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NCT01210872 Clinical Trial

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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01210872
Other study ID # CGFL-QDV
Secondary ID CDR0000683850CGF
Status Recruiting
Phase N/A
First received September 28, 2010
Last updated August 6, 2013
Start date September 2009

Study information
Verified date September 2010
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority Unspecified
Study type Observational

Clinical 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.

PURPOSE: This randomized clinical trial is studying quality-of-life assessment in patients with head and neck cancer treated with radiation therapy.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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 Design

N/A

Related Conditions & MeSH terms

Intervention

Other:
• questionnaire administration

Procedure:
• quality-of-life assessment

• standard follow-up care

Locations
Country Name City State
France Centre de Lutte Contre le Cancer Georges-Francois Leclerc Dijon

Sponsors (1)
Lead Sponsor Collaborator
Centre Georges Francois Leclerc

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Satisfaction of care (EORTC QLQ-SAT32) No
Primary Quality of life (EORTC QLQ-C30 and specific module QLQ-H&N35/Euroqol EQ-5D) No
Secondary Toxicity (occurrence and length) according to NCI-CTC version 3.0 Yes
Secondary Overall survival No
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