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

Oncology Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03290352
• Other study ID #: HKU_1
• Status: Completed
• Phase: N/A
• First received: September 19, 2017
• Last updated: September 20, 2017
• Start date: November 1, 2010
• Est. completion date: June 30, 2015

Study information

• Verified date: September 2017
• Source: Taipei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: June 30, 2015
• Est. primary completion date: June 30, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Oncology

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival of head and neck cancer patients with free-flap reconstruction		3 years 8 months
Secondary	Distant metastasis free survival of head and neck cancer patients with free-flap reconstruction		3 years 8 months