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

Not Applicable

• Conditions: Aging; Breast Cancer

• 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.

Study Timeline

• Study Start: 2016-07-25
• Study First Submitted: 2016-07-29
• Study First Submitted QC: 2016-08-05
• Study First Posted: 2016-08-10
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-24
• Last Update Posted: 2019-06-26
• Primary Completion: 2021-01
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 800

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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)

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

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