Breast CancerKALICOUNCT01661816
Breast Cancer and Quality of Life
An observational study of Breast Cancer, run by Centre Oscar Lambret at 4 sites in France.
Trial summary
The study aims to analyse and decode interviews of patient with breast cancer, and then established according a multidimensional profile specific to the population and to create a questionnaire tha will allow a practical and qualitative evaluation of the quality of life. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- interview
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 171 participants
- Where
- 4 sitesFrance
- Study dates
- Apr 2007to Jun 2008
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: patient with breast cancer, diagnosed before aged 45, having a life partner
Who may be able to join
- age < 45
- non metastatic breast cancer
- at least 6 months of relationship
Who cannot join
- no life partner
Trial locations and contacts
4 sites in 1 country.
France4 sites
François Baclesse Center
Caen
Oscar Lambret Center
Lille, 59 020
Gustave Roussy Institut
Paris, 75 005
Hospital
Valenciennes
About this study
Official title: Impact of Breast Cancer on Quality of Life of the Young Women, Her Life Partner and Her Couple
The study aims to analyse and decode interviews of patient with breast cancer, and then established according a multidimensional profile specific to the population and to create a questionnaire tha will allow a practical and qualitative evaluation of the quality of life.
- Conditions
- Breast Cancer
- Being tested
- interview
- Keywords
- breast cancer, everyday issues, couple
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interviewBehavioural
psychological, emotional, family and social parameters
| Study group | Role | What they receive |
|---|---|---|
| Within chemotherapy | 30 couples, interviewed within chemotherapy (6 to 8 months after diagnosis) Receives: Behavioral: interview | |
| within Herceptin | 30 couples, within herceptin treatment (the first year after diagnosis) Receives: Behavioral: interview | |
| within hormonotherapy | 30 couples, within hormonotherapy (between 2 and 7 years after diagnosis) Receives: Behavioral: interview | |
| without hormonotherapy | 30 couples, did not received hormonotherapy (1 year after diagnosis) Receives: Behavioral: interview | |
| end of treatment | 30 couples, after end of treatments for patients who did received hormonotherapy (7 years after diagnosis) Receives: Behavioral: interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life at different time of medical follow up
interviews with couples at different time frame depending on which group they are in
Measured: 6 months after diagnosis, 1 year after diagnosis, between 2 and 7 years after diagnosis, 7 years past diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2012 (estimated)
- Study startApr 2007
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01661816
- Sponsor's protocol ID
- KALICOU-0702
- Acronym
- KALICOU
- Status last verified
- Mar 2026
- First submitted
- 2 Aug 2012
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Breast Cancer on Quality of Life of the Young Women, Her Life Partner and Her Couple
- ClinicalTrials.gov ID
- NCT01661816
- Acronym / sponsor ID
- KALICOU / KALICOU-0702
- Conditions
- Breast Cancer
- Keywords
- breast cancer, everyday issues, couple
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- Apr 2007 (actual)
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 10 Aug 2012 (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.
The study aims to analyse and decode interviews of patient with breast cancer, and then established according a multidimensional profile specific to the population and to create a questionnaire tha will allow a practical and qualitative evaluation of the quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Within chemotherapy | – | Behavioral: interview30 couples, interviewed within chemotherapy (6 to 8 months after diagnosis) |
| within Herceptin | – | Behavioral: interview30 couples, within herceptin treatment (the first year after diagnosis) |
| within hormonotherapy | – | Behavioral: interview30 couples, within hormonotherapy (between 2 and 7 years after diagnosis) |
| without hormonotherapy | – | Behavioral: interview30 couples, did not received hormonotherapy (1 year after diagnosis) |
| end of treatment | – | Behavioral: interview30 couples, after end of treatments for patients who did received hormonotherapy (7 years after diagnosis) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- patient with breast cancer, diagnosed before aged 45, having a life partner
Key inclusion criteria (3 listed)
- age < 45
- non metastatic breast cancer
- at least 6 months of relationship
Key exclusion criteria (1 listed)
- no life partner
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 |
|---|---|---|
| interviewpsychological, emotional, family and social parameters | Behavioural | Within chemotherapy, end of treatment, within Herceptin, within hormonotherapy, without hormonotherapy |
Primary outcome
quality of life at different time of medical follow up
Time frame: 6 months after diagnosis, 1 year after diagnosis, between 2 and 7 years after diagnosis, 7 years past diagnosis
interviews with couples at different time frame depending on which group they are in
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Centre Oscar Lambret at 4 sites 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of life at different time of medical follow up (time frame: 6 months after diagnosis, 1 year after diagnosis, between 2 and 7 years after diagnosis, 7 years past diagnosis). 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 13 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.