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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02873845
Other study ID # LEJEUNE LaLigue 2014
Secondary ID
Status Recruiting
Phase N/A
First received August 4, 2016
Last updated August 16, 2016
Start date May 2014

Study information

Verified date July 2016
Source Centre Hospitalier Universitaire Dijon
Contact Catherine LEJEUNE
Phone 03 80 39 34 88
Email catherine.lejeune@u-bourgogne.fr
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 12
Est. completion date
Est. primary completion date December 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
Preliminary validation of the COBQoL questionnaire


Locations

Country Name City State
France CHU Dijon Bourgogne Dijon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective burden score in the dimensions of the COBQoL questionnaire with good psychometric properties through study completion, an average of 1 year Yes
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