Functional Outcome Measures for Head and Neck Patients | NCT02530112

Studies
Functional Outcome Measures for Head and Neck Patients

NCT02530112

Sponsor

Abramson Cancer Center at Penn Medicine

Status

Terminated

Last Update Posted

Apr 11, 2025Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Otorhinolaryngology Subjects Undergoing Free Flap Surgery

Interventions

Survey

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study proved very difficult to do on paper surveys. The health system is now doing these via the chart with more success.

Expanded Access Info

Start Date

Feb 2, 2014Actual

Primary Completion Date

Dec 2024Actual

Completion Date

Dec 2024Actual

First Submitted Date

Aug 19, 2015

First Submission Date that Met QC Criteria

Aug 19, 2015

First Posted Date

Aug 20, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 9, 2025

Last Update Posted Date

Apr 11, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Survey	Other		Phase 1 Phase 2 Phase 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Completion of Survey	Completion of quality of life surveys.	9 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Steven Cannady, MD	Abramson Cancer Center at Penn Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Abramson Cancer Center of the University of Pennsylvania		Philadelphia	Pennsylvania	19104	United States

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

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Browse Branches

Not provided