ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03290352
Recruitment Status : Completed
First Posted : September 21, 2017
Last Update Posted : September 21, 2017
Sponsor:
Information provided by (Responsible Party):
Chia-Chin Lin, Taipei Medical University

Brief 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.

Condition or disease Intervention/treatment
Oncology 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
Actual Enrollment : 127 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Overall survival of head and neck cancer patients with free-flap reconstruction [ Time Frame: 3 years 8 months ]

Secondary Outcome Measures :
  1. Distant metastasis free survival of head and neck cancer patients with free-flap reconstruction [ Time Frame: 3 years 8 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Head and neck cancer patients undergoing free-flap reconstruction
Criteria

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

Responsible Party: Chia-Chin Lin, Professor, Taipei Medical University
ClinicalTrials.gov Identifier: NCT03290352     History of Changes
Other Study ID Numbers: HKU_1
First Posted: September 21, 2017    Key Record Dates
Last Update Posted: September 21, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms