Breast CancerKALICOU2NCT02858063
Psychometric Validation (Quality-of-life Scale) in Young Women With a Non Metastatic Breast Cancer and Her Partner
An observational study of Breast Cancer, run by Centre Oscar Lambret at 25 sites in France.
Trial summary
Selection of patient and preparation of questionnaires Presentation of the study by the doctor Verbal consent of participants (patient and Partner) Delivery of booklets Response to documents (questionnaires and written consent) at home, send by mail Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Breast Cancer
- How many people
- 1,045 participants
- Where
- 25 sitesFrance
- Study dates
- 11 Jan 2010to 27 Nov 2013
- 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
- No healthy volunteers
- Adult
Study population: Young women (<45 years old)treated or previously treated by chemotherapy for a non metastatic breast cancer, in Relationship for at least 6 months
Who may be able to join
- >18 years old (patient and partner)
- <45 years old (patient)
- Patient with a non metastatic breast cancer
- Patient treated or previously treated by chemotherapy
- Patient and her Partner live together for at least 6 months when they complete the questionnaires.
Who cannot join
- Patient or partner with psychiatric trouble
- Native language other than french
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
France25 sites
Centre Marie Curie
Arras, 62000
Centre Pierre Curie
Beuvry, 62660
Centre François Baclesse
Caen, 14076
Clinique du Parc
Croix, 59963
Centre Léonard de Vinci
Dechy, 59187
Centre d'Oncologie Dunkerquois
Dunkirk, 59240
Centre Hospitalier de Saint Omer
Helfaut, 62570
Hôpital à Mignot
Le Chesnay, 78150
Centre Bourgogne
Lille, 59000
Centre Oscar Lambret
Lille, 59020
Groupe Hospitalier de l'Institut Catholique de Lille
Lille, 59020
Collège des Gynécologues
Marcq-en-Barœul, 59700
Service du Pr FAVRE - Hôpital de la TIMONE
Marseille, 13385
Centre Gray
Maubeuge, 59600
C.H.B.M.
Montbéliard, 25200
Centre Antoine LACASSAGNE
Nice, 06189
Institut du Cancer Courlancy Reims
Reims, 51100
Centre Eugène Marquis
Rennes, 35042
Centre Henri Becquerel
Rouen, 76038
Centre René GAUDUCHEAU
Saint-Herblain, 44805
Centre Joliot Curie
Saint-Martin-Boulogne, 62280
Clinique de la Victoire
Tourcoing, 59200
Clinique des Dentellières
Valenciennes, 59300
Centre Alexis VAUTRIN
Vandœuvre-lès-Nancy, 54500
Institut Gustave Roussy
Villejuif, 94805
About this study
Official title: Psychometric Validation of a Subjective Quality-of-life Scale in Young Women With a Non Metastatic Breast Cancer and Her Partner (KALICOU 2 Protocol)
- Selection of patient and preparation of questionnaires
- Presentation of the study by the doctor
- Verbal consent of participants (patient and Partner)
- Delivery of booklets
- Response to documents (questionnaires and written consent) at home, send by mail
Read the detailed description
- Before consultation : Selection of patients according to inclusion criteria by persons in charge and preparation of inclusion file
- During the consultation :
- Presentation of the study by the investigator
- The investigator signs the information note and give two file to the patient (1 for her and 1 for her Partner : both contains 1 information note signed by the investigator, 1 questionnaire and 2 stamped envelopes
- Finally, the investigator fill-in the medical form and send the original to the university (université de Lille 3)
- At home :
- Signature of the information note and the participation consent form
- Patients and Partner responds to their questionnaire (including socio-demographic questionnaire)
- They send the documents thanks to stamped envelopes:
- They send information note to the medical center
- They send the questionnaires to the university
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Quality Of Life, Women, Partner
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pending chemotherapy +/- trastuzumab | In the 1st group (chemotherapy), 25 couples will answer to kalicou questionnaire (KALI), 25 couples to KALI plus QLQC-30 and QLQBR-23 questionnaires for patients and SF-36 questionnaire for their partners. 25 couples will answer to KALI plus STAI plus CES-D questionnaires and 25 couples will answer twice to KALI questionnaire, with a delay of 15 days between each other | |
| Pending trastuzumab +/- hormone therapy | In the 2nd group (trastuzumab), 25 couples will answer to kalicou questionnaire (KALI), 25 couples to KALI plus QLQC-30 and QLQBR-23 questionnaires for patients and SF-36 questionnaire for their partners. 25 couples will answer to KALI plus STAI plus CES-D questionnaires and 25 couples will answer twice to KALI questionnaire, with a delay of 15 days between each other | |
| Pending hormone therapy alone | In the third group (hormone therapy), 25 couples will answer to kalicou questionnaire (KALI), 25 couples to KALI plus QLQC-30 and QLQBR-23 questionnaires for patients and SF-36 questionnaire for their partners. 25 couples will answer to KALI plus STAI plus CES-D questionnaires and 25 couples will answer twice to KALI questionnaire, with a delay of 15 days between each other | |
| Pending aftercare period | In the last group (aftercare), 25 couples will answer to kalicou questionnaire (KALI), 25 couples to KALI plus QLQC-30 and QLQBR-23 questionnaires for patients and SF-36 questionnaire for their partners. 25 couples will answer to KALI plus STAI plus CES-D questionnaires and 25 couples will answer twice to KALI questionnaire, with a delay of 15 days between each other |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychometric validation of a questionnaire in Young patients and their partners
Measured: 1 year
Secondary outcomes (2)
Compare convergent and or divergent dimensions with patients and theirs partners
Measured: 1 year
Compare responses of participants according to treatment/ surveillance period
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study start11 Jan 2010
- Primary completionApr 2012
- Study completion27 Nov 2013
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
- 1,045 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Collaborators
- University Charles-de-Gaulle
- Responsible party
- Sponsor
- Investigators
- Laurence VANLEMMENS, MD, Principal investigator, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02858063
- Sponsor's protocol ID
- KALICOU2-0909
- Acronym
- KALICOU2
- Status last verified
- Mar 2026
- First submitted
- 3 Aug 2016
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Validation of a Subjective Quality-of-life Scale in Young Women With a Non Metastatic Breast Cancer and Her Partner (KALICOU 2 Protocol)
- ClinicalTrials.gov ID
- NCT02858063
- Acronym / sponsor ID
- KALICOU2 / KALICOU2-0909
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Quality Of Life, Women, Partner
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,045 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Collaborators
- University Charles-de-Gaulle
- Study start
- 11 Jan 2010 (actual)
- Primary completion
- Apr 2012 (actual)
- Study completion
- 27 Nov 2013 (actual)
- First posted
- 8 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.
- Selection of patient and preparation of questionnaires
- Presentation of the study by the doctor
- Verbal consent of participants (patient and Partner)
- Delivery of booklets
- Response to documents (questionnaires and written consent) at home, send by mail
Detailed description
- Before consultation : Selection of patients according to inclusion criteria by persons in charge and preparation of inclusion file
- During the consultation :
- Presentation of the study by the investigator
- The investigator signs the information note and give two file to the patient (1 for her and 1 for her Partner : both contains 1 information note signed by the investigator, 1 questionnaire and 2 stamped envelopes
- Finally, the investigator fill-in the medical form and send the original to the university (université de Lille 3)
- At home :
- Signature of the information note and the participation consent form
- Patients and Partner responds to their questionnaire (including socio-demographic questionnaire)
- They send the documents thanks to stamped envelopes:
- They send information note to the medical center
- They send the questionnaires to the university
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pending chemotherapy +/- trastuzumab | – | –In the 1st group (chemotherapy), 25 couples will answer to kalicou questionnaire (KALI), 25 couples to KALI plus QLQC-30 and QLQBR-23 questionnaires for patients and SF-36 questionnaire for their partners. 25 couples will answer to KALI plus STAI plus CES-D questionnaires and 25 couples will answer twice to KALI questionnaire, with a delay of 15 days between each other |
| Pending trastuzumab +/- hormone therapy | – | –In the 2nd group (trastuzumab), 25 couples will answer to kalicou questionnaire (KALI), 25 couples to KALI plus QLQC-30 and QLQBR-23 questionnaires for patients and SF-36 questionnaire for their partners. 25 couples will answer to KALI plus STAI plus CES-D questionnaires and 25 couples will answer twice to KALI questionnaire, with a delay of 15 days between each other |
| Pending hormone therapy alone | – | –In the third group (hormone therapy), 25 couples will answer to kalicou questionnaire (KALI), 25 couples to KALI plus QLQC-30 and QLQBR-23 questionnaires for patients and SF-36 questionnaire for their partners. 25 couples will answer to KALI plus STAI plus CES-D questionnaires and 25 couples will answer twice to KALI questionnaire, with a delay of 15 days between each other |
| Pending aftercare period | – | –In the last group (aftercare), 25 couples will answer to kalicou questionnaire (KALI), 25 couples to KALI plus QLQC-30 and QLQBR-23 questionnaires for patients and SF-36 questionnaire for their partners. 25 couples will answer to KALI plus STAI plus CES-D questionnaires and 25 couples will answer twice to KALI questionnaire, with a delay of 15 days between each other |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Young women (<45 years old)treated or previously treated by chemotherapy for a non metastatic breast cancer, in Relationship for at least 6 months
Key inclusion criteria (5 listed)
- >18 years old (patient and partner)
- <45 years old (patient)
- Patient with a non metastatic breast cancer
- Patient treated or previously treated by chemotherapy
- Patient and her Partner live together for at least 6 months when they complete the questionnaires.
Key exclusion criteria (2 listed)
- Patient or partner with psychiatric trouble
- Native language other than french
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Psychometric validation of a questionnaire in Young patients and their partners
Time frame: 1 year
2 secondary outcomes
Compare convergent and or divergent dimensions with patients and theirs partners
Time frame: 1 year
Compare responses of participants according to treatment/ surveillance period
Time frame: 1 year
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 16 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Laurence VANLEMMENS, MD principal investigator
Centre Oscar Lambret
25 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 25 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 5 inclusion and 2 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 16 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 25 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?
Psychometric validation of a questionnaire in Young patients and their partners (time frame: 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 16 Mar 2026.