Improving Survivorship Care Through Enhanced Communication and Coordination: Pilot Study

NCT02111616 | Completed

• 1 other identifier: UNC HENC LCCC 1325
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: Cancer survivorship is a high clinical and research priority both nationally and at the University of North Carolina. The investigators propose a randomized pilot study testing the development, implementation and evaluation of a parallel patient and streamlined provider version of a personalized Survivorship Care Plan (SCP) with lung cancer patients. Participants: 60 lung cancer patients at Rex Cancer Center. Procedures (methods): Participants will be recruited and randomized to the standard of care (30 patients) or intervention (30 patients) arm. Patients randomized to standard of care will receive a tailored survivorship care plan at the end of cancer treatment. Patients randomized to the intervention will receive a care plan and coordinating visit with their primary care provider. Patients will be invited to complete baseline and follow-up assessments regarding care needs and confidence in post cancer care. All patient primary care providers will receive condensed provider versions of the care plan. Providers will be asked to evaluate how the SCP and coordinated care visit (intervention only) facilitated communication and coordination of care.

Conditions

Cancer

Keywords

cancer survivorship care; provider communication; provider care coordination

Outcome Measures

Primary Outcomes (1)

• Number of participants with increased patient confidence about Survivorship Care

  To compare the change in confidence about survivorship care between patients who receive a coordinated care visit with their PCP (intervention group) compared to those who do not have this visit (control group). The project will use 8 questionnaires to assess changes in patient and provider confidence and patient concerns over the course of the study. The primary objective in this one year study is to compare changes in Confidence in Survivorship Information Questionnaire (CSI) scores among patients receiving the proposed standard of care survivorship care plan (30 patients) to patients receiving care plans and a coordinated PCP visit (30 patients) to determine whether the delivery of tailored SCPs increases the confidence of survivors in receiving post treatment cancer care.

  Up to six weeks

Secondary Outcomes (2)

• Patient Activation Score

  Up to 6 weeks

• Number of providers with increased confidence about survivorship

  Up to 6 weeks

Study Arms (2)

Standard of Care (SCP)

ACTIVE COMPARATOR

Patient will attend a transition visit at the conclusion of cancer treatment. Patient will receive an individualized cancer survivorship care plan based on their cancer type and treatment.

Behavioral: Survivorship Care Plan (SCP)

Intervention Arm (SCP + PCP visit)

EXPERIMENTAL

Patient will attend a transition visit at the conclusion of cancer treatment. Patient will receive an individualized cancer survivorship care plan based on their cancer type and treatment. SCP plus Coordinated PCP Visit: Care coordinators will schedule patient appointment with PCP within 4 weeks of treatment.

Behavioral: Survivorship Care Plan (SCP); Behavioral: Coordinated PCP visit

Interventions

Survivorship Care Plan (SCP) BEHAVIORAL

Cancer Survivorship Care Plan (SCP) adapted from JourneyForward template. Each SCP is individualized to patient's care regimen. SCP is delivered at the conclusion of cancer treatment and during the patient's transition visit with nurse practitioner or physician assistant.

Intervention Arm (SCP + PCP visit); Standard of Care (SCP)

Coordinated PCP visit BEHAVIORAL

Visit with PCP scheduled on behalf of patient at the conclusion of cancer treatment and patient's transition visit.

Intervention Arm (SCP + PCP visit)

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>21 years
• Able to read and speak English will be eligible to participate
• Diagnosed with a smoking-related cancer (initial accrual priority is lung cancer, followed by head and neck, esophageal and cervical cancer)
• Treated at Rex Cancer Center for cancer
• Completed treatment within the past three months-
• Have a designated primary care provider (PCP)

You may not qualify if:

• patient diagnosed with metastatic cancer

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

Rex Cancer Center

Raleigh, North Carolina, 27607, United States

Location

Related Links

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

MeSH Terms

Conditions

Neoplasms

Study Officials

• Deborah K. Mayer, PhD, RN

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Donald L Rosenstein, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2014
• First Posted: April 11, 2014
• Study Start: December 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: August 1, 2015
• Last Updated: January 20, 2016

Record last verified: 2016-01

Locations

US (1)