- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01210872
Quality-Of-Life Assessment in Patients With Head and Neck Cancer Treated With Radiation Therapy
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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-
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Dijon, France, 21079
- Recruiting
- Centre de Lutte Contre le Cancer Georges-Francois Leclerc
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Contact:
- Contact Person
- Phone Number: 33-3-8073-7784
- Email: pmaingon@dijon.fnclcc.fr
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Satisfaction of care (EORTC QLQ-SAT32)
|
Quality of life (EORTC QLQ-C30 and specific module QLQ-H&N35/Euroqol EQ-5D)
|
Secondary Outcome Measures
Outcome Measure |
---|
Overall survival
|
Toxicity (occurrence and length) according to NCI-CTC version 3.0
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Philippe Maingon, MD, Centre Georges François Leclerc
- Franck Bonnetain, PhD, Centre Georges François Leclerc
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- stage III squamous cell carcinoma of the lip and oral cavity
- stage III squamous cell carcinoma of the oropharynx
- stage III lymphoepithelioma of the oropharynx
- stage III squamous cell carcinoma of the nasopharynx
- stage III lymphoepithelioma of the nasopharynx
- stage III squamous cell carcinoma of the hypopharynx
- stage III squamous cell carcinoma of the larynx
- stage III verrucous carcinoma of the larynx
- stage I squamous cell carcinoma of the lip and oral cavity
- stage II squamous cell carcinoma of the lip and oral cavity
- stage I squamous cell carcinoma of the hypopharynx
- stage I squamous cell carcinoma of the larynx
- stage I squamous cell carcinoma of the nasopharynx
- stage I squamous cell carcinoma of the oropharynx
- stage II squamous cell carcinoma of the hypopharynx
- stage II squamous cell carcinoma of the larynx
- stage II squamous cell carcinoma of the nasopharynx
- stage II squamous cell carcinoma of the oropharynx
- tongue cancer
- stage I verrucous carcinoma of the larynx
- stage II verrucous carcinoma of the larynx
- stage I lymphoepithelioma of the nasopharynx
- stage II lymphoepithelioma of the nasopharynx
- stage I lymphoepithelioma of the oropharynx
- stage II lymphoepithelioma of the oropharynx
Additional Relevant MeSH Terms
Other Study ID Numbers
- CGFL-QDV
- CDR0000683850 (Registry Identifier: PDQ (Physician Data Query))
- CGFL-AFSSAPS-2008-A01468-47
- EU-21061
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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