Patient and Provider Initiated Survivorship Care Planning

Not Applicable

Completed

• Conditions: Cancer

• Registration Number: NCT02405819
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary

Objective: to describe and compare the implementation of two cancer survivorship care tools: (1) 'My Care Plan': a patient-initiated tool and (2) 'Survivorship Care Plan Builder': a provider-initiated tool. The results of this study will be used to (1) provide an initial assessment of the two survivorship care planning tools and (2) inform the design and conduct of a larger study.

Detailed Description

Background/Rationale: In a 2005 report 'From Cancer Patient to Cancer Survivor: Lost in Transition', the Institute of Medicine recommended that cancer patients completing treatment receive a summary of the care received and a plan outlining follow-up care needs. Taken together these materials are referred to as a 'Survivorship Care Plan', or SCPs. Based on this recommendation from the IOM, a number of organizations developed survivorship care plan templates. Two of these templates, 'Survivorship Care Plan Builder' and 'My Care Plan,' were developed by Journey Forward, a collaboration among the National Coalition for Cancer Survivorship, UCLA Cancer Survivorship Center, Oncology Nursing Society, WellPoint, Inc., and Genentech (http://journeyforward.org/). These tools are available free of charge to those wishing to use them. As the time and effort required to complete SCP documents have been found to be barriers to implementation, this study aims to explore the use of these two tools.

Research Questions:

1. What processes are undertaken to implement survivorship care planning?

* How do these processes differ between the patient-initiated My Care Plan and provider-initiated Survivorship Care Plan Builder?

2. What is the feasibility of implementing survivorship care planning?

* Does the feasibility differ between the patient-initiated My Care Plan and provider-initiated Survivorship Care Plan Builder?

3. What is the value of survivorship care planning to both patients and providers?

* Does the value differ between the patient-initiated My Care Plan and provider-initiated Survivorship Care Plan Builder?

Study Design: This is a pilot randomized study. Cancer patients completing acute treatment with a participating provider will be randomized to either the patient-initiated My Care Plan tool or provider-initiated Survivorship Care Plan Builder. The investigators will describe and compare how each tool is implemented in practice, the feasibility of completing each tool, and the value of the tools to patients and providers. The study will use quantitative and qualitative measures of implementation, feasibility, and value.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-03-13
• Study First Submitted QC: 2015-03-31
• Study First Posted: 2015-04-01
• Status Verified: 2015-11
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Last Update Submitted: 2016-04-20
• Last Update Posted: 2016-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

1. Have you diagnosed with non-metastatic (i.e., stages I - III) cancer (non-melanoma skin cancer)
2. Have you completed acute treatment with intent to cure within the past 2 months (ongoing long-term maintenance therapy such as adjuvant hormonal therapy is allowed)
3. What clinician primarily managed your cancer treatment? (must be a participating Sibley or Suburban clinician)

Exclusion Criteria

1. Do you show any evidence of disease?

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient in receipt of a complete survivorship care plan	16 weeks	As this study explores the feasibility of the survivorship care planning process, the primary outcome measure is whether or not the patient receives a complete survivorship care plan.

Secondary Outcome Measures

Name	Time	Method
Change in score for the CaSUN (Cancer Survivors' Unmet Needs) assessment tool	16 weeks	The change in score on the CaSUN tool will be used to asses the value of survivorship care planning.
Change in score on the PLANS (Preparing for Life as a New Survivor) assessment tool	16 weeks	The change in score on the PLANS tool will be used to asses the value of survivorship care planning.

Trial Locations

Locations (2)

Sibley Memorial Hospital; 🇺🇸 Washington, District of Columbia, United States

Suburban Hospital; 🇺🇸 Bethesda, Maryland, United States