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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Aging
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Actual): 391
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49055
    • ICO-Site Paul Papin
  • Arras, France, 62000
    • Centre Marie Curie
  • Avignon, France, 84918
    • Institut Sainte Catherine
  • Beuvry, France, 62660
    • Centre Pierre Curie - SCP de radiologie et d'imagerie médicale
  • Bordeaux, France, 33077
    • Polyclinique Bordeaux Nord Aquitaine
  • Boulogne-sur-Mer, France, 62321
    • CH de BOULOGNE-SUR-MER
  • Caen, France, 14036
    • Centre Francois Baclesse
  • Compiègne, France, 60200
    • Centre Hôpitalier de Compiègne Noyon
  • Dechy, France, 59187
    • Centre Leonard de Vinci
  • Dijon, France, 21079
    • Centre Georges Francois Leclerc
  • Grenoble, France, 38043
    • CHU de Grenoble
  • Le Chesnay, France, 78150
    • Centre Hospitalier André Mignot
  • Lille, France, 59020
    • Centre Oscar Lambret
  • Lille, France, 59037
    • CHRU de Lille
  • Lille, France, 59000
    • Centre Bourgogne
  • Marseille, France, 13273
    • Institut Paoli Calmettes
  • Maubeuge, France, 59603
    • Centre Gray
  • Montpellier, France, 34298
    • ICM Val d'Aurelle
  • Plérin, France, 22190
    • Hôpital privé des Côtes d'Armor
  • Poitiers, France, 86021
    • CHU
  • Pontoise, France, 95300
    • CH René Dubos
  • Reims, France, 51726
    • Institut Jean Godinot
  • Reims, France, 51100
    • ICC Reims
  • Rennes, France, 35042
    • Centre Eugène Marquis
  • Rouen, France, 76038
    • Centre Henri Becquerel
  • Saint-Cloud, France, 92210
    • Institut Curie-Hôpital Huguenin
  • Saint-Herblain, France, 44805
    • ICO - Institut Gauducheau
  • Toulouse, France, 31076
    • Unité d'Oncologie et d'hématologie ONCOSUD
  • Tours, France, 37000
    • CHU Bretonneau
  • Valenciennes, France, 59300
    • Ch Valenciennes
  • Valenciennes, France, 59300
    • Centre de cancérologie des Dentellières
  • Villeneuve-d'Ascq, France, 59657
    • Hopital Prive de Villeneuve d'Ascq

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Psychological or physical inability to fill questionnaire
• Patient under guardianship

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Study procedure; Delivery of questionnaires, Questionnaire T1 to fill, Questionnaire T2 to fill, Questionnaire T3 to fill, Questionnaire T4 to fill, Questionnaire T5 to fill

Other: Delivery of questionnaires; 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.; Behavioral: Questionnaire T1 to fill; T1 is to fill before chemotherapy.; Behavioral: Questionnaire T2 to fill; T2 is to fill after the 6th cycle of chemotherapy.; Behavioral: Questionnaire T3 to fill; T3 is to fill at the end of radiotherapy.; Behavioral: Questionnaire T4 to fill; T4 is to fill 4 month after beginning of hormonotherapy or surveillance if no hormonotherapy.; Behavioral: Questionnaire T5 to fill; T5 is to fill 1 year after the beginning of hormonotherapy or surveillance if no hormonotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
BCI-YW	To evaluate the dyadic effect's emotional skills and treatment repercussion on adjustment to cancer as well as on partner	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	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	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	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	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	an average of 1 year

Collaborators and Investigators

• Sponsor: Centre Oscar Lambret
• Collaborators: National Cancer Institute, France; Aix Marseille Université; University of Paris 5 - Rene Descartes; Canceropôle Nord Ouest; Université Lille 3; SIRIC ONCOLille
• Investigators: Principal Investigator: Laurence VANLEMMENS, MD, Oscar Lambret; Study Director: Véronique CHRISTOPHE, PhD, Université Lille 3

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2016
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: July 29, 2016
• First Submitted That Met QC Criteria: August 5, 2016
• First Posted (Estimated): August 10, 2016

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: KALICOU 3-1509; 2015-A01808-41 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO