Patient and Provider Initiated Survivorship Care Planning

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • District of Columbia
      • Washington, District of Columbia, United States, 20016
        • Sibley Memorial Hospital
    • Maryland
      • Bethesda, Maryland, United States, 20814
        • Suburban Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient in receipt of a complete survivorship care plan
Time Frame: 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.
16 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Katherine C Smith, Ph.D., Johns Hopkins Bloomberg School of Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

March 13, 2015

First Submitted That Met QC Criteria

March 31, 2015

First Posted (Estimate)

April 1, 2015

Study Record Updates

Last Update Posted (Estimate)

April 21, 2016

Last Update Submitted That Met QC Criteria

April 20, 2016

Last Verified

November 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • J14178
  • IRB00057614 (Other Identifier: JHMIRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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