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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


N/A
18 Years
70 Years
Open (Enrolling)
Both
Head and Neck Cancer

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Trial Information

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


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.

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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Satisfaction of care (EORTC QLQ-SAT32)

Safety Issue:

No

Principal Investigator

Philippe Maingon, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Centre de Lutte Contre le Cancer Georges-Francois Leclerc

Authority:

Unspecified

Study ID:

CDR0000683850

NCT ID:

NCT01210872

Start Date:

September 2009

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • 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
  • Head and Neck Neoplasms

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