Patient Preferences in Making Treatment Decisions in Patients With Stage I-IVA Oropharyngeal Cancer
NCT ID: NCT01949740
Last Updated: 2015-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
37 participants
OBSERVATIONAL
2013-06-30
2015-08-31
Brief Summary
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Detailed Description
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I. Determine the stability of Head and Neck Priorities Scale (HNPS) ranking between pre- and post-treatment assessments.
SECONDARY OBJECTIVES:
I. Use patient-interviews to refine and modify the HNPS for use in a larger scale trial.
II. Pilot the Head and Neck Patient Outcomes Survey (HNPOS) as a potential tool to identify priorities most important to quality-of-life outcomes.
III. Use the Functional Assessment of Cancer Therapy - Head and Neck (FACT-H\&N) and EurolQoL-5D to determine the validity of the HNPOS.
OUTLINE:
Patients participate in a 45-minute interview comprising assessment of priorities and quality of life at baseline, 1, 6, and 12 months.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Observational (patient preferences)
Patients participate in a 45-minute interview comprising assessment of priorities and quality of life at baseline, 1, 6, and 12 months.
questionnaire administration
Ancillary studies
quality-of-life assessment
Ancillary studies
Interventions
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questionnaire administration
Ancillary studies
quality-of-life assessment
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Sufficient vision, writing, and communication ability to complete the interviews and assessment tool
* Signed informed consent
Exclusion Criteria
* Patients who have previously undergone cancer treatment or are presently undergoing additional cancer treatments
* Patients who have already undergone unsuccessful curative-intent surgery on their head and neck cancer
* Patients, who have had a major surgery (defined as requiring general anesthesia but not including tonsillectomy, neck dissection, or panendoscopy \[triple endoscopy or examination under general anesthesia\]), or significant traumatic injury within 4 weeks of the study; patients who have not recovered from the side effects of any of the above surgeries
* Patients unwilling to or unable to comply with the protocol
* Patients unable to communicate with the interviewer
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Alexander Langerman
Role: PRINCIPAL_INVESTIGATOR
University of Chicago Comprehensive Cancer Center
Locations
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University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Countries
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Other Identifiers
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NCI-2013-01181
Identifier Type: REGISTRY
Identifier Source: secondary_id
IRB13-0552
Identifier Type: -
Identifier Source: secondary_id
13-0552
Identifier Type: -
Identifier Source: org_study_id
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