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

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.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hartford Healthcare Cancer Institute @ Hartford Hospital, Hartford, Connecticut, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Assessments

Behavioral

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.

Primary outcomes

Recommendations for Cancer Surveillance (Patient-reported Outcomes From the Survivor Self-Assessment)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

Columbia University
Hartford Hospital

Registry information

Important dates

Study start: 2015
Primary completion: 2023
Study completion: 2023
First posted: Oct 8, 2015
Registry last updated: Apr 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed