Clinical trial NCT02405819: Patient and Provider Initiated Survivorship Care Planning
Official title: Patient and Provider Initiated Survivorship Care Planning: a Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Cancer
Oncology
Survivorship
Care
Plan
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
name: WellPoint, Inc.
First posted: 2015-04-01
Enrollment: 41
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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?

Primary outcomes:
measure: Patient in receipt of a complete survivorship care plan
timeFrame: 16 weeks
Secondary outcomes:
measure: Change in score for the CaSUN (Cancer Survivors' Unmet Needs) assessment tool
timeFrame: 16 weeks
measure: Change in score on the PLANS (Preparing for Life as a New Survivor) assessment tool
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: Sibley Memorial Hospital
state: District of Columbia
city: Bethesda
country: United States
facility: Suburban Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Katherine C Smith, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Griggs, J. et al. PLANS ("Preparing for Life as a New Survivor")
citation: Hodgkinson K, Butow P, Hunt GE, Pendlebury S, Hobbs KM, Lo SK, Wain G. The development and evaluation of a measure to assess cancer survivors' unmet supportive care needs: the CaSUN (Cancer Survivors' Unmet Needs measure). Psychooncology. 2007 Sep;16(9):796-804. doi: 10.1002/pon.1137.
citation: Sprague BL, Dittus KL, Pace CM, Dulko D, Pollack LA, Hawkins NA, Geller BM. Patient satisfaction with breast and colorectal cancer survivorship care plans. Clin J Oncol Nurs. 2013 Jun;17(3):266-72. doi: 10.1188/13.CJON.17-03AP.
citation: Smith KC, Tolbert E, Hannum SM, Radhakrishnan A, Zorn K, Blackford A, Greco S, Smith K, Snyder CF. Comparing Web-Based Provider-Initiated and Patient-Initiated Survivorship Care Planning for Cancer Patients: A Randomized Controlled Trial. JMIR Cancer. 2016 Aug 30;2(2):e12. doi: 10.2196/cancer.5947.