Clinical trial NCT03035773: Simplifying Survivorship Care Planning
Official title: Simplifying Survivorship Care Planning; Comparing the Efficacy and Patient-Centeredness of Three Care Delivery Models
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Oncology
Survivorship
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2017-01-30
Enrollment: 378
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: OBJECTIVE: The purpose of this study is to identify an SCP process that is patient-centered, effective in promoting appropriate survivorship care and can be successfully implemented for patients with different types of cancer who are being treated in a broad range of clinical settings. There is a need for research related to SCP that prioritizes outcomes that are most highly valued by patients, caregivers and clinical stakeholders.

Detailed description: BACKGROUND: Each year, approximately 1.6 million people are diagnosed with cancer and the relative 5-year survival rate across all cancer types approaches 70%. As of 2014, there were almost 15 million Americans living with a history of cancer. Cancer survivors face a variety of health care needs, including surveillance for recurrence, treatment for long-term and late effects of cancer and its treatment, general primary and preventive care, management of any comorbidities, encouragement of healthy lifestyle behaviors, and attention to psychosocial issues. In 2005, the Institute of Medicine (IOM) report 'From Cancer Patient to Cancer Survivor: Lost in Transition' highlighted the challenges that cancer survivors face as they transition from acute treatment. The completion of acute cancer treatment is a critical juncture at which patients are in need of better support and communication to ensure optimal health and quality of life outcomes as they transition to long-term survivorship. Cancer survivors face substantial deficiencies in the quality of care that they receive, including both underuse of recommended care and overuse of services that are not recommended for routine follow-up. The 2005 IOM report called for all patients completing acute treatment to be provided with a survivorship care plan (SCP) that summarizes treatments received and outlines future healthcare priorities in order to facilitate effective management of health care between survivors and their oncology and primary care providers.

STUDY PROCEDURES: The primary aim of this trial is to assess whether there is a difference among three SCP models of varying levels of resource intensity and patients' receipt of recommended health services in the months following completion of acute treatment. The investigators will conduct a randomized controlled trial (RCT) to measure whether the provision of the SCP to the survivor and primary care provider (PCP) is associated with survivors' receipt of cancer follow-up care as outlined on their SCP (primary outcome). Avoidance of non-recommended care, receipt of recommended primary and preventive care, and patient-reported outcome measures will serve as secondary endpoints.

Participants in the RCT will have been treated for breast, prostate, or colorectal cancer. This RCT will be conducted in four oncology clinics in two medical systems. The investigators will enroll survivors of Stage I-III breast, prostate, or colorectal cancer who are completing treatment and transitioning to long-term survivorship, and use a stratified randomization to assign participants to one of three study conditions (Arms A, B or C). This study will focus specifically on the period following completion of acute treatment (e.g., surgery, radiation, and chemotherapy); patients receiving long-term adjuvant endocrine/antibody therapies will also be eligible.

The proposed trial will be conducted at Johns Hopkins Medical Institution (JHMI) and Peninsula Regional Medical Center (PRMC). JHMI is a large, academic medical center in an urban setting with distinct treatment programs based on disease site. At JHMI, the investigators will recruit from the Breast Cancer Program, the Genitourinary Cancer Program (prostate cancer), and Gastrointestinal Cancer Program (colorectal cancer). These programs operate across disciplines (e.g., medical, radiation, and surgical oncology) but separately from each other, enabling evaluation of 3 separate clinical settings within JHMI. In addition, the trial will include the PRMC Richard A. Henson Cancer Institute, a community cancer program located in the rural area of Maryland's eastern shore. At PRMC there is a single general oncology practice. The four programs differ in the extent to which survivorship care planning is already a part of routine care. As yet, none of the clinics in this study has a consistent format for the delivery of SCP universally at the completion of acute treatment. The study design (cancer types, clinical systems and SCP models) is intended to enable the development of real-world best practices for the implementation of SCPs and assess whether these are consistent or vary across a wide range of clinical contexts and survivor characteristics.

Each participant will be followed for 18 months, with the number of visits dependent on the randomization arm (described below). The investigators will abstract 18 months of follow-up data for enrolled patients from medical records, as well as from patient reports of health service use; data will be collected at months 6, 12, and 18. The investigators will obtain and abstract medical records guided by the information in the summary document (see Health Services Use Summary included as a supplemental study document) and from the patient using provided tracking tools of providers they have seen, tests they have undergone, etc. (see Tip Sheet in supplemental study documents). Patient-reported outcomes will be collected at baseline, 6, 12, and 18 months primarily via a REDCap form, with telephone or in-person data collection as a back-up when needed.

