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

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ClinicalTrials.gov Identifier: NCT02873845
Recruitment Status : Recruiting
First Posted : August 22, 2016
Last Update Posted : August 22, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

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.

Condition or disease Intervention/treatment
Colon Cancer Other: Preliminary validation of the COBQoL questionnaire

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Study Type : Observational
Estimated Enrollment : 12 participants
Time Perspective: Prospective
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
Study Start Date : May 2014
Estimated Primary Completion Date : December 2020

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



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


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients and their spouse/partner
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02873845


Contacts
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Contact: Catherine LEJEUNE 03 80 39 34 88 ext +33 catherine.lejeune@u‐bourgogne.fr

Locations
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France
CHU Dijon Bourgogne Recruiting
Dijon, France, 21079
Contact: Catherine LEJEUNE    03 80 39 34 88    catherine.lejeune@u‐bourgogne.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT02873845     History of Changes
Other Study ID Numbers: LEJEUNE LaLigue 2014
First Posted: August 22, 2016    Key Record Dates
Last Update Posted: August 22, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases