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| Name | Class |
|---|---|
| Columbia University | OTHER |
| Hartford Hospital | OTHER |
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Aim 1: Part 1
Aim 1: Part 2
Exclusion Criteria:
Aim 1: Parts 1 and 2 is the same
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Clinics
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| Name | Affiliation | Role |
|---|---|---|
| Talya Salz, PhD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hartford Healthcare Cancer Institute @ Hartford Hospital | Hartford | Connecticut | 06102 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27965842 | Derived | 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. |
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Survivors of Head and Neck Cancer | Participants must have completed treatment for head and neck cancer at least 1 year prior to survivorship visit and have no evidence of disease. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Survivors of Head and Neck Cancer | Participants must have completed treatment for head and neck cancer at least 1 year prior to survivorship visit and have no evidence of disease. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | % of pts w/accurate TS for primary site | 2 years |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Survivors of Head and Neck Cancer | Participants must have completed treatment for head and neck cancer at least 1 year prior to survivorship visit and have no evidence of disease. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Talya Salz, PhD | Memorial Sloan Kettering Cancer Center | 646-227-3646 | salzt@mskcc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 15, 2018 | Oct 10, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 14, 2016 | Jun 24, 2020 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| Memorial Sloan Kettering Cancer Center |
| New York |
| New York |
| 10065 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 0 |
| 65 |
| 0 |
| 65 |
| 0 |
| 65 |
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