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

Breast Cancer Clinical Trial

— KALICOU3  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02861742
• Other study ID #: KALICOU 3-1509
• Secondary ID: 2015-A01808-41
• Status: Recruiting
• Phase: N/A
• Start date: July 25, 2016
• Est. completion date: July 2021

Study information

• Verified date: June 2019
• Source: Centre Oscar Lambret
• Contact: Decoupigny Emilie
• Phone: +33 (0) 3 20 29 59 18
• Email: e-decoupigny[@]o-lambret.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: July 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Breast Cancer
• Breast Neoplasms

Intervention

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.
• Questionnaire T2 to fill
T2 is to fill after the 6th cycle of chemotherapy.
• Questionnaire T3 to fill
T3 is to fill at the end of radiotherapy.
• Questionnaire T4 to fill
T4 is to fill 4 month after beginning of hormonotherapy or surveillance if no hormonotherapy.
• Questionnaire T5 to fill
T5 is to fill 1 year after the beginning of hormonotherapy or surveillance if no hormonotherapy.

Locations

Country	Name	City	State
France	ICO-Site Paul Papin	Angers
France	Centre Marie Curie	Arras
France	Institut Sainte Catherine	Avignon
France	Centre Pierre Curie - SCP de radiologie et d'imagerie médicale	Beuvry
France	Polyclinique Bordeaux Nord Aquitaine	Bordeaux
France	CH de BOULOGNE-SUR-MER	Boulogne-sur-Mer
France	Centre François Baclesse	Caen
France	Centre Hôpitalier de Compiègne Noyon	Compiegne
France	Centre Léonard de Vinci	Dechy
France	Centre Georges François Leclerc	Dijon
France	CHU de Grenoble	Grenoble
France	Centre Hospitalier André Mignot	Le Chesnay
France	Centre Bourgogne	Lille
France	Centre Oscar Lambret	Lille
France	CHRU de Lille	Lille
France	Institut Paoli Calmettes	Marseille
France	Centre Gray	Maubeuge
France	ICM Val d'Aurelle	Montpellier
France	Le Confluent - Centre Catherine de Sienne	Nantes
France	CHU	Poitiers
France	CH René Dubos	Pontoise
France	ICC Reims	Reims
France	Institut Jean Godinot	Reims
France	Centre Eugène Marquis	Rennes
France	Centre Henri Becquerel	Rouen
France	Hôpital Privé des Côtes d'Armor	Saint Brieuc
France	Institut curie-Hôpital Huguenin	Saint Cloud
France	ICO- Istitut Gauducheau	Saint Herblain
France	Unité d'Oncologie et d'hématologie ONCOSUD	Toulouse
France	CHU Bretonneau	Tours
France	Centre de Cancérologie des Dentellières	Valenciennes
France	CH Valenciennes	Valenciennes
France	Hôpital Privé de Villeneuve d'Ascq	Villeneuve D'ascq

Sponsors (7)

Lead Sponsor	Collaborator
Centre Oscar Lambret	Aix Marseille Université, Canceropôle Nord Ouest, National Cancer Institute, France, SIRIC ONCOLille, Université Lille 3, University of Paris 5 - Rene Descartes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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