Implementation and Effectiveness of HN-STAR in Managing the Health of Head and Neck Squamous Cell Cancer Survivors

Active:	Yes
Cancer Type:	Head and Neck Cancer	NCT ID:	NCT04208490
Trial Phases:		Protocol IDs:	WF-1805CD (primary) WF-1805CD WF-1805CD NCI-2019-03600
Eligibility:	18 Years and older, Male and Female	Study Type:	Health services research
Study Sponsor:	Wake Forest NCORP Research Base
NCI Full Details:	http://clinicaltrials.gov/show/NCT04208490

Summary

This trial studies how a computer program, the Head and Neck Survivorship Tool: Assessment and Recommendations (HN-STAR) works in helping health care providers care for survivors of head and neck squamous cell cancer. HN-STAR is a type of survivorship tool that survivors and their health care providers may use together to better manage the survivors' health.

Objectives

PRIMARY OBJECTIVE:
I. Evaluate the impact of HN-STAR, compared to controls, on change in patient-centered outcomes from baseline to one-year follow-up.

SECONDARY OBJECTIVES:
I. Evaluate the impact of HN-STAR, compared to controls, on receipt of guideline-concordant care in the year after enrollment, including a visit to a primary care provider in the year following the designated clinic visit.
II. Conduct a robust, mixed methods evaluation of the implementation process, including assessments of survivor, health care provider (oncology and primary care), and organizational barriers and facilitators that may influence integration of HN-STAR in various National Cancer Institute Community Oncology Research Program (NCORP) settings.

OUTLINE: Clinics are randomized to 1 of 2 arms. Patients are assigned to Arm I or II based on clinic randomization.

ARM I: Within 6 months of patient completing treatment, patients meet with the designated clinician for routine clinic visit in accordance with usual care.

ARM II: Within 6 months of patient completing treatment, patients complete a Survivor Health Assessment before meeting with the designated clinician for a clinic visit. Patients receive a survivorship care plan from HN-STAR at the clinic visit that summarizes the patient's cancer history and outlines a plan for ongoing care. Patients then complete Survivor Health Assessments and receive survivorship care plans at 3, 6, and 9 months after clinic visit.

After completion of study, patients are followed up at 1 year.

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