Risk and Protective Factors for Depression and Body Image Distress Following Mastectomy With Breast Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Beck Depression Inventory-II (BDI-II)
研究概览
简要总结
Mastectomy is a major surgery that can have a profound effect on women's psychosocial wellbeing, including elevated depression and body image distress. Reconstructive breast surgery aims to improve patients' psychosocial adjustment to mastectomy, yet for some women substantial distress persists after reconstruction. However, very little is known about risk or protective factors for persistent depression or body image distress following mastectomy with reconstruction. The present study aims to address this critical gap. In women undergoing mastectomy with breast reconstruction, the investigators will assess risk and protective factors for post-surgery depression severity and body image distress.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Female adults (age 18+) who are scheduled for mastectomy with immediate breast reconstruction at the Massachusetts General Hospital (MGH) Plastic and Reconstructive Surgery Program
- •English language proficiency
- •Ability to provide informed consent.
排除标准
- •Current psychotic disorder, manic episode, serious neurological disorder, intellectual disability, or developmental disorder
- •Current active suicidal ideation
- •Current treatment plan includes radiation and/or ongoing chemotherapy
- •Does not have access to Internet at home, required to complete study questionnaires
结局指标
主要结局
Beck Depression Inventory-II (BDI-II)
时间窗: 2-3 months post-surgery (i.e., Time 2)
Assesses severity of depressive symptoms with a summed total score, which ranges from 0 (no depressive symptoms) to 63 (severe depressive symptoms).
Body Image Scale (BIS)
时间窗: 2-3 months post-surgery (i.e., Time 2)
Assesses severity of body image distress related to breast cancer treatment with a summed total score, which ranges from 0 (no body image distress) to 30 (substantial body image distress).
次要结局
未报告次要终点
研究者
Hilary Weingarden
Psychologist
Massachusetts General Hospital