Functional Outcome Measures for Head and Neck Patients

NCT02530112 | Terminated DMC

• 1 other identifier: UPCC 17913
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Otorhinolaryngology Subjects Undergoing Free Flap Surgery

Outcome Measures

Primary Outcomes (1)

• Completion of Survey

  Completion of quality of life surveys.

  9 years

Study Arms (3)

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

Survey OTHER

Phase 1; Phase 2; Phase 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Steven Cannady, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2015
• First Posted: August 20, 2015
• Study Start: February 2, 2014
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 11, 2025

Record last verified: 2023-08

Locations

US (1)