Evaluating Cancer Survivorship Care Models

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.

Inclusion criteria for the CER component:

Survivorship program administrators oversee survivorship programs which:

- See at least 60 new survivors of non-metastatic breast, prostate or colorectal cancer
or survivors of any type of cancer yearly

- Represent one of the clinical survivorship care models identified in our
environmental scan

- Indicate a high performance level on incorporating elements of survivorship care into
clinical care delivery.

Survivors:

- English-speaking survivors of non-metastatic breast, prostate or colorectal cancers

- Completed planned active treatment (chemotherapy, radiation, and/or surgery) with the
exception of hormonal medication, aromatase inhibitors or other maintenance therapy

- Diagnosed at 18 years old or older

- First appointment with the survivorship program is planned but has not yet been
completed

Survivorship program clinicians:

• Must be providing services for eligible survivors who have completed their first visit
with the survivorship program and are participating in the study.

Exclusion criteria for the CER component:

Survivorship program administrators:

- Programs with fewer than at least 60 new survivors yearly

- Do not provide services to adult survivors of non-metastatic breast, prostate or
colorectal cancer or survivors of any type of cancer

- Do not represent one of the three models of clinical survivorship care as identified
in our environmental scan

- Do not indicate a high performance level on incorporating elements of survivorship
care into clinical care delivery

Survivors:

- Received diagnosis for cancer that was not 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

Men will be excluded from the breast cancer arm of the study. Women will be excluded from
the prostate cancer arm of the study.

Survivorship program clinicians:

• Not providing services for eligible survivors.