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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02571673
• Other study ID #: 15-245
• Status: Completed
• Start date: October 5, 2015
• Est. completion date: February 15, 2023

Study information

• Verified date: February 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: February 15, 2023
• Est. primary completion date: February 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Behavioral:
• Assessments
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.

Locations

Country	Name	City	State
United States	Hartford Healthcare Cancer Institute @ Hartford Hospital	Hartford	Connecticut
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Columbia University, Hartford Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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. 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.	2 years

External Links

•   Memorial Sloan Kettering Cancer Center