Clinical trial NCT02861742: Impact of Emotional Skills of Young Women and Their Partner on Adjustment to Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aging
Breast Cancer
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
Collaborators: name: Université Lille 3
name: Aix Marseille Université
name: University of Paris 5 - Rene Descartes
name: SIRIC ONCOLille
name: Canceropôle Nord Ouest
name: National Cancer Institute, France
First posted: 2016-08-10
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: BCI-YW ( Breast Cancer Inventory - Young Women)
timeFrame: an average of 1 year
measure: BCI-Partner's YW ( Breast Cancer Inventory - Young Women Partner's)
timeFrame: an average of 1 year
measure: PEC (Profile of Emotional Competences)
timeFrame: an average of 1 year
Secondary outcomes:
measure: BCI-YW
timeFrame: an average of 1 year
measure: BCI-Partner's YW
timeFrame: an average of 1 year
measure: SF 36 (Short Form 36 - Health Survey)
timeFrame: an average of 1 year
measure: Hospital Anxiety-Depression Scale
timeFrame: an average of 1 year
measure: Profile of Emotional Competences
timeFrame: an average of 1 year
measure: MAVA (Measure of affectivity: Valence/Activation)
timeFrame: an average of 1 year
Other outcomes:
Locations:
city: Angers
country: France
facility: ICO-Site Paul Papin
city: Arras
country: France
facility: Centre Marie Curie
city: Avignon
country: France
facility: Institut Sainte Catherine
city: Beuvry
country: France
facility: Centre Pierre Curie - SCP de radiologie et d'imagerie médicale
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine
city: Boulogne-sur-Mer
country: France
facility: CH de BOULOGNE-SUR-MER
city: Caen
country: France
facility: Centre François Baclesse
city: Compiegne
country: France
facility: Centre Hôpitalier de Compiègne Noyon
city: Dechy
country: France
facility: Centre Léonard de Vinci
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Grenoble
country: France
facility: CHU de Grenoble
city: Le Chesnay
country: France
facility: Centre Hospitalier André Mignot
city: Lille
country: France
facility: Centre Bourgogne
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lille
country: France
facility: CHRU de Lille
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Maubeuge
country: France
facility: Centre Gray
city: Montpellier
country: France
facility: ICM Val d'Aurelle
city: Nantes
country: France
facility: Le Confluent - Centre Catherine de Sienne
city: Poitiers
country: France
facility: CHU
city: Pontoise
country: France
facility: CH René Dubos
city: Reims
country: France
facility: ICC Reims
city: Reims
country: France
facility: Institut Jean Godinot
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Saint Brieuc
country: France
facility: Hôpital Privé des Côtes d'Armor
city: Saint Cloud
country: France
facility: Institut curie-Hôpital Huguenin
city: Saint Herblain
country: France
facility: ICO- Istitut Gauducheau
city: Toulouse
country: France
facility: Unité d'Oncologie et d'hématologie ONCOSUD
city: Tours
country: France
facility: CHU Bretonneau
city: Valenciennes
country: France
facility: Centre de Cancérologie des Dentellières
city: Valenciennes
country: France
facility: CH Valenciennes
city: Villeneuve D'ascq
country: France
facility: Hôpital Privé de Villeneuve d'Ascq
Study officials:
affiliation: Oscar Lambret
name: VANLEMMENS Laurence, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Université Lille 3
name: Christophe Véronique, Pr
role: STUDY_DIRECTOR
References: