Head and Neck Cancer
Conditions
Keywords
Survivorship, Quality of Life, HN-STAR web-based, 15-245
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.
Interventions
BEHAVIORALAssessments
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.
Sponsors
Columbia University
Hartford Hospital
Memorial Sloan Kettering Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recommendations for Cancer Surveillance (Patient-reported Outcomes From the Survivor Self-Assessment) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 65 |
| Total | 65 |
Baseline characteristics
| Characteristic | Survivors of Head and Neck Cancer |
|---|---|
| Age, Continuous | 60 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 65 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 57 Participants |
| Region of Enrollment United States | 65 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 65 |
| other Total, other adverse events | 0 / 65 |
| serious Total, serious adverse events | 0 / 65 |
Outcome results
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.
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Survivors of Head and Neck Cancer | Recommendations for Cancer Surveillance (Patient-reported Outcomes From the Survivor Self-Assessment) | 93 % of pts w/accurate TS for primary site |