An interventional study of Delivery of questionnaires and Questionnaire T1 to fill in Aging and Breast Cancer, sponsored by Centre Oscar Lambret. Completed at 32 sites in France. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-03-18.
Sponsored by Centre Oscar Lambret · Not applicable, Interventional, and Other
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 391 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Centre Oscar Lambret is the lead sponsor of 127 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
Delivery of questionnaires, Questionnaire T1 to fill, Questionnaire T2 to fill, Questionnaire T3 to fill, Questionnaire T4 to fill, Questionnaire T5 to fill
Other: Delivery of questionnaires · Behavioral: Questionnaire T1 to fill · Behavioral: Questionnaire T2 to fill · Behavioral: Questionnaire T3 to fill · Behavioral: Questionnaire T4 to fill · Behavioral: Questionnaire T5 to fill
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.
T1 is to fill before chemotherapy.
T2 is to fill after the 6th cycle of chemotherapy.
T3 is to fill at the end of radiotherapy.
T4 is to fill 4 month after beginning of hormonotherapy or surveillance if no hormonotherapy.
T5 is to fill 1 year after the beginning of hormonotherapy or surveillance if no hormonotherapy.
BCI-YW ( Breast Cancer Inventory - Young Women)
To evaluate the effect of emotional skills of patients and partners on their individual disease subjective experience during care pathways, from chemotherapy to surveillance
Time frame: an average of 1 year
BCI-Partner's YW ( Breast Cancer Inventory - Young Women Partner's)
To evaluate the effect of emotional skills of patients and partners on their individual disease subjective experience during care pathways, from chemotherapy to surveillance
Time frame: an average of 1 year
PEC (Profile of Emotional Competences)
To evaluate the effect of emotional skills of patients and partners on their individual disease subjective experience during care pathways, from chemotherapy to surveillance
Time frame: an average of 1 year
BCI-YW
To evaluate the dyadic effect's emotional skills and treatment repercussion on adjustment to cancer as well as on partner
Time frame: an average of 1 year
BCI-Partner's YW
To evaluate the dyadic effect's emotional skills and treatment repercussion on adjustment to cancer as well as on partner
Time frame: an average of 1 year
SF 36 (Short Form 36 - Health Survey)
To evaluate the dyadic effect's emotional skills and treatment repercussion on adjustment to cancer as well as on partner
Time frame: an average of 1 year
Hospital Anxiety-Depression Scale
To evaluate the dyadic effect's emotional skills and treatment repercussion on adjustment to cancer as well as on partner
Time frame: an average of 1 year
Profile of Emotional Competences
To evaluate the dyadic effect's emotional skills on adjustment to cancer as well as on partner
Time frame: an average of 1 year
MAVA (Measure of affectivity: Valence/Activation)
To evaluate the dyadic effect's emotional skills on adjustment to cancer as well as on partner
Time frame: an average of 1 year
Plan to share: No
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Centre Oscar Lambret