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

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ClinicalTrials.gov Identifier: NCT02861742
Recruitment Status : Recruiting
First Posted : August 10, 2016
Last Update Posted : June 26, 2019
Sponsor:
Collaborators:
Université Lille 3
Aix Marseille Université
University of Paris 5 - Rene Descartes
SIRIC ONCOLille
Canceropôle Nord Ouest
National Cancer Institute, France
Information provided by (Responsible Party):
Centre Oscar Lambret

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.

Condition or disease Intervention/treatment Phase
Aging Breast Cancer 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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : July 25, 2016
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02861742


Contacts
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Contact: Decoupigny Emilie +33 (0) 3 20 29 59 18 e-decoupigny@o-lambret.fr
Contact: VANLEMMENS Laurence, MD +33 (0) 3 20 29 59 18 l-vanlemmens@o-lambret.fr

Locations
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France
ICO-Site Paul Papin Recruiting
Angers, France, 49055
Contact: Baptiste SAUTEREY, Dr    02 41 35 27 20    baptiste.sauterey@ico.unicancer.fr   
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         
Centre Marie Curie Recruiting
Arras, France, 62000
Contact: Hassan RHLIOUCH, Dr    03 21 21 03 28    drrhliouch@radiopole-artois.com   
Principal Investigator: Hassan RHLIOUCH, Dr         
Sub-Investigator: Alexandre HENNI, Dr         
Sub-Investigator: Philippe MITAL, Dr         
Sub-Investigator: Anne Sophie BLANC, Dr         
Institut Sainte Catherine Recruiting
Avignon, France, 84918
Contact: Gaetan de RAUGLAUDRE, Dr    04 90 27 61 61    g.derauglaudre@isc84.org   
Principal Investigator: Gaetan de RAUGLAUDRE, Dr         
Sub-Investigator: Antoine ARNAUD, Dr         
Sub-Investigator: Alice MEGE, Dr         
Sub-Investigator: Julien GRENIER, Dr         
Centre Pierre Curie - SCP de radiologie et d'imagerie médicale Recruiting
Beuvry, France, 62660
Contact: Aurélie FADIN    +33 3 21 61 92 83    afadin@radiopole-artois.com   
Principal Investigator: Aurélie FADIN, MD         
Sub-Investigator: Jean-Briac PREVOST, MD         
Sub-Investigator: Mustapha FARES, MD         
Sub-Investigator: Alexandre MARQUE, MD         
Polyclinique Bordeaux Nord Aquitaine Recruiting
Bordeaux, France, 33077
Contact: Nadine DOHOLLOU, Dr    05 56 43 73 54    n.dohollou@bordeauxnord.com   
Principal Investigator: Nadine DOHOLLOU, Dr         
Sub-Investigator: Caroline LENOIR, Dr         
CH de BOULOGNE-SUR-MER Recruiting
Boulogne-sur-Mer, France, 62321
Contact: Abeer NAJEM, MD       a.najeem@ch-boulogne.fr   
Centre François Baclesse Recruiting
Caen, France, 14036
Contact: Carine SEGURA, Dr    02 31 45 50 02    c.segura@baclesse-unicancer.fr   
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         
Centre Hôpitalier de Compiègne Noyon Recruiting
Compiegne, France, 60200
Contact: Julie VANBOCKSTAEL, Dr    03 44 23 60 00    j.vanbockstael@ch-compiegnenoyon.fr   
Principal Investigator: Julie VANBOCKSTAEL, Dr         
Sub-Investigator: Elie Casimir NGATCHOU TAENGA, Dr         
Centre Léonard de Vinci Recruiting
Dechy, France, 59187
Contact: Claire GIRAUD, Dr    03 27 08 60 63    cgiraud@clinique-psv.fr   
Principal Investigator: Claire GIRAUD, Dr         
Sub-Investigator: Virginie POTTIER, Dr         
Centre Georges François Leclerc Recruiting
Dijon, France, 21079
