Clinical Trials Directory

Trials / Completed

CompletedNCT02362750

Evaluating Cancer Survivorship Care Models

Status
Completed
Phase
Study type
Observational
Enrollment
991 (actual)
Sponsor
George Washington University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
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.

Timeline

Start date
2013-07-01
Primary completion
2016-10-01
Completion
2016-10-01
First posted
2015-02-13
Last updated
2026-03-25
Results posted
2026-03-25

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02362750. Inclusion in this directory is not an endorsement.