Impact of Emotional Skills of Young Women and Their Partner on Adjustment to Cancer
KALICOU3
Evaluation of the Impact of Emotional Skills of Young Women (≤ 45 Years), With Non-metastatic Breast Cancer, and Their Partner on Adjustment to Cancer
2 other identifiers
interventional
391
1 country
32
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2016
Longer than P75 for not_applicable
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 25, 2016
CompletedFirst Submitted
Initial submission to the registry
July 29, 2016
CompletedFirst Posted
Study publicly available on registry
August 10, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2022
CompletedMarch 18, 2026
March 1, 2026
4.9 years
July 29, 2016
March 16, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
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
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
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
an average of 1 year
Secondary Outcomes (6)
BCI-YW
an average of 1 year
BCI-Partner's YW
an average of 1 year
SF 36 (Short Form 36 - Health Survey)
an average of 1 year
Hospital Anxiety-Depression Scale
an average of 1 year
Profile of Emotional Competences
an average of 1 year
- +1 more secondary outcomes
Study Arms (1)
Study procedure
OTHERDelivery of questionnaires, Questionnaire T1 to fill, Questionnaire T2 to fill, Questionnaire T3 to fill, Questionnaire T4 to fill, Questionnaire T5 to fill
Interventions
T4 is to fill 4 month after beginning of hormonotherapy or surveillance if no hormonotherapy.
T5 is to fill 1 year after the beginning of hormonotherapy or surveillance if no hormonotherapy.
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.
Eligibility Criteria
You may qualify if:
- 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.
- Patient affiliate to french social welfare system
- Informed consent sign by patient and partner before any study procedure
You may not qualify if:
- Psychological or physical inability to fill questionnaire
- Patient under guardianship
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Oscar Lambretlead
- Université Lille 3collaborator
- Aix Marseille Universitécollaborator
- University of Paris 5 - Rene Descartescollaborator
- SIRIC ONCOLillecollaborator
- Canceropôle Nord Ouestcollaborator
- National Cancer Institute, Francecollaborator
Study Sites (32)
ICO-Site Paul Papin
Angers, 49055, France
Centre Marie Curie
Arras, 62000, France
Institut Sainte Catherine
Avignon, 84918, France
Centre Pierre Curie - SCP de radiologie et d'imagerie médicale
Beuvry, 62660, France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33077, France
CH de BOULOGNE-SUR-MER
Boulogne-sur-Mer, 62321, France
Centre François Baclesse
Caen, 14036, France
Centre Hôpitalier de Compiègne Noyon
Compiègne, 60200, France
Centre Léonard de Vinci
Dechy, 59187, France
Centre Georges François Leclerc
Dijon, 21079, France
CHU de Grenoble
Grenoble, 38043, France
Centre Hospitalier André Mignot
Le Chesnay, 78150, France
Centre Bourgogne
Lille, 59000, France
Centre Oscar Lambret
Lille, 59020, France
CHRU de Lille
Lille, 59037, France
Institut Paoli Calmettes
Marseille, 13273, France
Centre Gray
Maubeuge, 59603, France
ICM Val d'Aurelle
Montpellier, 34298, France
Hôpital Privé des Côtes d'Armor
Plérin, 22190, France
CHU
Poitiers, 86021, France
CH René Dubos
Pontoise, 95300, France
ICC Reims
Reims, 51100, France
Institut Jean Godinot
Reims, 51726, France
Centre Eugène Marquis
Rennes, 35042, France
Centre Henri Becquerel
Rouen, 76038, France
Institut Curie-Hôpital Huguenin
Saint-Cloud, 92210, France
ICO - Institut Gauducheau
Saint-Herblain, 44805, France
Unité d'Oncologie et d'hématologie ONCOSUD
Toulouse, 31076, France
CHU Bretonneau
Tours, 37000, France
Centre de Cancérologie des Dentellières
Valenciennes, 59300, France
CH Valenciennes
Valenciennes, 59300, France
Hôpital Privé de Villeneuve d'Ascq
Villeneuve-d'Ascq, 59657, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laurence VANLEMMENS, MD
Oscar Lambret
- STUDY DIRECTOR
Véronique CHRISTOPHE, PhD
Université Lille 3
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2016
First Posted
August 10, 2016
Study Start
July 25, 2016
Primary Completion
June 1, 2021
Study Completion
January 1, 2022
Last Updated
March 18, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share