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

August 16, 2016 updated by: 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients and their spouse/partner

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PATIENT
Patients with colon cancer
Other: Preliminary validation of the COBQoL questionnaire
THE SPOUSE/PARTNER
The spouse/partner of patients with colon cancer
Other: Preliminary validation of the COBQoL questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective burden score in the dimensions of the COBQoL questionnaire with good psychometric properties
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

August 4, 2016

First Submitted That Met QC Criteria

August 16, 2016

First Posted (Estimate)

August 22, 2016

Study Record Updates

Last Update Posted (Estimate)

August 22, 2016

Last Update Submitted That Met QC Criteria

August 16, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LEJEUNE LaLigue 2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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