Evaluating Cancer Survivorship Care Models
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- George Washington University
- Enrollment
- 991
- Locations
- 1
- Primary Endpoint
- Percentage of Survivors Reporting "Yes Definitely" Across Items Within Each of 9 Factors Reflecting Survivorship Care Quality
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
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.
Intervention: Consultative Specialized Survivorship Clinic (CSSC) (Other)
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.
Intervention: Longitudinal Specialized Survivorship Clinic (LSSC) (Other)
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.
Intervention: Oncology Embedded Survivorship Clinic (OESC) (Other)
Outcomes
Primary Outcomes
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.
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 Percentage
Time Frame: Patients 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 Score
Time Frame: 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.
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 Visit
Time Frame: Patients 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Richard Lush
Principle Investigator
George Washington University