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

Colon Cancer Clinical Trial

— APPACH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02873845
• Other study ID #: LEJEUNE LaLigue 2014
• 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. 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

• Colon Cancer
• Colonic Neoplasms

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