Aging, Breast Cancer
Conditions
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.
Interventions
OTHERDelivery 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.
BEHAVIORALQuestionnaire T1 to fill
T1 is to fill before chemotherapy.
BEHAVIORALQuestionnaire T2 to fill
T2 is to fill after the 6th cycle of chemotherapy.
BEHAVIORALQuestionnaire T3 to fill
T3 is to fill at the end of radiotherapy.
BEHAVIORALQuestionnaire T4 to fill
T4 is to fill 4 month after beginning of hormonotherapy or surveillance if no hormonotherapy.
BEHAVIORALQuestionnaire T5 to fill
T5 is to fill 1 year after the beginning of hormonotherapy or surveillance if no hormonotherapy.
Sponsors
Centre Oscar Lambret
Université Lille 3
Aix Marseille Université
University of Paris 5 - Rene Descartes
SIRIC ONCOLille
Canceropôle Nord Ouest
National Cancer Institute, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORLaurence VANLEMMENS, MD
Oscar Lambret
STUDY_DIRECTORVéronique CHRISTOPHE, PhD
Université Lille 3
Outcome results
None listed