Feasibility Study of the Head and Neck Survivorship Tool: Assessment and Recommendations (HN-STAR)

Study Overview
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Brief Summary
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This study is being done to understand how survivors of head and neck cancer think they can make HN-STAR (the Survivor Self-Assessment, the survivorship clinic experience, and the Survivorship Care Plan the best it can be. Once the investigators have your input and input from other survivors, they can make changes to HN-STAR, so that they can test this tool in a larger study. The larger study will tell them whether using HN-STAR improves the care of head and neck cancer survivors.

Official Title
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Feasibility Study of the Head and Neck Survivorship Tool: Assessment and Recommendations (HN-STAR)

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Behavioral: Assessments


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aim 1: Part 1 Have completed treatment for head and neck cancer at least 1 year prior to survivorship visit and have no evidence of disease Have a primary care provider Be able to provide informed consent Be able to speak and read English Be at least 18 years old Aim 1: Part 2 Have completed treatment for head and neck cancer at least 1 year prior to survivorship visit and have no evidence of disease Have a primary care provider Be able to provide informed consent Be able to speak and read English Be at least 18 years old Exclusion Criteria: Aim 1: Parts 1 and 2 is the same Patients or providers who cannot speak or read English Patients with cognitive, visual, or motor impairment such that they cannot complete the Survivor Self-Assessment as assessed by the research team.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Survivors of head and neck cancer<br>Data collection will take place in two parts. Aim 1: Part 1 will enroll 10 patients at MSK to participate in component pilot testing and usability testing of HN-STAR and the associated surveys. We will also elicit feedback from the NP. After incorporating any changes to HN-STAR or the surveys based on findings from Aim 1: Part 1, Aim 1: Part 2 will enroll 30 additional patients from MSK and 15 from HH to provide feedback on usability. We will also survey each patient's PCP in Aim 1: Part 2. | Behavioral: Assessments<br>* Usability outcomes will come from patient surveys and interviews and a nurse practitioner interview in Aim 1: Part 1. In Aim 1: Part 2, patients and their primary care providers will complete online surveys regarding feasibility. Health outcomes and data regarding health care actions will be collected from HN-STAR and the clinic note will be collected to assess feasibility of collecting these metrics in a future trial. Directly after each clinic visit, the NP will complete one brief online survey for each participant.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recommendations for cancer surveillance (patient-reported outcomes from the Survivor Self-Assessment) | Using data from survivors in Aim 1: Part 2 (N=45), we will abstract data on health care actions from both the medical record and HN-STAR. Such data include receipt of appropriate oncologic surveillance, identification and management of symptoms, and appropriate preventive health services, as indicated by referrals, prescriptions, and recommendations in both clinic notes and the HN-STAR Survivor Self-Assessment. This Aim will determine the feasibility of data collection, establish baseline health status measures, and contribute to power calculations for the future trial. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Survivorship, Quality of Life, HN-STAR web-based, 15-245