Functional Outcome Measures for Head and Neck Patients

Abramson Cancer Center at Penn Medicine

Status: Terminated

Conditions: Otorhinolaryngology Subjects Undergoing Free Flap Surgery

Treatments: Other: Survey

Study type: Observational

Funder types: Other

Identifiers

NCT02530112

UPCC 17913

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,000 participants in 3 patient groups

Phase 1

Description:

First round of survey respondents.

Treatment:

Other: Survey

Phase 2

Description:

Second round of survey respondents.

Treatment:

Other: Survey

Phase 3

Description:

Third round of survey respondents.

Treatment:

Other: Survey