication.

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 25 Mar 2026.

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