- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02873845
Role of the Spouse/Partner of Persons Treated With Chemotherapy for Colon Cancer (APPACH)
16. august 2016 opdateret af: Centre Hospitalier Universitaire Dijon
Role of the Spouse/Partner of Persons Treated With Chemotherapy for Colon Cancer - Preliminary Validation of the Caregiver Objective Burden-Quality of Life (COBQoL) Questionnaire
Altered quality of life in patients with stage III or IV colon cancer is well known.
At their sides, their spouse/partner must also cope with the suffering caused by the disease and the upheavals that it engenders, with the treatments, in the organization of their everyday life.
The physical, emotional, social and financial impact of cancer in general and its treatment on care-givers has already been studied.
However, there are no data concerning the "objective burden", that is to say the nature and the magnitude of the care weighing on the spouse of persons with colon cancer.
Objective is to develop and validate a questionnaire that can be completed by the spouse/partner of patients with stage III or IV colon cancer so as to evaluate the burden of the disease in everyday life.
It will allow medico-social professionals to identify spouses/partners in difficulty and the needs of patients so as to offer the best support.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Forventet)
12
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Dijon, Frankrig, 21079
- Rekruttering
- CHU Dijon Bourgogne
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Kontakt:
- Catherine LEJEUNE
- Telefonnummer: 03 80 39 34 88
- E-mail: catherine.lejeune@u-bourgogne.fr
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients and their spouse/partner
Beskrivelse
Inclusion Criteria:
Inclusion criteria for patients:
Men or women :
- able to understand written and spoken French ;
- Who have been informed about the study;
- with stage III or IV cancer of the colon or recto-sigmoid junction (Code C18 and C19 of the ICD 10), operated or not with curative intent; treated with chemotherapy in one of the study centres (adjuvant or 1st-line chemotherapy or palliative chemotherapy);
- Currently living with a spouse or partner;
- Who has consented to his/her spouse/partner taking part in the study.
Inclusion criteria for the spouse/partner:
Men or women:
- able to understand written and spoken French ;
- Who have been informed about the study; living at the home of the spouse/partner;
- Able to take part in an interview of approximately one hour;
- Who has provided consent to take part in the study.
Exclusion Criteria:
Exclusion criteria for patients:
Men or women :
- Under guardianship;
- With a severe disease resulting in a major handicap;
- With severe mental retardation affecting ability to understand;
- With rectal cancer;
- with stage I or II cancer of the colon or recto-sigmoid junction;
- with a history of treated cancer (colorectal or other);
- with another cancer under treatment
Exclusion criteria for the spouse:
Men or women:
- Under guardianship;
- With a severe disease resulting in a major handicap;
- With severe mental retardation affecting ability to understand
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
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PATIENT
Patients with colon cancer
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|
THE SPOUSE/PARTNER
The spouse/partner of patients with colon cancer
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Objective burden score in the dimensions of the COBQoL questionnaire with good psychometric properties
Tidsramme: through study completion, an average of 1 year
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through study completion, an average of 1 year
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. maj 2014
Primær færdiggørelse (Forventet)
1. december 2020
Datoer for studieregistrering
Først indsendt
4. august 2016
Først indsendt, der opfyldte QC-kriterier
16. august 2016
Først opslået (Skøn)
22. august 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
22. august 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. august 2016
Sidst verificeret
1. juli 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- LEJEUNE LaLigue 2014
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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