- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02405819
Patient and Provider Initiated Survivorship Care Planning
Patient and Provider Initiated Survivorship Care Planning: a Randomized Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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District of Columbia
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Washington, District of Columbia, United States, 20016
- Sibley Memorial Hospital
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Maryland
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Bethesda, Maryland, United States, 20814
- Suburban Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
1. Do you show any evidence of disease?
Study Plan
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.
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'My Care Plan' is a patient-initiated survivorship care planning tool.
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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.
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'Survivorship Care Plan Builder' is a provider-initiated survivorship care planning tool.
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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.
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16 weeks
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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
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The change in score on the CaSUN tool will be used to asses the value of survivorship care planning.
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16 weeks
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Change in score on the PLANS (Preparing for Life as a New Survivor) assessment tool
Time Frame: 16 weeks
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The change in score on the PLANS tool will be used to asses the value of survivorship care planning.
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16 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Katherine C Smith, Ph.D., Johns Hopkins Bloomberg School of Public Health
Publications and helpful links
General Publications
- Griggs, J. et al. PLANS ("Preparing for Life as a New Survivor")
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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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