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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01210872
First received: September 28, 2010
Last updated: August 6, 2013
Last verified: September 2010
  Purpose

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.


Condition Intervention
Head and Neck Cancer
Other: questionnaire administration
Procedure: quality-of-life assessment
Procedure: standard follow-up care

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Satisfaction of care (EORTC QLQ-SAT32) [ Designated as safety issue: No ]
  • Quality of life (EORTC QLQ-C30 and specific module QLQ-H&N35/Euroqol EQ-5D) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity (occurrence and length) according to NCI-CTC version 3.0 [ Designated as safety issue: Yes ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: September 2009
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01210872

Locations
France
Centre de Lutte Contre le Cancer Georges-Francois Leclerc Recruiting
Dijon, France, 21079
Contact: Contact Person    33-3-8073-7784    pmaingon@dijon.fnclcc.fr   
Sponsors and Collaborators
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Investigators
Study Chair: Philippe Maingon, MD Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Investigator: Franck Bonnetain, PhD Centre de Lutte Contre le Cancer Georges-Francois Leclerc
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT01210872     History of Changes
Other Study ID Numbers: CGFL-QDV, CDR0000683850, CGFL-AFSSAPS-2008-A01468-47, EU-21061
Study First Received: September 28, 2010
Last Updated: August 6, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on April 17, 2014