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Evaluating Cancer Survivorship Care Models

Evaluating Cancer Survivorship Care Models

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02362750
Enrollment
991
Registered
2015-02-13
Start date
2013-07-01
Completion date
2016-10-01
Last updated
2026-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Quality of Life

Keywords

comparative effectiveness, survivorship, Patient-Centered Outcomes Research

Brief 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. 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.

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.

Interventions

OTHERConsultative 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.

OTHERLongitudinal 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.

OTHEROncology 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.

Sponsors

George Washington University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Survivors Reporting "Yes Definitely" Across Items Within Each of 9 Factors Reflecting Survivorship Care QualityPatients complete a survey within one week after their survivorship visit, and 6 months post visit.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.
Average Number of Quality of Life Top Concerns Reported Converted to a PercentagePatients complete a survey at baseline before their survivorship visit, and 6 months post visit.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
Self- Efficacy ScorePatients 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.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.
Frequency of VisitPatients complete a survey at baseline before their survivorship visit, 3 months post visit, and 6 months post 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORK. Holly Mead, PhD

The George Washington University

Participant flow

Recruitment details

3 models of survivorship care were identified from the environmental scan of Commission on Cancer-accredited institutions. "High performing institutions" (in quality of care) were recruited from the Assoc, of Community Cancer Centers' and GW Cancer Institute's listservs across the three models model. Institutions recruited participants from their own survivorship care programs. 991 survivors were enrolled at baseline.

Baseline characteristics

Characteristic
Age, Continuous60.3 years
STANDARD_DEVIATION 11.6
Cancer site
Breast
295 participants
Cancer site
Colorectal
23 participants
Cancer site
Prostate
48 participants
Education
4-yr college grad
236 Participants
Education
Grad school degree
149 Participants
Education
High school/GED grad or less
131 Participants
Education
Missing
0 Participants
Education
Some college/2-yr degree
74 Participants
Employment Status
Missing
1 Participants
Employment Status
Not working (including retired and disabled)
88 Participants
Employment Status
Self-Employed
20 Participants
Employment Status
Working (as paid employee)
149 Participants
Income
<$25,000
178 participants
Income
<$25,000 -$74,999
109 participants
Income
$75,000+
296 participants
Marital Status
Divorced/Separated
29 participants
Marital Status
Married/Living with Partner
651 participants
Marital Status
Widowed
95 participants
Race/Ethnicity, Customized
Black
84 Participants
Race/Ethnicity, Customized
Ethnicity: Hispanic
25 Participants
Race/Ethnicity, Customized
Ethnicity: Non-Hispanic
203 Participants
Race/Ethnicity, Customized
Other
21 Participants
Race/Ethnicity, Customized
unknown/missing
6 Participants
Race/Ethnicity, Customized
White
313 Participants
Receiving Hormone Therapy
Completed/ will start
31 Participants
Receiving Hormone Therapy
Currently receiving
569 Participants
Receiving Hormone Therapy
Missing
15 Participants
Receiving Hormone Therapy
No (have not and will not)
126 Participants
Recurrence or Diagnosis of New Cancer
At 3 months
5 participants
Recurrence or Diagnosis of New Cancer
At 6 months
6 participants
Sex/Gender, Customized
Female
198 Participants
Sex/Gender, Customized
male
133 Participants
Sex/Gender, Customized
Missing
1 Participants
Stage of Cancer Diagnosis
Don't know
40 Participants
Stage of Cancer Diagnosis
Missing
5 Participants
Stage of Cancer Diagnosis
Stage 0 - cancer in situ; the cancer is still in the place it started
37 Participants
Stage of Cancer Diagnosis
Stage 1 - cancer that has not grown deeply into nearby tissue
133 Participants
Stage of Cancer Diagnosis
Stage 2 - cancer has grown deeply into nearby tissue
92 Participants
Stage of Cancer Diagnosis
Stage 3 - cancer has grown deeply into nearby tissue and may have spread to lymph nodes
20 Participants
Stage of Cancer Diagnosis
Stage 4 - cancer has metasticized and spread to other organs or parts of the body
2 Participants
Treatments Completed
Chemotherapy, target therapy or immunotherapy
138 participants
Treatments Completed
Other
13 participants
Treatments Completed
Radiation
139 participants
Treatments Completed
Surgery
850 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 4120 / 2050 / 374
other
Total, other adverse events
0 / 4120 / 2050 / 374
serious
Total, serious adverse events
0 / 4120 / 2050 / 374

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026