跳至主要内容
临床试验/NCT02861742
NCT02861742已完成不适用

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

Centre Oscar Lambret32 个研究点 分布在 1 个国家目标入组 391 人开始时间: 2016年7月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
391
试验地点
32
主要终点
BCI-YW ( Breast Cancer Inventory - Young Women)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •Psychological or physical inability to fill questionnaire
  • •Patient under guardianship

研究组 & 干预措施

Study procedure

Other

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

干预措施: Delivery of questionnaires (Other)

Study procedure

Other

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

干预措施: Questionnaire T1 to fill (Behavioral)

Study procedure

Other

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

干预措施: Questionnaire T2 to fill (Behavioral)

Study procedure

Other

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

干预措施: Questionnaire T3 to fill (Behavioral)

Study procedure

Other

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

干预措施: Questionnaire T4 to fill (Behavioral)

Study procedure

Other

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

干预措施: Questionnaire T5 to fill (Behavioral)

结局指标

主要结局

BCI-YW ( Breast Cancer Inventory - Young Women)

时间窗: 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)

时间窗: 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)

时间窗: 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

次要结局

  • BCI-Partner's YW(an average of 1 year)
  • Hospital Anxiety-Depression Scale(an average of 1 year)
  • MAVA (Measure of affectivity: Valence/Activation)(an average of 1 year)
  • BCI-YW(an average of 1 year)
  • Profile of Emotional Competences(an average of 1 year)
  • SF 36 (Short Form 36 - Health Survey)(an average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (32)

Loading locations...

相似试验