Impact of Emotional Skills of Young Women and Their Partner on Adjustment to Cancer (KALICOU3)

June 24, 2019 updated by: Centre Oscar Lambret

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

Unknown

Conditions

Intervention / Treatment

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 (Anticipated)

800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Angers, France, 49055
        • Recruiting
        • ICO-Site Paul Papin
        • Contact:
        • Principal Investigator:
          • Baptiste SAUTEREY, Dr
        • Sub-Investigator:
          • Mario CAMPONE, Pr
        • Sub-Investigator:
          • Sophie ABADIE-LACOURTOISIE, Dr
        • Sub-Investigator:
          • Elouen BOUGALHEM, Dr
        • Sub-Investigator:
          • Patrick SOULIE, Dr
        • Sub-Investigator:
          • Anne PATSOURIS, Dr
        • Sub-Investigator:
          • Caroline FONSEGRIVE, Dr
        • Sub-Investigator:
          • Paule AUGEREAU, Dr
      • Arras, France, 62000
        • Recruiting
        • Centre Marie Curie
        • Contact:
        • Principal Investigator:
          • Hassan RHLIOUCH, Dr
        • Sub-Investigator:
          • Alexandre HENNI, Dr
        • Sub-Investigator:
          • Philippe MITAL, Dr
        • Sub-Investigator:
          • Anne Sophie BLANC, Dr
      • Avignon, France, 84918
        • Recruiting
        • Institut Sainte Catherine
        • Contact:
        • Principal Investigator:
          • Gaetan de RAUGLAUDRE, Dr
        • Sub-Investigator:
          • Antoine ARNAUD, Dr
        • Sub-Investigator:
          • Alice MEGE, Dr
        • Sub-Investigator:
          • Julien GRENIER, Dr
      • Beuvry, France, 62660
        • Recruiting
        • Centre Pierre Curie - SCP de radiologie et d'imagerie médicale
        • Sub-Investigator:
          • Alexandre MARQUE, MD
        • Principal Investigator:
          • Aurélie FADIN, MD
        • Contact:
        • Sub-Investigator:
          • Jean-Briac PREVOST, MD
        • Sub-Investigator:
          • Mustapha FARES, MD
      • Bordeaux, France, 33077
        • Recruiting
        • Polyclinique Bordeaux Nord Aquitaine
        • Contact:
        • Principal Investigator:
          • Nadine DOHOLLOU, Dr
        • Sub-Investigator:
          • Caroline LENOIR, Dr
      • Boulogne-sur-Mer, France, 62321
      • Caen, France, 14036
        • Recruiting
        • Centre Francois Baclesse
        • Contact:
        • Principal Investigator:
          • Carine SEGURA, Dr
        • Sub-Investigator:
          • Christelle LEVY, Dr
        • Sub-Investigator:
          • Sabine NOAL, Dr
        • Sub-Investigator:
          • Ioana HRAB, Dr
        • Sub-Investigator:
          • Katharina GUNZER, Dr
        • Sub-Investigator:
          • Djelila ALLOUACHE, Dr
        • Sub-Investigator:
          • Corinne DELCAMBRE-LAIR, Dr
        • Sub-Investigator:
          • Serge DANHIER, Dr
        • Sub-Investigator:
          • Julien GEFFRELOT, Dr
        • Sub-Investigator:
          • Elodie COQUAN, Dr
      • Compiegne, France, 60200
        • Recruiting
        • Centre Hôpitalier de Compiègne Noyon
        • Contact:
        • Principal Investigator:
          • Julie VANBOCKSTAEL, Dr
        • Sub-Investigator:
          • Elie Casimir NGATCHOU TAENGA, Dr
      • Dechy, France, 59187
        • Recruiting
        • Centre Leonard de Vinci
        • Contact:
        • Principal Investigator:
          • Claire GIRAUD, Dr
        • Sub-Investigator:
          • Virginie POTTIER, Dr
      • Dijon, France, 21079
        • Recruiting
        • Centre Georges Francois Leclerc
        • Contact:
        • Principal Investigator:
          • Catherine LOUSTALOT, Dr
        • Sub-Investigator:
          • Sylvain CAUSERET, Dr
        • Sub-Investigator:
          • Charles COUTANT, Pr
        • Sub-Investigator:
          • Clémentine JANKOWSKI, Dr
      • Grenoble, France, 38043
        • Recruiting
        • Chu de Grenoble
        • Contact:
        • Principal Investigator:
          • Isabelle GABELLE FLANDRIN, Dr
      • Le Chesnay, France, 78150
        • Recruiting
        • Centre Hospitalier André Mignot
