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

Centre Oscar Lambret

Status: Unknown

Conditions: Breast Cancer; Aging

Treatments: Behavioral: Questionnaire T3 to fill; Behavioral: Questionnaire T5 to fill; Behavioral: Questionnaire T1 to fill; Behavioral: Questionnaire T2 to fill; Behavioral: Questionnaire T4 to fill; Other: Delivery of questionnaires

Study type: Interventional

Funder types: Other

Identifiers

NCT02861742

2015-A01808-41 (Other Identifier)

KALICOU 3-1509

Details and patient eligibility

About

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.

Full 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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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800 participants in 1 patient group

Study procedure

Other group

Description:

Delivery of questionnaires, Questionnaire T1 to fill, Questionnaire T2 to fill, Questionnaire T3 to fill, Questionnaire T4 to fill, Questionnaire T5 to fill

Treatment:

Other: Delivery of questionnaires

Behavioral: Questionnaire T2 to fill

Behavioral: Questionnaire T3 to fill

Behavioral: Questionnaire T1 to fill

Behavioral: Questionnaire T4 to fill

Behavioral: Questionnaire T5 to fill