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Patient and Provider Initiated Survivorship Care Planning

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02405819
Enrollment
41
Registered
2015-04-01
Start date
2015-02-28
Completion date
2016-02-29
Last updated
2016-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Cancer, Oncology, Survivorship, Care, Plan

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.

Interventions

OTHER'My Care Plan'

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

OTHER'Survivorship Care Plan Builder'

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

Sponsors

Genentech, Inc.
CollaboratorINDUSTRY
WellPoint, Inc.
CollaboratorINDUSTRY
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

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?

Design outcomes

Primary

MeasureTime frameDescription
Patient in receipt of a complete survivorship care plan16 weeksAs 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

MeasureTime frameDescription
Change in score for the CaSUN (Cancer Survivors' Unmet Needs) assessment tool16 weeksThe 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 tool16 weeksThe change in score on the PLANS tool will be used to asses the value of survivorship care planning.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026