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TerminatedNCT02530112Updated Apr 11, 2025

Functional Outcome Measures for Head and Neck Patients

An observational study in Otorhinolaryngology Subjects Undergoing Free Flap Surgery, sponsored by Abramson Cancer Center at Penn Medicine. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-11.

Sponsored by Abramson Cancer Center at Penn Medicine · Observational

Why this study was terminated
The study proved very difficult to do on paper surveys. The health system is now doing these via the chart with more success.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Otorhinolaryngology Subjects Undergoing Free Flap Surgery
03

In context

Lead sponsor

Abramson Cancer Center at Penn Medicine is the lead sponsor of 446 studies on the registry; 86 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 14 (44%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • No children, pregnant women, or prisoners will be consented.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Phase 1

    First round of survey respondents.

    Other: Survey

  • Phase 2

    Second round of survey respondents.

    Other: Survey

  • Phase 3

    Third round of survey respondents.

    Other: Survey

Interventions

  • OtherSurvey
06

What researchers measure

Primary outcomes

  1. Completion of Survey

    Completion of quality of life surveys.

    Time frame: 9 years

07

Study locations

1 site
  • Abramson Cancer Center of the University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02530112
Lead sponsor
Abramson Cancer Center at Penn Medicine
Responsible party
Sponsor
First posted
Aug 20, 2015
Start date
Feb 2, 2014
Primary completion
Dec 2024
Completion
Dec 2024
Last update
Apr 11, 2025

Study contacts

Steven Cannady, MD
principal investigator · Abramson Cancer Center at Penn Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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