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OpenTrials
Completed

NCT Number: NCT02405819

Patient and Provider Initiated Survivorship Care Planning

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sibley Memorial Hospital, Washington D.C., District of Columbia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Exclusion criteria

  • Do you show any evidence of disease?

Treatment and study plan

'My Care Plan'

Other

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

'Survivorship Care Plan Builder'

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Collaborators

  • Genentech, Inc.
  • WellPoint, Inc.

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 1, 2015
Registry last updated
Apr 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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