Head and Neck CancerNCT01210872
Quality-Of-Life Assessment in Patients With Head and Neck Cancer Treated With Radiation Therapy
An observational study of Head and Neck Cancer, run by Centre Georges Francois Leclerc at 1 site in France.
Trial summary
RATIONALE: Gathering information over time about patients' quality-of-life and satisfaction with care may help doctors plan the best treatment and help patients live more comfortably. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- questionnaire administration, quality-of-life assessment and standard follow-up care
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2009to Sep 2013
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of primary nonmetastatic head and neck cancer
- No other primary cancer localizations
- No second tumor localization at the time of diagnosis
- Must be planning to be treated initially with radiotherapy
PATIENT CHARACTERISTICS:
- No cognitive impairment or psychiatric history
- No history of other cancer
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, 21079
Contact Person, 33-3-8073-7784, pmaingon@dijon.fnclcc.fr
About this study
Official title: Impact of Quality of Life Assessment in Routine Oncology Practice for Head and Neck's Cancer Patients, Treated by Radiotherapy: Impact on the Satisfaction With Care, the Health Related Quality of Life and on the Toxicity
RATIONALE: Gathering information over time about patients' quality-of-life and satisfaction with care may help doctors plan the best treatment and help patients live more comfortably.
PURPOSE: This randomized clinical trial is studying quality-of-life assessment in patients with head and neck cancer treated with radiation therapy.
Read the detailed description
OBJECTIVES:
Primary
- To evaluate the impact of quality-of-life assessment in routine oncology practice on satisfaction with care, health-related quality-of-life, and toxicity in patients with primary nonmetastatic head and neck cancer treated with radiotherapy.
Secondary
- To evaluate the feasibility of using quality-of-life tools in routine oncology practice.
- To evaluate the impact on the occurrence of toxicity.
- To determine the impact on overall survival.
- To study the concordance between the toxicity reported by the clinician and those reported by the patient quality-of-life questionnaires.
OUTLINE: Patients are stratified according to sex, tumor localization, and TNM stage. Patients are randomized to 1 of 2 arms.
- Arm I: Patients complete quality-of-life questionnaires (EORTC tools only, including EORTC QLQ-SAT32, EORTC QLQ-C30, and specific module QLQ-H\&N35/Euroqol EQ-5D) before each consultation with the clinician for one year.
- Arm II: Patients undergo standard follow-up care comprising consultation with the clinician for one year.
After completion of study, patients are followed up every 3 months for 1 year and then at 2 years.
- Conditions
- Head and Neck Cancer
- Being tested
- questionnaire administration, quality-of-life assessment, standard follow-up care
- Keywords
- stage I squamous cell carcinoma of the lip and oral cavity, stage II squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the lip and oral cavity, stage I lymphoepithelioma of the oropharynx, stage II lymphoepithelioma of the oropharynx, stage III lymphoepithelioma of the oropharynx, stage I squamous cell carcinoma of the oropharynx, stage II squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, stage I lymphoepithelioma of the nasopharynx, stage II lymphoepithelioma of the nasopharynx, stage III lymphoepithelioma of the nasopharynx, stage I squamous cell carcinoma of the nasopharynx, stage II squamous cell carcinoma of the nasopharynx, stage III squamous cell carcinoma of the nasopharynx, stage I squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the hypopharynx, stage I squamous cell carcinoma of the larynx, stage II squamous cell carcinoma of the larynx
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Tongue Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire administrationOther
quality-of-life assessmentProcedure or surgery
standard follow-up careProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction of care (EORTC QLQ-SAT32)
Quality of life (EORTC QLQ-C30 and specific module QLQ-H&N35/Euroqol EQ-5D)
Secondary outcomes (2)
Toxicity (occurrence and length) according to NCI-CTC version 3.0
Overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2010 (estimated)
- Study startSep 2009
- Primary completionSep 2013 (estimated)
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
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Investigators
- Philippe Maingon, MD, Study chair, Centre Georges Francois LeclercFranck Bonnetain, PhD, Centre Georges Francois Leclerc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01210872
- Sponsor's protocol ID
- CGFL-QDV
- Other IDs
- CDR0000683850, CGFL-AFSSAPS-2008-A01468-47, EU-21061
- Status last verified
- Sep 2010
- First submitted
- 28 Sep 2010
- Last updated
- 7 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Quality of Life Assessment in Routine Oncology Practice for Head and Neck's Cancer Patients, Treated by Radiotherapy: Impact on the Satisfaction With Care, the Health Related Quality of Life and on the Toxicity
- ClinicalTrials.gov ID
- NCT01210872
- Acronym / sponsor ID
- CGFL-QDV
- Conditions
- Head and Neck Cancer
- Keywords
- stage I squamous cell carcinoma of the lip and oral cavity, stage II squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the lip and oral cavity, stage I lymphoepithelioma of the oropharynx, stage II lymphoepithelioma of the oropharynx, stage III lymphoepithelioma of the oropharynx, stage I squamous cell carcinoma of the oropharynx, stage II squamous cell carcinoma of the oropharynx
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Sep 2013 (estimated)
- First posted
- 29 Sep 2010 (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: Gathering information over time about patients' quality-of-life and satisfaction with care may help doctors plan the best treatment and help patients live more comfortably.
PURPOSE: This randomized clinical trial is studying quality-of-life assessment in patients with head and neck cancer treated with radiation therapy.
Detailed description
OBJECTIVES:
Primary
- To evaluate the impact of quality-of-life assessment in routine oncology practice on satisfaction with care, health-related quality-of-life, and toxicity in patients with primary nonmetastatic head and neck cancer treated with radiotherapy.
Secondary
- To evaluate the feasibility of using quality-of-life tools in routine oncology practice.
- To evaluate the impact on the occurrence of toxicity.
- To determine the impact on overall survival.
- To study the concordance between the toxicity reported by the clinician and those reported by the patient quality-of-life questionnaires.
OUTLINE: Patients are stratified according to sex, tumor localization, and TNM stage. Patients are randomized to 1 of 2 arms.
- Arm I: Patients complete quality-of-life questionnaires (EORTC tools only, including EORTC QLQ-SAT32, EORTC QLQ-C30, and specific module QLQ-H\&N35/Euroqol EQ-5D) before each consultation with the clinician for one year.
- Arm II: Patients undergo standard follow-up care comprising consultation with the clinician for one year.
After completion of study, patients are followed up every 3 months for 1 year and then at 2 years.
Study design
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaire administration | Other | – |
| quality-of-life assessment | Procedure or surgery | – |
| standard follow-up care | Procedure or surgery | – |
Primary outcome
Satisfaction of care (EORTC QLQ-SAT32)
Quality of life (EORTC QLQ-C30 and specific module QLQ-H&N35/Euroqol EQ-5D)
2 secondary outcomes
Toxicity (occurrence and length) according to NCI-CTC version 3.0
Overall survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
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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.
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, France
Philippe Maingon, MD study chair
Centre Georges Francois Leclerc
Franck Bonnetain, PhD
Centre Georges Francois Leclerc
1 site 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 Centre Georges Francois Leclerc at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction of care (EORTC QLQ-SAT32). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 7 Aug 2013.