Contact: Catherine LOUSTALOT, Dr    03 80 73 75 08    cloustalot@cgfl.fr   
Principal Investigator: Catherine LOUSTALOT, Dr         
Sub-Investigator: Sylvain CAUSERET, Dr         
Sub-Investigator: Charles COUTANT, Pr         
Sub-Investigator: Clémentine JANKOWSKI, Dr         
CHU de Grenoble Recruiting
Grenoble, France, 38043
Contact: Isabelle GABELLE FLANDRIN, Dr    04 76 76 54 35    igabelleflandrin@chu-grenoble.fr   
Principal Investigator: Isabelle GABELLE FLANDRIN, Dr         
Centre Hospitalier André Mignot Recruiting
Le Chesnay, France, 78150
Contact: Christine ABRAHAM, Dr    01 39 63 91 33    cabraham@ch-versailles.fr   
Principal Investigator: Christine ABRAHAM, Dr         
Sub-Investigator: Didier MAYEUR, Dr         
Sub-Investigator: Jean François GEAY, Dr         
Sub-Investigator: David BILLARD, Dr         
Centre Bourgogne Recruiting
Lille, France, 59000
Contact: Sylvie ROHART de CORDOUE, Dr    03 20 00 97 57    sdecordoue@centre-bourgogne.com   
Principal Investigator: Sylvie ROHART de CORDOUE, Dr         
Sub-Investigator: Patricia MAES, Dr         
Centre Oscar Lambret Recruiting
Lille, France, 59020
Contact: Laurence VANLEMMENS, Dr    03 20 29 59 18    l-vanlemmens@o-lambret.fr   
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         
CHRU de Lille Not yet recruiting
Lille, France, 59037
Contact: Christophe DESAUW, Dr    03 20 44 54 61    christophe.desauw@chru-lille.fr   
Principal Investigator: Christophe DESAUW, Dr         
Sub-Investigator: Anne PLOQUIN, Dr         
Institut Paoli Calmettes Recruiting
Marseille, France, 13273
Contact: Magali PROVANSAL, Dr    04 91 22 37 40    PROVANSALM@ipc.unicancer.fr   
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         
Centre Gray Not yet recruiting
Maubeuge, France, 59603
Contact: Laurent GILBEAU, Dr    03 27 69 83 83    gilbeau.laurent@gmail.com   
Principal Investigator: Laurent GILBEAU, Dr         
ICM Val d'Aurelle Recruiting
Montpellier, France, 34298
Contact: Séverine GUIU, Dr    04 67 61 30 43    severine.guiu@icm.unicancer.fr   
Principal Investigator: Séverine GUIU, Dr         
Sub-Investigator: William JACOT, Dr         
Sub-Investigator: Véronique D'HONDT, Dr         
Sub-Investigator: Gilles ROMIEU, Dr         
Le Confluent - Centre Catherine de Sienne Not yet recruiting
Nantes, France, 44202
Contact: Alain LORTHOLARY, Dr    02 28 27 21 71    lortholary.alain@catherinedesienne.fr   
Principal Investigator: Alain LORTHOLARY, Dr         
Sub-Investigator: Claude EL KOURI, Dr         
Sub-Investigator: Hélène CASTANIE, Dr         
CHU Recruiting
Poitiers, France, 86021
Contact: Stéphanie CHIEZE, MD    +33 5 49 44 48 71    stephanie.chieze@chu-poitiers.fr   
Principal Investigator: Stéphanie CHIEZE, MD         
Sub-Investigator: Floriane MINNE, MD         
Sub-Investigator: Patrick BOUCHAERT, MD         
CH René Dubos Recruiting
Pontoise, France, 95300
Contact: Sophie VAUTIER-RIT, Dr    01 30 75 44 48    sophie.vautier-rit@ch-pontoise.fr   
Principal Investigator: Sophie VAUTIER-RIT, Dr         
Sub-Investigator: Hélène BERSENEFF, Dr         
ICC Reims Recruiting
Reims, France, 51100
Contact: Karinne PRULHIERE, Dr    03 26 84 02 84    kprulhiere@iccreims.fr   
Principal Investigator: Karinne PRULHIERE, Dr         
Sub-Investigator: David COEFFIC, Dr         
Institut Jean Godinot Recruiting
Reims, France, 51726
Contact: Aude-Marie SAVOYE, Dr    03 26 50 43 84    aude-marie.savoye@reims.unicancer.fr   
Principal Investigator: Aude-Marie SAVOYE, Dr         
Sub-Investigator: Christelle JOUANNAUD, Dr         
