Psychological Effects of Implant Loss
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Experiences and psychological effects of implant loss after immediate breast reconstruction
研究概览
简要总结
Previous quality of life studies have suggested that long term satisfaction with breast reconstruction may be affected by postoperative complications. Complication frequencies, especially the risk for implant loss, is considerably higher in immediate than in delayed breast reconstruction. Knowledge about how implant loss affects the patient's experience of her breast reconstruction can guide us in the choice between immediate and delayed breast reconstruction in high risk patients and help us better prepare the patients for possible complications. This study will investigate patients' experiences with losing an implant in connection with immediate breast reconstruction.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Biological women
- •Age >18 years
- •Have lost an implant after a mastectomy and immediate breast reconstruction
排除标准
- •Inability to give informed consent
- •inability to speak and understand Swedish
- •relapse of breast cancer after the reconstruction
- •metastatic disease
- •psychiatric co-morbidity.
结局指标
主要结局
Experiences and psychological effects of implant loss after immediate breast reconstruction
时间窗: 10 years
Interviews
Effect on quality of life of implant loss: scale
时间窗: 10 years
Breast-Q reconstruction post-operative. It includes different domains: health-related quality of life (HR-QOL; including physical, psychosocial, and sexual well-being) and patient satisfaction (including satisfaction with breasts, outcome, and care). Each scale produces an independent score from 0-100.a higher score means greater satisfaction or better QOL
Effect on body image of implant loss
时间窗: 10 years
Body-Esteem Scale for Adolescents and Adults (BESAA). It consists of three subscales: BE-appearance, BE-weight and BE-attribution.The scale has 23 items and the respondents indicated their degree of agreement on a 5-point Likert scale ranging from 0 (never) to 4 (always).High score indicates higher dimensions of the Body Esteem.
Effect on depression and anxiety of implant loss
时间窗: 10 years
Hospital Anxiety and Depression scale (HAD).The HADS is a fourteen item scale that generates: Seven of the items relate to anxiety and seven relate to depression.For both scales, scores of less than 7 indicate non-cases. 8-10 mild, 11-14 moderate, 15-21 severe.
Coping strategies
时间窗: 10 years
The Life orientation test - revised (Lot-R) is a 10-item scale that measures how optimistic or pessimistic people feel about the future. High values imply optimism.
次要结局
未报告次要终点