Patient and Provider Initiated Survivorship Care Planning

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Other)

Overall Status

Completed

CT.gov ID

NCT02405819

Collaborator

Genentech, Inc. (Industry), WellPoint, Inc. (Industry)

Enrollment

Locations

Arms

Duration (Months)

20.5

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Other: 'My Care Plan' Other: 'Survivorship Care Plan Builder'	N/A

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:

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?

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?

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 Design

Study Type:

Interventional

Actual Enrollment :

41 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Patient and Provider Initiated Survivorship Care Planning: a Randomized Pilot Study

Study Start Date :

Feb 1, 2015

Actual Primary Completion Date :

Feb 1, 2016

Actual Study Completion Date :

Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: Patient Directed We will collect baseline data, including sociodemographic information for the patients and an assessment of each patient's baseline supportive care needs and knowledge about survivorship care. Sociodemographic information will be self completed. All other data collection will be interviewer administered. The instruments used at baseline and follow-up are adapted from previously published surveys (Hodgkinson et al, 2007; Sprague et al, 2013; Griggs et al). The research team will direct patients to their assigned condition by providing a hand-out directing them to the planning tool. After 2 months, we will re-contact all randomized patients to determine whether the survivorship care planning occurred as intended.	Other: 'My Care Plan' 'My Care Plan' is a patient-initiated survivorship care planning tool.
Other: Clinician Directed We will collect baseline data, including sociodemographic information for the patients and an assessment of each patient's baseline supportive care needs and knowledge about survivorship care. Sociodemographic information will be self completed. All other data collection will be interviewer administered. The instruments used at baseline and follow-up are adapted from previously published surveys (Hodgkinson et al, 2007; Sprague et al, 2013; Griggs et al). The provider will be provided a hand-out with their patient's assigned condition and is responsible for implementing the survivorship care plan process. After 2 months, we will re-contact all randomized patients to determine whether the survivorship care planning occurred as intended.	Other: 'Survivorship Care Plan Builder' 'Survivorship Care Plan Builder' is a provider-initiated survivorship care planning tool.

Arm

Intervention/Treatment

Other: Patient Directed

We will collect baseline data, including sociodemographic information for the patients and an assessment of each patient's baseline supportive care needs and knowledge about survivorship care. Sociodemographic information will be self completed. All other data collection will be interviewer administered. The instruments used at baseline and follow-up are adapted from previously published surveys (Hodgkinson et al, 2007; Sprague et al, 2013; Griggs et al). The research team will direct patients to their assigned condition by providing a hand-out directing them to the planning tool. After 2 months, we will re-contact all randomized patients to determine whether the survivorship care planning occurred as intended.

Other: 'My Care Plan'

'My Care Plan' is a patient-initiated survivorship care planning tool.

Other: Clinician Directed

We will collect baseline data, including sociodemographic information for the patients and an assessment of each patient's baseline supportive care needs and knowledge about survivorship care. Sociodemographic information will be self completed. All other data collection will be interviewer administered. The instruments used at baseline and follow-up are adapted from previously published surveys (Hodgkinson et al, 2007; Sprague et al, 2013; Griggs et al). The provider will be provided a hand-out with their patient's assigned condition and is responsible for implementing the survivorship care plan process. After 2 months, we will re-contact all randomized patients to determine whether the survivorship care planning occurred as intended.

Other: 'Survivorship Care Plan Builder'

'Survivorship Care Plan Builder' is a provider-initiated survivorship care planning tool.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Have you diagnosed with non-metastatic (i.e., stages I - III) cancer (non-melanoma skin cancer)
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)
What clinician primarily managed your cancer treatment? (must be a participating Sibley or Suburban clinician)