Clinical trial · Observational
Feasibility Study of the Head and Neck Survivorship Tool: Assessment and Recommendations (HN-STAR)
NCT02571673CI-TRIAL-00076044completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Assessments | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Survivors of head and neck cancer
- description
- 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.
- interventionNames
- Behavioral: Assessments
Primary outcomes (1)
- measure
- Recommendations for Cancer Surveillance (Patient-reported Outcomes From the Survivor Self-Assessment)
- timeFrame
- 2 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDSalz 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