Pretreatment Quality of Life as a Predictor of Distant Metastasis-Free Survival and Overall Survival in Patients With Head and Neck Cancer
1 other identifier
observational
127
0 countries
N/A
Brief Summary
This study shed light on an under-researched area by examining the prognostic associations of pre-treatment QoL with overall survival and distant metastasis free survival among patients with head and neck cancer who underwent free flap reconstruction. In addition, a validated instrument specific to head and neck cancer, i.e. the University of Washington Quality of Life Questionnaire (UW-QoL) was adopted.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2010
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2015
CompletedFirst Submitted
Initial submission to the registry
September 19, 2017
CompletedFirst Posted
Study publicly available on registry
September 21, 2017
CompletedSeptember 21, 2017
September 1, 2017
3.7 years
September 19, 2017
September 20, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival of head and neck cancer patients with free-flap reconstruction
3 years 8 months
Secondary Outcomes (1)
Distant metastasis free survival of head and neck cancer patients with free-flap reconstruction
3 years 8 months
Study Arms (1)
Head and neck cancer patients
Patients with oral cavity, tongue, gingival, pharyngeal, laryngeal, or salivary gland cancer and cervical lymph node metastasis who received free flap reconstruction would be enrolled in this study. However, we excluded the patients with distant metastasis identified in their medical records, and those undergoing reconstruction other than anterolateral thigh, fibular bone and radial forearm flaps.
Interventions
Patients who enrolled in the study were asked to respond to the University of Washington Quality of Life Questionnaire one week before undergoing free flap reconstruction.
Eligibility Criteria
Head and neck cancer patients undergoing free-flap reconstruction
You may qualify if:
- Patients with oral cavity, tongue, gingival, pharyngeal, laryngeal, or salivary gland cancer and cervical lymph node metastasis, and
- Received free flap reconstruction between November 2010 and June 2014 at a medical university hospital
You may not qualify if:
- Patients with distant metastasis identified in their medical records, or
- Undergoing reconstruction other than anterolateral thigh, fibular bone and radial forearm flaps
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 19, 2017
First Posted
September 21, 2017
Study Start
November 1, 2010
Primary Completion
June 30, 2014
Study Completion
June 30, 2015
Last Updated
September 21, 2017
Record last verified: 2017-09