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Functional Outcome Measures for Head and Neck Patients

NCT ID: NCT02530112

Last Updated: 2025-04-11

Study Results

Results pending

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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Recruitment Status

TERMINATED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-02

Study Completion Date

2024-12-31

Brief Summary

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The objective of this study is to identify outcome measures for cancer control in Head and Neck cancer patient populations at the University of Pennsylvania (HUP, PAH, Presby) by administering various functional outcome surveys and questionnaires about their reconstructive surgery. We hope to ultimately develop a QOL indicator that will reflect the impact of reconstructive surgery on patient's quality of life, and help with therapeutic interventions and explanation of expectations prior to surgery.

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Detailed Description

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Few studies examine quality of life outcome measures with initial diagnosis, surgical procedures,perioperative measures (such as use of perioperative blood transfusion or pressors), and outcomes for cancer control and free flap survival. This sub-protocol, in conjunction with protocol #816676 (Otorhinolaryngology Research Registry) will serve as a hypothesis generating study for future research on reconstructive free flap surgery outcomes by narrowing down existing questionnaires to tailor it specifically for these patients.

Conditions

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Otorhinolaryngology Subjects Undergoing Free Flap Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Phase 1

First round of survey respondents.

Survey

Intervention Type OTHER

Phase 2

Second round of survey respondents.

Survey

Intervention Type OTHER

Phase 3

Third round of survey respondents.

Survey

Intervention Type OTHER

Interventions

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Survey

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subjects who have consented to Otorhinolaryngology Research Registry and are undergoing free flap surgery.

Exclusion Criteria

* No children, pregnant women, or prisoners will be consented.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven Cannady, MD

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Locations

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Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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UPCC 17913

Identifier Type: -

Identifier Source: org_study_id

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