        • Contact:
        • Principal Investigator:
          • Christine ABRAHAM, Dr
        • Sub-Investigator:
          • Didier MAYEUR, Dr
        • Sub-Investigator:
          • Jean François GEAY, Dr
        • Sub-Investigator:
          • David BILLARD, Dr
      • Lille, France, 59020
        • Recruiting
        • Centre Oscar Lambret
        • Contact:
        • Principal Investigator:
          • Laurence VANLEMMENS, Dr
        • Sub-Investigator:
          • Jacques BONNETERRE, Pr
        • Sub-Investigator:
          • Véronique SERVENT, Dr
        • Sub-Investigator:
          • Audrey MAILLIEZ, Dr
        • Sub-Investigator:
          • Géraldine LAURIDANT, Dr
        • Sub-Investigator:
          • Nuria KOTECKI, Dr
      • Lille, France, 59037
        • Not yet recruiting
        • Chru De Lille
        • Contact:
        • Principal Investigator:
          • Christophe DESAUW, Dr
        • Sub-Investigator:
          • Anne PLOQUIN, Dr
      • Lille, France, 59000
        • Recruiting
        • Centre Bourgogne
        • Contact:
        • Principal Investigator:
          • Sylvie ROHART de CORDOUE, Dr
        • Sub-Investigator:
          • Patricia MAES, Dr
      • Marseille, France, 13273
        • Recruiting
        • Institut Paoli Calmettes
        • Contact:
        • Principal Investigator:
          • Magali PROVANSAL, Dr
        • Sub-Investigator:
          • Anthony GONCALVES, Dr
        • Sub-Investigator:
          • François BERTUCCI, Pr
        • Sub-Investigator:
          • Carole TARPIN, Dr
        • Sub-Investigator:
          • Jean Marc EXTRA, Dr
      • Maubeuge, France, 59603
        • Not yet recruiting
        • Centre Gray
        • Contact:
        • Principal Investigator:
          • Laurent GILBEAU, Dr
      • Montpellier, France, 34298
        • Recruiting
        • ICM Val d'Aurelle
        • Contact:
        • Principal Investigator:
          • Séverine GUIU, Dr
        • Sub-Investigator:
          • William JACOT, Dr
        • Sub-Investigator:
          • Véronique D'HONDT, Dr
        • Sub-Investigator:
          • Gilles ROMIEU, Dr
      • Nantes, France, 44202
        • Not yet recruiting
        • Le Confluent - Centre Catherine de Sienne
        • Contact:
        • Principal Investigator:
          • Alain LORTHOLARY, Dr
        • Sub-Investigator:
          • Claude EL KOURI, Dr
        • Sub-Investigator:
          • Hélène CASTANIE, Dr
      • Poitiers, France, 86021
        • Recruiting
        • CHU
        • Contact:
        • Principal Investigator:
          • Stéphanie CHIEZE, MD
        • Sub-Investigator:
          • Floriane MINNE, MD
        • Sub-Investigator:
          • Patrick BOUCHAERT, MD
      • Pontoise, France, 95300
        • Recruiting
        • CH René Dubos
        • Contact:
        • Principal Investigator:
          • Sophie VAUTIER-RIT, Dr
        • Sub-Investigator:
          • Hélène BERSENEFF, Dr
      • Reims, France, 51726
        • Recruiting
        • Institut Jean Godinot
        • Contact:
        • Principal Investigator:
          • Aude-Marie SAVOYE, Dr
        • Sub-Investigator:
          • Christelle JOUANNAUD, Dr
        • Sub-Investigator:
          • Brigitte COSTA, Dr
        • Sub-Investigator:
          • Gabriel YAZBEK, Dr
      • Reims, France, 51100
        • Recruiting
        • ICC Reims
        • Contact:
        • Principal Investigator:
          • Karinne PRULHIERE, Dr
        • Sub-Investigator:
          • David COEFFIC, Dr
      • Rennes, France, 35042
        • Recruiting
        • Centre Eugène Marquis
        • Contact:
        • Principal Investigator:
          • Claudia LEFEUVRE, Dr
        • Sub-Investigator:
          • Christophe PERRIN, Dr
        • Sub-Investigator:
          • Thibault de la MOTTE ROUGE, Dr
        • Sub-Investigator:
          • Fanny LE DU, Dr
      • Rouen, France, 76038
        • Recruiting
        • Centre Henri Becquerel
        • Contact:
        • Principal Investigator:
          • Cécile GUILLEMET, Dr
        • Sub-Investigator:
          • Marianne LEHEURTEUR, Dr
        • Sub-Investigator:
