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

NCT02571673 | Completed Results

• 1 other identifier: 15-245
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 2

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.

Conditions

Head and Neck Cancer

Keywords

Survivorship; Quality of Life; HN-STAR web-based; 15-245

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Survivors of head and neck cancer

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

Interventions

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.

Survivors of head and neck cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Clinics

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Columbia University: collaborator
• Hartford Hospital: collaborator

Study Sites (2)

Hartford Healthcare Cancer Institute @ Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (1)

• Salz T, McCabe MS, Oeffinger KC, Corcoran S, Vickers AJ, Salner AL, Dornelas E, Schnall R, Raghunathan NJ, Fortier E, Baxi SS. A head and neck cancer intervention for use in survivorship clinics: a protocol for a feasibility study. Pilot Feasibility Stud. 2016 May 5;2:23. doi: 10.1186/s40814-016-0061-3. eCollection 2016.

  PMID: 27965842 DERIVED

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Results Point of Contact

• Title: Dr. Talya Salz, PhD
• Organization: Memorial Sloan Kettering Cancer Center

salzt@mskcc.org

646-227-3646

Study Officials

• Talya Salz, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2015
• First Posted: October 8, 2015
• Study Start: October 5, 2015
• Primary Completion: February 15, 2023
• Study Completion: February 15, 2023
• Last Updated: April 15, 2024
• Results First Posted: April 15, 2024

Record last verified: 2023-02

Locations

US (2)