Sub-Investigator: Brigitte COSTA, Dr         
Sub-Investigator: Gabriel YAZBEK, Dr         
Centre Eugène Marquis Recruiting
Rennes, France, 35042
Contact: Claudia LEFEUVRE, Dr    02 99 25 30 00    c.lefeuvre@unicancer.fr   
Principal Investigator: Claudia LEFEUVRE, Dr         
Sub-Investigator: Christophe PERRIN, Dr         
Sub-Investigator: Thibault de la MOTTE ROUGE, Dr         
Sub-Investigator: Fanny LE DU, Dr         
Centre Henri Becquerel Recruiting
Rouen, France, 76038
Contact: Cécile GUILLEMET, Dr    02 32 08 22 38    cecile.guillemet@chb.unicancer.fr   
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         
Hôpital Privé des Côtes d'Armor Recruiting
Saint Brieuc, France, 22000
Contact: Anne Claire HARDY-BESSON, Dr    02 96 75 22 16    ac.hardy@cario-sante.fr   
Principal Investigator: Anne Claire HARDY-BESSON, Dr         
Sub-Investigator: Dominique BESSON, Dr         
Sub-Investigator: Pierre Luc ETIENNE, Dr         
Institut curie-Hôpital Huguenin Recruiting
Saint Cloud, France, 92210
Contact: Florence COUSSY, Dr    01 47 11 15 15    lorence.coussy@curie.fr   
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         
ICO- Istitut Gauducheau Recruiting
Saint Herblain, France, 44805
Contact: Jean Sébastien FRENEL, Dr    02 40 67 99 00    jean-sebastien.frenel@ico.unicancer.fr   
Principal Investigator: Jean Sébastien FRENEL, Dr         
Sub-Investigator: Mario CAMPONE, Pr         
Sub-Investigator: Dominique BERTON RIGAUD, Dr         
Sub-Investigator: Mathilde CABART, Dr         
Sub-Investigator: Carole GOURMELON, Dr         
Sub-Investigator: Emmanuelle BOURBOULOUX, Dr         
Unité d'Oncologie et d'hématologie ONCOSUD Recruiting
Toulouse, France, 31076
Contact: Raymond DESPAX, MD       despax@clinique-pasteur.com   
CHU Bretonneau Recruiting
Tours, France, 37000
Contact: Hélène VEGAS, Dr    02 47 47 99 19    h.vegas@chu-tours.fr   
Principal Investigator: Hélène VEGAS, Dr         
Sub-Investigator: Claude LINASSIER, Pr         
Sub-Investigator: Marie Agnès BY, Dr         
Sub-Investigator: Catherine BARBE, Dr         
Centre de Cancérologie des Dentellières Not yet recruiting
Valenciennes, France, 59300
Contact: Jessica GROSJEAN, Dr    03 66 22 70 44    jessgrosjean@gmail.com   
Principal Investigator: Jessica GROSJEAN, Dr         
CH Valenciennes Recruiting
Valenciennes, France, 59300
Contact: Claudine CORNEA, Dr    03 27 14 05 40    cornea-cl@ch-valenciennes.fr   
Principal Investigator: Claudine CORNEA, Dr         
Sub-Investigator: Isabelle BONNET-LEGRAND, Dr         
Hôpital Privé de Villeneuve d'Ascq Recruiting
Villeneuve D'ascq, France, 59657
Contact: Olivier ROMANO, Dr    03 20 99 56 90    romanoolivier@yahoo.fr   
Principal Investigator: Olivier ROMANO, Dr         
Sub-Investigator: Nathalie LEMOINE, Dr         
Sub-Investigator: Frédéric CAQUANT, Dr         
Sponsors and Collaborators
Centre Oscar Lambret
Université Lille 3
Aix Marseille Université
University of Paris 5 - Rene Descartes
SIRIC ONCOLille
Canceropôle Nord Ouest
National Cancer Institute, France
Investigators
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Principal Investigator: VANLEMMENS Laurence, MD Oscar Lambret
Study Director: Christophe Véronique, Pr Université Lille 3

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Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT02861742     History of Changes
Other Study ID Numbers: KALICOU 3-1509
2015-A01808-41 ( Other Identifier: ANSM )
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases