Head and Neck Cancer Clinical Trial
Official title:
Feasibility Study of the Head and Neck Survivorship Tool: Assessment and Recommendations (HN-STAR)
NCT number | NCT02571673 |
Other study ID # | 15-245 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 5, 2015 |
Est. completion date | February 15, 2023 |
Verified date | February 2023 |
Source | Memorial Sloan Kettering Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center | Columbia University, Hartford Hospital |
United States,
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 |
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