          • Florian CLATOT, Dr
        • Sub-Investigator:
          • Jean Christophe THERY, Dr
        • Sub-Investigator:
          • Corinne VEYRET-L'HOTE, Dr
      • Saint Brieuc, France, 22000
        • Recruiting
        • Hôpital Privé des Côtes d'Armor
        • Contact:
        • Principal Investigator:
          • Anne Claire HARDY-BESSON, Dr
        • Sub-Investigator:
          • Dominique BESSON, Dr
        • Sub-Investigator:
          • Pierre Luc ETIENNE, Dr
      • Saint Cloud, France, 92210
        • Recruiting
        • Institut curie-Hôpital Huguenin
        • Contact:
        • Principal Investigator:
          • Florence COUSSY, Dr
        • Sub-Investigator:
          • Etienne BRAIN, Dr
        • Sub-Investigator:
          • Florence LEREBOURG, Dr
        • Sub-Investigator:
          • Coraline DUBOT, Dr
        • Sub-Investigator:
          • Joy BACRI, Dr
        • Sub-Investigator:
          • Mony UNG, Dr
      • Saint Herblain, France, 44805
        • Recruiting
        • ICO- Istitut Gauducheau
        • Sub-Investigator:
          • Carole GOURMELON, Dr
        • Sub-Investigator:
          • Mario CAMPONE, Pr
        • Contact:
        • Principal Investigator:
          • Jean Sébastien FRENEL, Dr
        • Sub-Investigator:
          • Dominique BERTON RIGAUD, Dr
        • Sub-Investigator:
          • Mathilde CABART, Dr
        • Sub-Investigator:
          • Emmanuelle BOURBOULOUX, Dr
      • Toulouse, France, 31076
      • Tours, France, 37000
        • Recruiting
        • CHU Bretonneau
        • Principal Investigator:
          • Hélène VEGAS, Dr
        • Contact:
        • Sub-Investigator:
          • Claude LINASSIER, Pr
        • Sub-Investigator:
          • Marie Agnès BY, Dr
        • Sub-Investigator:
          • Catherine BARBE, Dr
      • Valenciennes, France, 59300
        • Not yet recruiting
        • Centre de cancérologie des Dentellières
        • Contact:
        • Principal Investigator:
          • Jessica GROSJEAN, Dr
      • Valenciennes, France, 59300
        • Recruiting
        • CH Valenciennes
        • Contact:
        • Principal Investigator:
          • Claudine CORNEA, Dr
        • Sub-Investigator:
          • Isabelle BONNET-LEGRAND, Dr
      • Villeneuve D'ascq, France, 59657
        • Recruiting
        • Hopital Prive de Villeneuve d'Ascq
        • Contact:
        • Principal Investigator:
          • Olivier ROMANO, Dr
        • Sub-Investigator:
          • Nathalie LEMOINE, Dr
        • Sub-Investigator:
          • Frédéric CAQUANT, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
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
an average of 1 year
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
an average of 1 year
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
an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BCI-YW
Time Frame: an average of 1 year
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
Time Frame: an average of 1 year
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)
Time Frame: an average of 1 year
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
Time Frame: an average of 1 year
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
Time Frame: an average of 1 year
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)
Time Frame: an average of 1 year
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

This is where you will find people and organizations involved with this study.

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: VANLEMMENS Laurence, MD, Oscar Lambret
  • Study Director: Christophe Véronique, Pr, Université Lille 3

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2016

Primary Completion (Anticipated)

January 1, 2021

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

July 29, 2016

First Submitted That Met QC Criteria

August 5, 2016

First Posted (Estimate)

August 10, 2016

Study Record Updates

Last Update Posted (Actual)

June 26, 2019

Last Update Submitted That Met QC Criteria

June 24, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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