AgingKALICOU3NCT02861742
Impact of Emotional Skills of Young Women and Their Partner on Adjustment to Cancer
A study testing Delivery of questionnaires, Questionnaire T1 to fill and Questionnaire T2 to fill in people with Aging and Breast Cancer, run by Centre Oscar Lambret at 32 sites in France.
Trial summary
The KALICOU 3 study will evaluate the effect of emotional skills of patients and their partners on their individual disease subjective experience during care pathways, from chemotherapy to surveillance. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Aging, Breast Cancer
- What is being tested?
- Delivery of questionnaires, Questionnaire T1 to fill and Questionnaire T2 to fill
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 391 participants
- Where
- 32 sitesFrance
- Study dates
- 25 Jul 2016to Jan 2022
- Phase
- Interventional
- 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
Who may be able to join
- Patient and partner ≥ 18 years.
- Patient ≤ 45 years at diagnostic of non metastatic breast cancer.
- Disease relevant for neoadjuvant or adjuvant chemotherapy following or not by radiotherapy or hormonotherapy.
- Heterosexual or homosexual couples in a relationship since at least 6 months at the date of inclusion
- Patient affiliate to french social welfare system
- Informed consent sign by patient and partner before any study procedure
Who cannot join
- Psychological or physical inability to fill questionnaire
- Patient under guardianship
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
France32 sites
ICO-Site Paul Papin
Angers, 49055
Centre Marie Curie
Arras, 62000
Institut Sainte Catherine
Avignon, 84918
Centre Pierre Curie - SCP de radiologie et d'imagerie médicale
Beuvry, 62660
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33077
CH de BOULOGNE-SUR-MER
Boulogne-sur-Mer, 62321
Centre François Baclesse
Caen, 14036
Centre Hôpitalier de Compiègne Noyon
Compiègne, 60200
Centre Léonard de Vinci
Dechy, 59187
Centre Georges François Leclerc
Dijon, 21079
CHU de Grenoble
Grenoble, 38043
Centre Hospitalier André Mignot
Le Chesnay, 78150
Centre Bourgogne
Lille, 59000
Centre Oscar Lambret
Lille, 59020
CHRU de Lille
Lille, 59037
Institut Paoli Calmettes
Marseille, 13273
Centre Gray
Maubeuge, 59603
ICM Val d'Aurelle
Montpellier, 34298
Hôpital Privé des Côtes d'Armor
Plérin, 22190
CHU
Poitiers, 86021
CH René Dubos
Pontoise, 95300
ICC Reims
Reims, 51100
Institut Jean Godinot
Reims, 51726
Centre Eugène Marquis
Rennes, 35042
Centre Henri Becquerel
Rouen, 76038
Institut Curie-Hôpital Huguenin
Saint-Cloud, 92210
ICO - Institut Gauducheau
Saint-Herblain, 44805
Unité d'Oncologie et d'hématologie ONCOSUD
Toulouse, 31076
CHU Bretonneau
Tours, 37000
Centre de Cancérologie des Dentellières
Valenciennes, 59300
CH Valenciennes
Valenciennes, 59300
Hôpital Privé de Villeneuve d'Ascq
Villeneuve-d'Ascq, 59657
About this study
Official title: Evaluation of the Impact of Emotional Skills of Young Women (≤ 45 Years), With Non-metastatic Breast Cancer, and Their Partner on Adjustment to Cancer
The KALICOU 3 study will evaluate the effect of emotional skills of patients and their partners on their individual disease subjective experience during care pathways, from chemotherapy to surveillance.
Read the detailed description
All women with breast cancer have to face, at any age, to numerous issues linked to cancer (incertitude, recurrence anxiety...) and to physical and psychosocial side effects of treatments which can degrade their life quality. However, young women (<45 years at diagnostic) have to face specific issues related to their age (early menopause, withdrawal of pregnancy projects, education of young children). Moreover, treatment consequences can alter patient's life quality and can persist in time (fatigue, pains, chemotherapy, sexuality, induced menopause for example). Overall, young patients have a lesser life quality, greater emotional distress and vulnerability and have more difficulties to establish adapted adjustment strategy compared to elder women.
The role and importance of relatives, particularly partners, during cancer pathology is incontestable. However, few empiric and consensual data exist on the impact of cancer diagnostic on partners, especially when women are young at initial diagnostic. Nevertheless, available data underline the importance of the supporting partner during breast cancer disease.
Cancer also disturbs conjugal relationship. For example, life quality of patient influence strongly the life quality and mental well-being of her partner. Moreover, the intimate relation with the partner could play an important role in healing after breast cancer. Numerous authors underline the importance of focus on the couple instead of patients alone or partners alone with a dyadic approach where dyad member's reactions will be interdependent.
Thus, study of dyadic adjustment of couples where a member is facing cancer pathology at young age is indubitably innovative and present a real scientific and clinical interest. More precisely, KALICOU 3 study will focus on the impact of intrapersonal and interpersonal emotional skills of patients and partners on individual and dyadic adjustment.
- Conditions
- Aging, Breast Cancer
- Being tested
- Delivery of questionnaires, Questionnaire T1 to fill, Questionnaire T2 to fill, Questionnaire T3 to fill, Questionnaire T4 to fill
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delivery of questionnairesOther
After patient and partner information, clinical research associate or clinical research nurse will give to the couple 2 booklets containing 5 questionnaires, respectively T1, T2, T3, T4 and T5.
Questionnaire T1 to fillBehavioural
T1 is to fill before chemotherapy.
Questionnaire T2 to fillBehavioural
T2 is to fill after the 6th cycle of chemotherapy.
Questionnaire T3 to fillBehavioural
T3 is to fill at the end of radiotherapy.
Questionnaire T4 to fillBehavioural
T4 is to fill 4 month after beginning of hormonotherapy or surveillance if no hormonotherapy.
Questionnaire T5 to fillBehavioural
T5 is to fill 1 year after the beginning of hormonotherapy or surveillance if no hormonotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Study procedure | Other | Delivery of questionnaires, Questionnaire T1 to fill, Questionnaire T2 to fill, Questionnaire T3 to fill, Questionnaire T4 to fill, Questionnaire T5 to fill Receives: Other: Delivery of questionnaires; Behavioral: Questionnaire T1 to fill; Behavioral: Questionnaire T2 to fill; Behavioral: Questionnaire T3 to fill; Behavioral: Questionnaire T4 to fill; Behavioral: Questionnaire T5 to fill |
What is being measured
The primary outcome is the main question the study is designed to answer.
BCI-YW ( Breast Cancer Inventory - Young Women)
To evaluate the effect of emotional skills of patients and partners on their individual disease subjective experience during care pathways, from chemotherapy to surveillance
Measured: an average of 1 year
BCI-Partner's YW ( Breast Cancer Inventory - Young Women Partner's)
To evaluate the effect of emotional skills of patients and partners on their individual disease subjective experience during care pathways, from chemotherapy to surveillance
Measured: an average of 1 year
PEC (Profile of Emotional Competences)
To evaluate the effect of emotional skills of patients and partners on their individual disease subjective experience during care pathways, from chemotherapy to surveillance
Measured: an average of 1 year
Secondary outcomes (6)
BCI-YW
To evaluate the dyadic effect's emotional skills and treatment repercussion on adjustment to cancer as well as on partner
Measured: an average of 1 year
BCI-Partner's YW
To evaluate the dyadic effect's emotional skills and treatment repercussion on adjustment to cancer as well as on partner
Measured: an average of 1 year
SF 36 (Short Form 36 - Health Survey)
To evaluate the dyadic effect's emotional skills and treatment repercussion on adjustment to cancer as well as on partner
Measured: an average of 1 year
Hospital Anxiety-Depression Scale
To evaluate the dyadic effect's emotional skills and treatment repercussion on adjustment to cancer as well as on partner
Measured: an average of 1 year
Profile of Emotional Competences
To evaluate the dyadic effect's emotional skills on adjustment to cancer as well as on partner
Measured: an average of 1 year
MAVA (Measure of affectivity: Valence/Activation)
To evaluate the dyadic effect's emotional skills on adjustment to cancer as well as on partner
Measured: 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 posted10 Aug 2016 (estimated)
- Study start25 Jul 2016
- Primary completionJun 2021
- Study completionJan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 391 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Collaborators
- University Charles-de-Gaulle, Aix Marseille Université, University of Paris 5 - Rene Descartes, SIRIC ONCOLille, Canceropôle Nord Ouest, National Cancer Institute, France
- Responsible party
- Sponsor
- Investigators
- Laurence VANLEMMENS, MD, Principal investigator, Oscar LambretVéronique CHRISTOPHE, PhD, Study director, University Charles-de-Gaulle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02861742
- Sponsor's protocol ID
- KALICOU 3-1509
- Other IDs
- 2015-A01808-41
- Acronym
- KALICOU3
- Status last verified
- Mar 2026
- First submitted
- 29 Jul 2016
- Last updated
- 18 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 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Emotional Skills of Young Women (≤ 45 Years), With Non-metastatic Breast Cancer, and Their Partner on Adjustment to Cancer
- ClinicalTrials.gov ID
- NCT02861742
- Acronym / sponsor ID
- KALICOU3 / KALICOU 3-1509
- Conditions
- Aging, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 391 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Collaborators
- University Charles-de-Gaulle, Aix Marseille Université, University of Paris 5 - Rene Descartes, SIRIC ONCOLille, Canceropôle Nord Ouest, National Cancer Institute, France
- Study start
- 25 Jul 2016 (actual)
- Primary completion
- Jun 2021 (actual)
- Study completion
- Jan 2022 (actual)
- First posted
- 10 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.
The KALICOU 3 study will evaluate the effect of emotional skills of patients and their partners on their individual disease subjective experience during care pathways, from chemotherapy to surveillance.
Detailed description
All women with breast cancer have to face, at any age, to numerous issues linked to cancer (incertitude, recurrence anxiety...) and to physical and psychosocial side effects of treatments which can degrade their life quality. However, young women (<45 years at diagnostic) have to face specific issues related to their age (early menopause, withdrawal of pregnancy projects, education of young children). Moreover, treatment consequences can alter patient's life quality and can persist in time (fatigue, pains, chemotherapy, sexuality, induced menopause for example). Overall, young patients have a lesser life quality, greater emotional distress and vulnerability and have more difficulties to establish adapted adjustment strategy compared to elder women.
The role and importance of relatives, particularly partners, during cancer pathology is incontestable. However, few empiric and consensual data exist on the impact of cancer diagnostic on partners, especially when women are young at initial diagnostic. Nevertheless, available data underline the importance of the supporting partner during breast cancer disease.
Cancer also disturbs conjugal relationship. For example, life quality of patient influence strongly the life quality and mental well-being of her partner. Moreover, the intimate relation with the partner could play an important role in healing after breast cancer. Numerous authors underline the importance of focus on the couple instead of patients alone or partners alone with a dyadic approach where dyad member's reactions will be interdependent.
Thus, study of dyadic adjustment of couples where a member is facing cancer pathology at young age is indubitably innovative and present a real scientific and clinical interest. More precisely, KALICOU 3 study will focus on the impact of intrapersonal and interpersonal emotional skills of patients and partners on individual and dyadic adjustment.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study procedure | Other | Other: Delivery of questionnaires, Behavioral: Questionnaire T1 to fill, Behavioral: Questionnaire T2 to fill, Behavioral: Questionnaire T3 to fill, Behavioral: Questionnaire T4 to fill, Behavioral: Questionnaire T5 to fillDelivery of questionnaires, Questionnaire T1 to fill, Questionnaire T2 to fill, Questionnaire T3 to fill, Questionnaire T4 to fill, Questionnaire T5 to fill |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patient and partner ≥ 18 years.
- Patient ≤ 45 years at diagnostic of non metastatic breast cancer.
- Disease relevant for neoadjuvant or adjuvant chemotherapy following or not by radiotherapy or hormonotherapy.
- Heterosexual or homosexual couples in a relationship since at least 6 months at the date of inclusion
- Patient affiliate to french social welfare system
Key exclusion criteria (2 listed)
- Psychological or physical inability to fill questionnaire
- Patient under guardianship
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 |
|---|---|---|
| Delivery of questionnairesAfter patient and partner information, clinical research associate or clinical research nurse will give to the couple 2 booklets containing 5 questionnaires, respectively T1, T2, T3, T4 and T5. | Other | Study procedure |
| Questionnaire T1 to fillT1 is to fill before chemotherapy. | Behavioural | Study procedure |
| Questionnaire T2 to fillT2 is to fill after the 6th cycle of chemotherapy. | Behavioural | Study procedure |
| Questionnaire T3 to fillT3 is to fill at the end of radiotherapy. | Behavioural | Study procedure |
| Questionnaire T4 to fillT4 is to fill 4 month after beginning of hormonotherapy or surveillance if no hormonotherapy. | Behavioural | Study procedure |
| Questionnaire T5 to fillT5 is to fill 1 year after the beginning of hormonotherapy or surveillance if no hormonotherapy. | Behavioural | Study procedure |
Primary outcome
BCI-YW ( Breast Cancer Inventory - Young Women)
Time frame: an average of 1 year
To evaluate the effect of emotional skills of patients and partners on their individual disease subjective experience during care pathways, from chemotherapy to surveillance
BCI-Partner's YW ( Breast Cancer Inventory - Young Women Partner's)
Time frame: an average of 1 year
To evaluate the effect of emotional skills of patients and partners on their individual disease subjective experience during care pathways, from chemotherapy to surveillance
PEC (Profile of Emotional Competences)
Time frame: an average of 1 year
To evaluate the effect of emotional skills of patients and partners on their individual disease subjective experience during care pathways, from chemotherapy to surveillance
6 secondary outcomes
BCI-YW
Time frame: an average of 1 year
BCI-Partner's YW
Time frame: an average of 1 year
SF 36 (Short Form 36 - Health Survey)
Time frame: an average of 1 year
Hospital Anxiety-Depression Scale
Time frame: an average of 1 year
Profile of Emotional Competences
Time frame: an average of 1 year
MAVA (Measure of affectivity: Valence/Activation)
Time frame: an average of 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 18 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Aging
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
Not yet recruitingPhase 2
Validation & Intervention Testing for Aging, Longevity and Healthspan
Aging, Functional Decline
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
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
Oscar Lambret
Véronique CHRISTOPHE, PhD study director
University Charles-de-Gaulle
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delivery of questionnaires, Questionnaire T1 to fill and Questionnaire T2 to fill in people with Aging and Breast Cancer, run by Centre Oscar Lambret at 32 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 6 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 18 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 32 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?
BCI-YW ( Breast Cancer Inventory - Young Women) (time frame: an average of 1 year). The study lists 3 primary outcomes in all. 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 18 Mar 2026.