Colon CancerAPPACHNCT02873845
Role of the Spouse/Partner of Persons Treated With Chemotherapy for Colon Cancer
An observational study of Colon Cancer, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Preliminary validation of the COBQoL questionnaire
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- May 2014to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients and their spouse/partner
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Dijon Bourgogne
Dijon, 21079
Catherine LEJEUNE, 03 80 39 34 88, catherine.lejeune@u-bourgogne.fr
About this study
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
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.
- Conditions
- Colon Cancer
- Being tested
- Preliminary validation of the COBQoL questionnaire
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preliminary validation of the COBQoL questionnaireOther
| Study group | Role | What they receive |
|---|---|---|
| PATIENT | Patients with colon cancer Receives: Other: Preliminary validation of the COBQoL questionnaire | |
| THE SPOUSE/PARTNER | The spouse/partner of patients with colon cancer Receives: Other: Preliminary validation of the COBQoL questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective burden score in the dimensions of the COBQoL questionnaire with good psychometric properties
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2016 (estimated)
- Study startMay 2014
- Primary completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02873845
- Sponsor's protocol ID
- LEJEUNE LaLigue 2014
- Acronym
- APPACH
- Status last verified
- Jul 2016
- First submitted
- 4 Aug 2016
- Last updated
- 22 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02873845
- Acronym / sponsor ID
- APPACH / LEJEUNE LaLigue 2014
- Conditions
- Colon Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2020 (estimated)
- First posted
- 22 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PATIENT | – | Other: Preliminary validation of the COBQoL questionnairePatients with colon cancer |
| THE SPOUSE/PARTNER | – | Other: Preliminary validation of the COBQoL questionnaireThe spouse/partner of patients with colon cancer |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients and their spouse/partner
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preliminary validation of the COBQoL questionnaire | Other | PATIENT, THE SPOUSE/PARTNER |
Primary outcome
Objective burden score in the dimensions of the COBQoL questionnaire with good psychometric properties
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catherine LEJEUNE (03 80 39 34 88 ext. +33, catherine.lejeune@u-bourgogne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective burden score in the dimensions of the COBQoL questionnaire with good psychometric properties (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2016.