Simplifying Survivorship Care Planning

Not Applicable

Completed

Conditions: Cancer

Interventions: Behavioral: Care Plan Only
Behavioral: Care Plan During a Visit
Behavioral: Care Plan During a Visit with an Additional Visit

Registration Number: NCT03035773

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 378

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ARM A; Care Plan Only	Care Plan Only	SCP document delivered to the patient \& Primary Care Provider
ARM B; Care Plan During Visit	Care Plan During a Visit	SCP document provided to the patient in an in-person survivorship visit and copy sent to PCP
ARM C; Care Plan During Visit + Additional Visit	Care Plan During a Visit with an Additional Visit	SCP document provided to the patient in an in-person survivorship visit with an additional follow-up visit and copy of the document sent to PCP

Primary Outcome Measures

Name	Time	Method
Number of Participants Compliant With Follow-up Care Visits	18 Months	The primary outcome classifies patients as compliant or non-compliant based on whether they were compliant on all visits, tests/procedures, and non-oral medication recommendations included in their care plans.

Secondary Outcome Measures

Name	Time	Method
Patient-reported Outcomes: Follow-up Care Use Among Survivors (FOCUS)-Information Needs Module	18 Months	Questionnaire asking about informational needs on 12 topics. Responses for each question can be yes/no/not sure. Reported the total number of health needs responded to as "yes". Outcome is a sum of reported needs. Score range from 0-12 with a higher score reflecting more informational needs.
Number of Participants Who Received Tests and Procedures Recommended on Their Survivorship Care Plan	18 Months	These data are generated through electronic medical record review. This outcome is operationalized as a dichotomous variable (received recommended tests and procedures: yes/no).
Number of Participants Who Received an Annual Physical Exam	18 Months	This secondary outcome classifies participants as having had an annual physical exam based on medical record review. This outcome was operationalized as a dichotomous variable (received recommended primary care: yes/no). Participants were included in this analysis if they had a primary care visit recommended on their survivorship care plan.
Patient-reported Outcomes: Preparing for Life as a (New) Survivor (PLANS)	18 Months	PLANS is a cancer survivorship questionnaire with 2 items specifically related to survivorship care planning. These items are 'I feel prepared for what to expect over the next year' (score range 1-4 with 4 being a more positive score) and 'There is a well-coordinated plan for my cancer care' (score range 1-10 with 1 being "Not at all confident and 10 being "Extremely confident".
Patient-reported Outcomes: Assessment of Survivor Concerns (ASC)	18 Months	The outcome is a sum score of a 5-item scale with a minimum score of 5 and a maximum score of 20 with a higher score indicating greater worry (worse outcome).
Number of Participants Who Received Cancer-related Tests Consistent With Overuse	18 Months	This analysis compared potential overuse of surveillance tests between cancer types (breast, prostate and colorectal). This outcome will be operationalized as a dichotomous variable (did not receive inappropriate care: yes/no). The outcome relates to participants who received care not specified on their care plan and on a guideline predetermined list of "not recommended surveillance. This was determined through a physician chart review.

Trial Locations

Locations (2): Peninsula Regional Medical Center
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Salisbury, Maryland, United States
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Baltimore, Maryland, United States