Head and Neck Cancer Clinical Trial
Official title:
Quality of Life in Patients Treated for Head and Neck Cancer
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.
Status | Completed |
Enrollment | 456 |
Est. completion date | April 2010 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
Netherlands | University Medical Center Groningen, Department of Radiation Oncology | Groningen | |
Netherlands | Maastricht Radiation Oncology | Maastricht | Limburg |
Lead Sponsor | Collaborator |
---|---|
Maastricht Radiation Oncology | University Medical Center Groningen |
Netherlands,
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