NCT02861742

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

Evaluation of the Impact of Emotional Skills of Young Women (≤ 45 Years), With Non-metastatic Breast Cancer, and Their Partner on Adjustment to Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 391 (actual)
• Sponsor: Centre Oscar Lambret · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aging
• Breast Cancer

Interventions

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

Timeline

• Start date: 2016-07-25
• Primary completion: 2021-06-01
• Completion: 2022-01-01
• First posted: 2016-08-10
• Last updated: 2026-03-18

Locations

32 sites across 1 country: France