search
Back to results

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

Primary Purpose

Head and Neck Cancer

Status
Unknown status
Phase
Locations
France
Study Type
Observational
Intervention
questionnaire administration
quality-of-life assessment
standard follow-up care
Sponsored by
Centre Georges Francois Leclerc
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Head and Neck Cancer focused on measuring 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

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre de Lutte Contre le Cancer Georges-Francois LeclercRecruiting

Outcomes

Primary Outcome Measures

Satisfaction of care (EORTC QLQ-SAT32)
Quality of life (EORTC QLQ-C30 and specific module QLQ-H&N35/Euroqol EQ-5D)

Secondary Outcome Measures

Toxicity (occurrence and length) according to NCI-CTC version 3.0
Overall survival

Full Information

First Posted
September 28, 2010
Last Updated
August 6, 2013
Sponsor
Centre Georges Francois Leclerc
search

1. Study Identification

Unique Protocol Identification Number
NCT01210872
Brief Title
Quality-Of-Life Assessment in Patients With Head and Neck Cancer Treated With Radiation Therapy
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
Study Type
Observational

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Centre Georges Francois Leclerc

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, 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

7. Study Design

Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Intervention Type
Procedure
Intervention Name(s)
standard follow-up care
Primary Outcome Measure Information:
Title
Satisfaction of care (EORTC QLQ-SAT32)
Title
Quality of life (EORTC QLQ-C30 and specific module QLQ-H&N35/Euroqol EQ-5D)
Secondary Outcome Measure Information:
Title
Toxicity (occurrence and length) according to NCI-CTC version 3.0
Title
Overall survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Maingon, MD
Organizational Affiliation
Centre Georges Francois Leclerc
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Franck Bonnetain, PhD
Organizational Affiliation
Centre Georges Francois Leclerc
Facility Information:
Facility Name
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
33-3-8073-7784
Email
pmaingon@dijon.fnclcc.fr

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs