NCT06756763

Brief Summary

This study examines the quality of life for patients after head and neck free flap reconstruction, both pre-operative and at least 1 year post-operative. It aims to find out what influences quality of life, and whether these changes are stable over time. It will use a new method of analysis called "Time to Deterioration" which tells us when a patient notices a significant change in their quality of life, when subsequently does not get better.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
315

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 27, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 3, 2025

Completed
Last Updated

January 3, 2025

Status Verified

December 1, 2024

Enrollment Period

8.5 years

First QC Date

December 27, 2024

Last Update Submit

December 27, 2024

Conditions

Head and Neck CancerFree Flap

Keywords

Quality of lifeLongitudinalSurvival

Outcome Measures

Primary Outcomes (1)

  • University of Wisconsin Quality of Life Questionnaire

    University of Winconsin Quality of Life (UW-QoL) questionnaire (Taiwan mandarin version v4) is a 12-item scale with additional global questions, scored from 0 to 100, with separate Physical and Social component scores providing a composite overall score. Higher scores indicate higher quality of life.

    Once at enrollment pre-operatively, and repeated at least 1 year post-operatively

Study Arms (1)

Head and Neck Reconstruction patients

Head and Neck Reconstruction patients undergoing free flap reconstruction

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Head and neck disease both benign and maligant

You may qualify if:

  • free flap reconstruction
  • benign or malignant head and neck disease

You may not qualify if:

  • did not undergo free flap reconstruction
  • extra-oral disease eg scalp
  • patients unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Linkou District, Taiwan

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Design

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

Study Record Dates

First Submitted

December 27, 2024

First Posted

January 3, 2025

Study Start

March 1, 2015

Primary Completion

September 1, 2023

Study Completion

December 26, 2024

Last Updated

January 3, 2025

Record last verified: 2024-12

Locations

TW(1)