MedDataX Logo

Quality-Of-Life Assessment in Patients With Head and Neck Cancer Treated With Radiation Therapy

NCT ID: NCT01210872

Last Updated: 2013-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Head and Neck Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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 stage III squamous cell carcinoma of the larynx stage I verrucous carcinoma of the larynx stage II verrucous carcinoma of the larynx stage III verrucous carcinoma of the larynx tongue cancer

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

questionnaire administration

Intervention Type OTHER

quality-of-life assessment

Intervention Type PROCEDURE

standard follow-up care

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Georges Francois Leclerc

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Philippe Maingon, MD

Role: STUDY_CHAIR

Centre Georges Francois Leclerc

Franck Bonnetain, PhD

Role:

Centre Georges Francois Leclerc

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre de Lutte Contre le Cancer Georges-Francois Leclerc

Dijon, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Contact Person

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CDR0000683850

Identifier Type: REGISTRY

Identifier Source: secondary_id

CGFL-AFSSAPS-2008-A01468-47

Identifier Type: -

Identifier Source: secondary_id

EU-21061

Identifier Type: -

Identifier Source: secondary_id

CGFL-QDV

Identifier Type: -

Identifier Source: org_study_id