Pretreatment Quality of Life as a Predictor of Distant Metastasis-Free Survival and Overall Survival in Patients With Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT03290352|
Recruitment Status : Completed
First Posted : September 21, 2017
Last Update Posted : September 21, 2017
Taipei Medical University
Information provided by (Responsible Party):
Chia-Chin Lin, Taipei Medical University
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.
|Condition or disease||Intervention/treatment|
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|
|Actual Enrollment :||127 participants|
|Official Title:||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|
|Actual Study Start Date :||November 1, 2010|
|Actual Primary Completion Date :||June 30, 2014|
|Actual Study Completion Date :||June 30, 2015|
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.
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.
Primary Outcome Measures :
- Overall survival of head and neck cancer patients with free-flap reconstruction [ Time Frame: 3 years 8 months ]
Secondary Outcome Measures :
- Distant metastasis free survival of head and neck cancer patients with free-flap reconstruction [ Time Frame: 3 years 8 months ]
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