Role of the Spouse/Partner of Persons Treated With Chemotherapy for Colon Cancer
APPACH
1 other identifier
observational
12
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 4, 2016
CompletedFirst Posted
Study publicly available on registry
August 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedAugust 22, 2016
July 1, 2016
6.6 years
August 4, 2016
August 16, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Objective burden score in the dimensions of the COBQoL questionnaire with good psychometric properties
through study completion, an average of 1 year
Study Arms (2)
PATIENT
Patients with colon cancer
THE SPOUSE/PARTNER
The spouse/partner of patients with colon cancer
Interventions
Eligibility Criteria
Patients and their spouse/partner
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Dijon Bourgogne
Dijon, 21079, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2016
First Posted
August 22, 2016
Study Start
May 1, 2014
Primary Completion
December 1, 2020
Last Updated
August 22, 2016
Record last verified: 2016-07