Eligibility criteria: Inclusion Criteria:

* Age 21 years or older;
* Diagnosed with breast, colorectal, or prostate cancer (stages I-III);
* Treated with intent to cure
* People who are on long-term (\>1 year) chronic treatment are eligible;
* No evidence of disease;
* Able to complete the study data collection in English;
* Had their cancer care primarily managed by either JHMI or PRMC, with JHMI or PRMC primarily responsible for the patients' survivorship care; and
* Has private insurance, or covered by Medicare or Medicaid.

Exclusion Criteria:

* Younger than 21 years of age;
* Diagnosed with in situ or metastatic breast, prostate or colorectal cancer (i.e. Stage 0 or IV);
* Not treated with intent to cure;
* Did not have cancer care primarily managed within one of the 4 participating clinics, or JHMI or PRMC is not primarily responsible for the patients' survivorship care; and
* Does not have health insurance at screening.

Primary outcomes:
measure: Number of Participants Compliant With Follow-up Care Visits
timeFrame: 18 Months
Secondary outcomes:
measure: Number of Participants Who Received an Annual Physical Exam
timeFrame: 18 Months
measure: Number of Participants Who Received Tests and Procedures Recommended on Their Survivorship Care Plan
timeFrame: 18 Months
measure: Number of Participants Who Received Cancer-related Tests Consistent With Overuse
timeFrame: 18 Months
measure: Patient-reported Outcomes: Preparing for Life as a (New) Survivor (PLANS)
timeFrame: 18 Months
measure: Patient-reported Outcomes: Assessment of Survivor Concerns (ASC)
timeFrame: 18 Months
measure: Patient-reported Outcomes: Follow-up Care Use Among Survivors (FOCUS)-Information Needs Module
timeFrame: 18 Months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: Salisbury
country: United States
facility: Peninsula Regional Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Katherine C Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beckjord EB, Arora NK, McLaughlin W, Oakley-Girvan I, Hamilton AS, Hesse BW. Health-related information needs in a large and diverse sample of adult cancer survivors: implications for cancer care. J Cancer Surviv. 2008 Sep;2(3):179-89. doi: 10.1007/s11764-008-0055-0. Epub 2008 Jun 3.
citation: Dunn, R., Crowley, S., & Janz, N. (2011). Impact of a transition visit on addressing quality of life and readiness to assume greater self-management among breast cancer survivors. Psycho-Oncology, 20(S1), S91.
citation: Gotay CC, Pagano IS. Assessment of Survivor Concerns (ASC): a newly proposed brief questionnaire. Health Qual Life Outcomes. 2007 Mar 13;5:15. doi: 10.1186/1477-7525-5-15.
citation: Hershman DL, Greenlee H, Awad D, Kalinsky K, Maurer M, Kranwinkel G, Brafman L, Jayasena R, Tsai WY, Neugut AI, Crew KD. Randomized controlled trial of a clinic-based survivorship intervention following adjuvant therapy in breast cancer survivors. Breast Cancer Res Treat. 2013 Apr;138(3):795-806. doi: 10.1007/s10549-013-2486-1. Epub 2013 Mar 31.
citation: Hewitt, M., Greenfield, S., & Stovall, E. (Eds.). (2005). From cancer patient to cancer survivor: lost in transition. National Academies Press.
citation: Kent EE, Arora NK, Rowland JH, Bellizzi KM, Forsythe LP, Hamilton AS, Oakley-Girvan I, Beckjord EB, Aziz NM. Health information needs and health-related quality of life in a diverse population of long-term cancer survivors. Patient Educ Couns. 2012 Nov;89(2):345-52. doi: 10.1016/j.pec.2012.08.014. Epub 2012 Sep 28.
citation: Mallinger JB, Griggs JJ, Shields CG. Patient-centered care and breast cancer survivors' satisfaction with information. Patient Educ Couns. 2005 Jun;57(3):342-9. doi: 10.1016/j.pec.2004.09.009.
citation: Nelson DE, Kreps GL, Hesse BW, Croyle RT, Willis G, Arora NK, Rimer BK, Viswanath KV, Weinstein N, Alden S. The Health Information National Trends Survey (HINTS): development, design, and dissemination. J Health Commun. 2004 Sep-Oct;9(5):443-60; discussion 81-4. doi: 10.1080/10810730490504233.
citation: Smith KC, Tolbert E, Hannum SM, Radhakrishnan A, Zorn K, Blackford A, Greco S, Smith K, Snyder CF. Comparing Web-Based Provider-Initiated and Patient-Initiated Survivorship Care Planning for Cancer Patients: A Randomized Controlled Trial. JMIR Cancer. 2016 Aug 30;2(2):e12. doi: 10.2196/cancer.5947.