Quality of Life in Patients Treated for Head and Neck Cancer

This study has been completed.
Sponsor:
Collaborator:
University Medical Centre Groningen
Information provided by:
Maastricht Radiation Oncology
ClinicalTrials.gov Identifier:
NCT00963586
First received: August 20, 2009
Last updated: June 24, 2010
Last verified: June 2010
  Purpose

Rationale: Due to advanced technologies in the last decade, increasingly more treatment options are available for head and neck cancer (HNC). As a consequence decision-making with regard to choosing the best available treatment option is becoming increasingly relevant. Quality of life weights (utility scores) are an important outcome measure in this decision-making process. Utility scores can be combined with life expectancy, resulting in the Quality Adjusted Life Year (QALY). If in economic evaluation the outcomes are expressed in QALYs gained, it is possible to compare the efficiency of different interventions for different indications. However, limited evidence on utility scores after treatment for HNC is available.

Objective: The investigators' main objective is to examine quality of life (QoL), both utility scores and disease specific quality of life, for different treatment modalities in HNC. Secondary objectives are to examine whether QoL differs across health states, and which factors influence QoL. As extensive data are available on disease-specific quality of life, another objective is to examine whether utility scores can be derived from a commonly used disease-specific questionnaire, the EORTC QLQ-C30/QLQ-H&N35. If this would be possible, this would limit patient burden in future clinical trials. Finally, by means of measuring patients' ability to perform their work, diet and dental consequences the investigators aim to measure the impact of HNC and its treatment.

Study design: The investigators' study design is a cross-sectional survey.

Study population: The study population consists of patients with HNC who are treated at least six months ago for curative radiotherapy and/or surgery with or without chemotherapy.

Intervention/method: Patients are asked to fill out a single set of questionnaires (once-only). The set of questionnaires consists of three validated questionnaires, concerning health state utility (EuroQol-5D), disease-specific quality of life (EORTC QLQ-C30/QLQ-H&N35) and productivity losses (PRODISQ). In addition, two questions inquiring about patients' diet and three questions considering the dental status of these patients are added to the questionnaires. To classify patients into certain health states, physicians are asked to score adverse events in patients during follow-up visits (according to the RTOG classification).

Main study parameters/endpoints: The main study parameter is QoL (both disease specific quality of life and utility scores) in a certain health state. These utility scores can be used in future cost-effectiveness studies to identify the best available treatment option. Other important study parameters are the factors influencing QoL, and the relationship between utility score and disease-specific quality of life.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: As the study involves a once only set of questionnaires, the burden is only minimal. No risks are expected to be associated with participation. It is important to gain insight into QoL, patients' ability to perform their work, diet and dental consequences in long-term follow-up of HNC patients, to allow for evidence-based decision-making regarding treatment options for HNC.


Condition
Head and Neck Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Quality of Life in Patients Treated for Head and Neck Cancer

Resource links provided by NLM:


Further study details as provided by Maastricht Radiation Oncology:

Enrollment: 456
Study Start Date: June 2009
Study Completion Date: April 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
HNC Maastricht
Patients treated for HNC in the University Hospital Maastricht/MAASTRO clinic, the Netherlands
HNC Groningen
Patients treated for HNC in the University Medical Center Groningen, the Netherlands

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients treated for head and neck cancer more than 6 months ago.

Criteria

Inclusion Criteria:

  • Patients treated for HNC with curative intent
  • Finished treatment at least six months ago in the University Hospital Maastricht, MAASTRO Clinic or the University Medical Centre Groningen

Exclusion Criteria:

  • Unable to read Dutch
  • Age < 18
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00963586

Locations
Netherlands
Maastricht Radiation Oncology
Maastricht, Limburg, Netherlands
University Medical Center Groningen, Department of Radiation Oncology
Groningen, Netherlands
Sponsors and Collaborators
Maastricht Radiation Oncology
University Medical Centre Groningen
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00963586     History of Changes
Other Study ID Numbers: qol hn maastro umcg
Study First Received: August 20, 2009
Last Updated: June 24, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

ClinicalTrials.gov processed this record on July 23, 2014