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Clinical Trials/NCT02571673
NCT02571673CompletedNot Applicable

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

Memorial Sloan Kettering Cancer Center2 sites in 1 country65 target enrollmentStarted: October 5, 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
65
Locations
2
Primary Endpoint
Recommendations for Cancer Surveillance (Patient-reported Outcomes From the Survivor Self-Assessment)

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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.

Outcomes

Primary Outcomes

Recommendations for Cancer Surveillance (Patient-reported Outcomes From the Survivor Self-Assessment)

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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