Head and Neck CancerNCT00963586
Quality of Life in Patients Treated for Head and Neck Cancer
An observational study of Head and Neck Cancer, run by Maastricht Radiation Oncology at 2 sites in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- How many people
- 456 participants
- Where
- 2 sitesNetherlands
- Study dates
- Jun 2009to Apr 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated for head and neck cancer more than 6 months ago.
Who may be able to join
- 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
Who cannot join
- Unable to read Dutch
- Age < 18
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
University Medical Center Groningen, Department of Radiation Oncology
Groningen, Provincie Groningen
Maastricht Radiation Oncology
Maastricht, Limburg
About this study
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.
Read more
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.
- Conditions
- Head and Neck Cancer
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2009 (estimated)
- Study startJun 2009
- Primary completionMar 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 456 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht Radiation Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00963586
- Sponsor's protocol ID
- qol hn maastro umcg
- Status last verified
- Jun 2010
- First submitted
- 20 Aug 2009
- Last updated
- 25 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life in Patients Treated for Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT00963586
- Acronym / sponsor ID
- qol hn maastro umcg
- Conditions
- Head and Neck Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 456 participants (actual)
- Lead sponsor
- Maastricht Radiation OncologyUniversity, hospital or other
- Collaborators
- University Medical Center Groningen
- Study start
- Jun 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 21 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated for head and neck cancer more than 6 months ago.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Unable to read Dutch
- Age < 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer, run by Maastricht Radiation Oncology at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2010.