Impact of Emotional Skills of Young Women and Their Partner on Adjustment to Cancer
- Conditions
- AgingBreast Cancer
- Interventions
- Other: Delivery of questionnairesBehavioral: Questionnaire T1 to fillBehavioral: Questionnaire T2 to fillBehavioral: Questionnaire T3 to fillBehavioral: Questionnaire T4 to fillBehavioral: Questionnaire T5 to fill
- Registration Number
- NCT02861742
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 800
- 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
- Psychological or physical inability to fill questionnaire
- Patient under guardianship
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Study procedure Delivery of questionnaires Delivery of questionnaires, Questionnaire T1 to fill, Questionnaire T2 to fill, Questionnaire T3 to fill, Questionnaire T4 to fill, Questionnaire T5 to fill Study procedure Questionnaire T5 to fill Delivery of questionnaires, Questionnaire T1 to fill, Questionnaire T2 to fill, Questionnaire T3 to fill, Questionnaire T4 to fill, Questionnaire T5 to fill Study procedure Questionnaire T1 to fill Delivery of questionnaires, Questionnaire T1 to fill, Questionnaire T2 to fill, Questionnaire T3 to fill, Questionnaire T4 to fill, Questionnaire T5 to fill Study procedure Questionnaire T2 to fill Delivery of questionnaires, Questionnaire T1 to fill, Questionnaire T2 to fill, Questionnaire T3 to fill, Questionnaire T4 to fill, Questionnaire T5 to fill Study procedure Questionnaire T3 to fill Delivery of questionnaires, Questionnaire T1 to fill, Questionnaire T2 to fill, Questionnaire T3 to fill, Questionnaire T4 to fill, Questionnaire T5 to fill Study procedure Questionnaire T4 to fill Delivery of questionnaires, Questionnaire T1 to fill, Questionnaire T2 to fill, Questionnaire T3 to fill, Questionnaire T4 to fill, Questionnaire T5 to fill
- Primary Outcome Measures
Name Time Method BCI-YW ( Breast Cancer Inventory - Young Women) 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
BCI-Partner's YW ( Breast Cancer Inventory - Young Women Partner's) 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
PEC (Profile of Emotional Competences) 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
Name Time Method BCI-Partner's YW 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
Hospital Anxiety-Depression Scale 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
MAVA (Measure of affectivity: Valence/Activation) an average of 1 year To evaluate the dyadic effect's emotional skills on adjustment to cancer as well as on partner
BCI-YW 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
Profile of Emotional Competences an average of 1 year To evaluate the dyadic effect's emotional skills on adjustment to cancer as well as on partner
SF 36 (Short Form 36 - Health Survey) 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
Trial Locations
- Locations (33)
Centre Georges François Leclerc
🇫🇷Dijon, France
Centre Bourgogne
🇫🇷Lille, France
Polyclinique Bordeaux Nord Aquitaine
🇫🇷Bordeaux, France
CHU de Grenoble
🇫🇷Grenoble, France
Centre Hôpitalier de Compiègne Noyon
🇫🇷Compiegne, France
Centre Gray
🇫🇷Maubeuge, France
Centre Hospitalier André Mignot
🇫🇷Le Chesnay, France
Centre Oscar Lambret
🇫🇷Lille, France
CHRU de Lille
🇫🇷Lille, France
Institut Jean Godinot
🇫🇷Reims, France
CH Valenciennes
🇫🇷Valenciennes, France
ICO-Site Paul Papin
🇫🇷Angers, France
Institut Sainte Catherine
🇫🇷Avignon, France
Centre Marie Curie
🇫🇷Arras, France
CH de BOULOGNE-SUR-MER
🇫🇷Boulogne-sur-Mer, France
Centre Pierre Curie - SCP de radiologie et d'imagerie médicale
🇫🇷Beuvry, France
Centre François Baclesse
🇫🇷Caen, France
Centre Léonard de Vinci
🇫🇷Dechy, France
Institut curie-Hôpital Huguenin
🇫🇷Saint Cloud, France
Institut Paoli Calmettes
🇫🇷Marseille, 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
Centre Eugène Marquis
🇫🇷Rennes, France
Centre Henri Becquerel
🇫🇷Rouen, France
Hôpital Privé des Côtes d'Armor
🇫🇷Saint Brieuc, 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
Hôpital Privé de Villeneuve d'Ascq
🇫🇷Villeneuve D'ascq, France