Delivery of questionnaires
OtherAfter 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.
NCT Number: NCT02861742
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.
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Notify Me18 year–45 year
All sexes
Interventional
Not applicable
ICO-Site Paul Papin, Angers, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: an average of 1 year
To evaluate the dyadic effect's emotional skills on adjustment to cancer as well as on partner
Time frame: an average of 1 year
To evaluate the dyadic effect's emotional skills on adjustment to cancer as well as on partner
Centre Oscar Lambret
Other
Evaluation of the Impact of Emotional Skills of Young Women (≤ 45 Years), With Non-metastatic Breast Cancer, and Their Partner on Adjustment to Cancer
Acronym: KALICOU3
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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