- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01210872
Quality-Of-Life Assessment in Patients With Head and Neck Cancer Treated With Radiation Therapy
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
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Dijon, Frankrig, 21079
- Rekruttering
- Centre de Lutte Contre le Cancer Georges-Francois Leclerc
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Kontakt:
- Contact Person
- Telefonnummer: 33-3-8073-7784
- E-mail: pmaingon@dijon.fnclcc.fr
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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Satisfaction of care (EORTC QLQ-SAT32)
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Quality of life (EORTC QLQ-C30 and specific module QLQ-H&N35/Euroqol EQ-5D)
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Sekundære resultatmål
Resultatmål |
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Samlet overlevelse
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Toxicity (occurrence and length) according to NCI-CTC version 3.0
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Philippe Maingon, MD, Centre Georges Francois Leclerc
- Franck Bonnetain, PhD, Centre Georges Francois Leclerc
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
- stadium III planocellulært karcinom i læben og mundhulen
- stadium III planocellulært karcinom i oropharynx
- stadium III lymfepitheliom i oropharynx
- stadium III planocellulært karcinom i nasopharynx
- stadium III lymfepitheliom i nasopharynx
- stadium III planocellulært karcinom i hypopharynx
- stadium III planocellulært karcinom i strubehovedet
- stadium III verrucous carcinom i strubehovedet
- fase I planocellulært karcinom i læben og mundhulen
- fase II planocellulært karcinom i læben og mundhulen
- stadium I planocellulært karcinom i hypopharynx
- fase I planocellulært karcinom i strubehovedet
- fase I planocellulært karcinom i nasopharynx
- stadium I planocellulært karcinom i oropharynx
- fase II planocellulært karcinom i hypopharynx
- fase II planocellulært karcinom i strubehovedet
- fase II planocellulært karcinom i nasopharynx
- fase II planocellulært karcinom i oropharynx
- tungekræft
- stadium I verrucous carcinom i strubehovedet
- stadium II verrucous carcinom i strubehovedet
- stadium I lymfepitheliom i nasopharynx
- stadium II lymfepitheliom i nasopharynx
- stadium I lymfepitheliom i oropharynx
- stadium II lymfepitheliom i oropharynx
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CGFL-QDV
- CDR0000683850 (Registry Identifier: PDQ (Physician Data Query))
- CGFL-AFSSAPS-2008-A01468-47
- EU-21061
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