Role of the Spouse/Partner of Persons Treated With Chemotherapy for Colon Cancer

NCT ID: NCT02873845

Last Updated: 2016-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Colon Cancer

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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PATIENT

Patients with colon cancer

Preliminary validation of the COBQoL questionnaire

Intervention Type OTHER

THE SPOUSE/PARTNER

The spouse/partner of patients with colon cancer

Preliminary validation of the COBQoL questionnaire

Intervention Type OTHER

Interventions

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Preliminary validation of the COBQoL questionnaire

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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.


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

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


Men or women:

* Under guardianship;
* With a severe disease resulting in a major handicap;
* With severe mental retardation affecting ability to understand
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Dijon Bourgogne

Dijon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Catherine LEJEUNE

Role: CONTACT

03 80 39 34 88 ext. +33

Facility Contacts

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Catherine LEJEUNE

Role: primary

03 80 39 34 88

Other Identifiers

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LEJEUNE LaLigue 2014

Identifier Type: -

Identifier Source: org_study_id

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