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

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

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.

Study Overview

• Status: Completed
• Conditions: Oncology
• Intervention / Treatment: Other: Questionnaire

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 Type: Observational
• Enrollment (Actual): 127

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Head and neck cancer patients undergoing free-flap reconstruction

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Other: Questionnaire; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival of head and neck cancer patients with free-flap reconstruction	3 years 8 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Distant metastasis free survival of head and neck cancer patients with free-flap reconstruction	3 years 8 months

Collaborators and Investigators

• Sponsor: Taipei Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2010
• Primary Completion (Actual): June 30, 2014
• Study Completion (Actual): June 30, 2015

Study Registration Dates

• First Submitted: September 19, 2017
• First Submitted That Met QC Criteria: September 20, 2017
• First Posted (Actual): September 21, 2017

Study Record Updates

• Last Update Posted (Actual): September 21, 2017
• Last Update Submitted That Met QC Criteria: September 20, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: HKU_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No