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CompletedNCT03290352Updated Sep 21, 2017

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

An observational study in Oncology, sponsored by Taipei Medical University. Completed. Per ClinicalTrials.gov, last updated 2017-09-21.

Sponsored by Taipei Medical University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
127
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Oncology
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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Head and neck cancer patients undergoing free-flap reconstruction

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
127 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • OtherQuestionnaire

    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.

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What researchers measure

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

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03290352
Lead sponsor
Taipei Medical University
Responsible party
Chia-Chin Lin (Professor, Taipei Medical University) — Principal investigator
First posted
Sep 21, 2017
Start date
Nov 1, 2010
Primary completion
Jun 30, 2014
Completion
Jun 30, 2015
Last update
Sep 21, 2017

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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