Patient and Provider Initiated Survivorship Care Planning

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02405819
• Other study ID #: J14178
• Secondary ID: IRB00057614
• Status: Completed
• Phase: N/A
• First received: March 13, 2015
• Last updated: April 20, 2016
• Start date: February 2015
• Est. completion date: February 2016

Study information

• Verified date: November 2015
• Source: Sidney Kimmel Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• 'My Care Plan'
'My Care Plan' is a patient-initiated survivorship care planning tool.
• 'Survivorship Care Plan Builder'
'Survivorship Care Plan Builder' is a provider-initiated survivorship care planning tool.

Locations

Country	Name	City	State
United States	Suburban Hospital	Bethesda	Maryland
United States	Sibley Memorial Hospital	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center	Genentech, Inc., WellPoint, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient in receipt of a complete survivorship care plan	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	No
Secondary	Change in score for the CaSUN (Cancer Survivors' Unmet Needs) assessment tool	The change in score on the CaSUN tool will be used to asses the value of survivorship care planning.	16 weeks	No
Secondary	Change in score on the PLANS (Preparing for Life as a New Survivor) assessment tool	The change in score on the PLANS tool will be used to asses the value of survivorship care planning.	16 weeks	No

External Links

•   Journey Forward is a cancer survivorship program for healthcare providers and patients who have finished active treatment.