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

Completed

• Conditions: Head and Neck Cancer
• Interventions: Behavioral: Assessments

• Registration Number: NCT02571673
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-05
• Study First Submitted: 2015-10-06
• Study First Submitted QC: 2015-10-06
• Study First Posted: 2015-10-08
• Status Verified: 2023-02
• Primary Completion: 2023-02-15
• Study Completion: 2023-02-15
• Results First Submitted: 2023-10-10
• Results First Submitted QC: 2023-10-10
• Last Update Submitted: 2023-10-10
• Results First Posted: 2024-04-15
• Last Update Posted: 2024-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Survivors of head and neck cancer	Assessments	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.

Primary Outcome Measures

Name	Time	Method
Recommendations for Cancer Surveillance (Patient-reported Outcomes From the Survivor Self-Assessment)	2 years	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. For each participant, HN-STAR generates a Treatment Summary/TS for the clinician to review and verify its accuracy compared with clinical documentation with the participant medical record.

Trial Locations

Locations (2)

Hartford Healthcare Cancer Institute @ Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States