Functional Outcome Measures for Head and Neck Patients

Terminated

• Conditions: Otorhinolaryngology Subjects Undergoing Free Flap Surgery
• Interventions: Other: Survey

• Registration Number: NCT02530112
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2014-02-02
• Study First Submitted: 2015-08-19
• Study First Submitted QC: 2015-08-19
• Study First Posted: 2015-08-20
• Status Verified: 2023-08
• Primary Completion: 2024-12
• Study Completion: 2024-12
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Phase 1	Survey	First round of survey respondents.
Phase 2	Survey	Second round of survey respondents.
Phase 3	Survey	Third round of survey respondents.

Primary Outcome Measures

Name	Time	Method
Completion of Survey	9 years	Completion of quality of life surveys.

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States