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Completed

NCT Number: NCT03290352

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

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.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Other

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 outcomes

  1. Overall survival of head and neck cancer patients with free-flap reconstruction

    Time frame: 3 years 8 months

Secondary outcomes

  1. Distant metastasis free survival of head and neck cancer patients with free-flap reconstruction

    Time frame: 3 years 8 months

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
Sep 21, 2017
Registry last updated
Sep 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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