Pretreatment Quality of Life as a Predictor of Distant Metastasis-Free Survival and Overall Survival in Patients With Head and Neck Cancer

Completed

• Conditions: Oncology
• Interventions: Other: Questionnaire

• Registration Number: NCT03290352
• Lead Sponsor: Taipei Medical University

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.

Detailed Description

The importance of patient-related outcomes, especially quality of life (QoL) has been recently emphasized in the field of oncology. In conjunction with traditional biomedical indicators, QoL is recognized as a reliable parameter to reflect the health status of patients with malignancy. A growing body of evidence even points out that QoL can produce prognostic information which goes beyond biomedical indicators. In particular, since QoL may decline before any possible deterioration in health can be detected by existing biomedical measures, assessing pre-treatment QoL possibly helps identify the patients who are susceptible to a higher risk of mortality after they receive cancer treatment, which may greatly facilitate the process of clinical decision making. Despite the importance of pre-treatment QoL, its prognostic associations with overall survival and distant metastasis free survival still remain relatively under-explored.

Study Timeline

• Study Start: 2010-11-01
• Primary Completion: 2014-06-30
• Study Completion: 2015-06-30
• Status Verified: 2017-09
• Study First Submitted: 2017-09-19
• Study First Submitted QC: 2017-09-20
• Last Update Submitted: 2017-09-20
• Study First Posted: 2017-09-21
• Last Update Posted: 2017-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

Inclusion Criteria

• 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

Exclusion Criteria

• Patients with distant metastasis identified in their medical records, or
• Undergoing reconstruction other than anterolateral thigh, fibular bone and radial forearm flaps

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Head and neck cancer patients	Questionnaire	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.

Primary Outcome Measures

Name	Time	Method
Overall survival of head and neck cancer patients with free-flap reconstruction	3 years 8 months

Secondary Outcome Measures

Name	Time	Method
Distant metastasis free survival of head and neck cancer patients with free-flap reconstruction	3 years 8 months