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.

Treatment Sites in Georgia

Phoebe Cancer Center at Phoebe Putney Memorial Hospital
425 Third Avenue
Albany, GA 31702
229-312-5091
www.phoebehealth.com

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.