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临床试验/NCT04733482
NCT04733482已完成不适用

The Effects of Cosmetic Care on Body Image in Young Chinese Breast Cancer Patients Receiving Chemotherapy

Zhenqi Lu1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2015年1月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
76
试验地点
1
主要终点
Social avoidance and distress scale

研究概览

简要总结

This study aimed to explore the effects of cosmetic care on body image (BI), and social avoidance and distress (SAD) in young Chinese breast cancer patients, aged 18-40 years old, receiving adjuvant chemotherapy. This was a single-center, 2-arm quasi-experimental study. The control group received usual care, while cosmetic care was added to the intervention group. The primary outcomes were BI and SAD accompanying chemotherapy, and the secondary outcome was the appearance satisfaction.

详细描述

Background: The diagnosis and treatment of breast cancer may still bring severe psychological trauma to women. Cosmetic care is an effective measure to enhance patients' psychosocial functioning, which can help cancer patients cope with disfigurement-related adverse effects.

Objectives: This study aimed to explore the effects of cosmetic care on body image (BI), and social avoidance and distress (SAD) in young Chinese breast cancer patients, aged 18-40 years old, receiving adjuvant chemotherapy.

Study design: This was a prospective, 2-arm quasi-experimental study, comprising two groups: the controlled group and the interventional group. In order to avoid interference, the two groups of participants were recruited at different periods. The control group was recruited from Jan 2015 to Mar 2015, and the intervention group was recruited from January 2016 to September 2017. All participants came from the department of a breast surgery in Shanghai, China.

Control condition: Participants in the control group received usual care during adjuvant chemotherapy.

Intervention: Participants in the intervention group received cosmetic care in combination with usual care.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
25 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Primary breast cancer patients
  • Aged 18-40 years old, who received surgery and adjuvant chemotherapy in our department
  • No prior neoadjuvant chemotherapy
  • Being available to communicate by the novel social application "Wechat"

排除标准

  • Diagnosis of psychiatric or intellectual impairment
  • Having a history of neoadjuvant therapy
  • Having distant metastasis

结局指标

主要结局

Social avoidance and distress scale

时间窗: Change from baseline to half of the cycle of chemotherapy and the end of cycle of chemotherapy (each cycle is 21 days, and there were 4-6 cycles totally.)

Social avoidance and distress (SAD) was assessed using social avoidance and distress scale, which contains 28 items. The total score in the scale ranges from 0 to 28. A higher score means greater SAD.

Body image scale

时间窗: Change from baseline to half of the cycle of chemotherapy and the end of cycle of chemotherapy (each cycle is 21 days, and there were 4-6 cycles totally).

Body image (BI) was assessed using the body image scale. It is a 10-item self-assessment scale, measuring cancer patients' perception of their appearance. The minimum and maximum values of the scale are 0 and 30. A higher score signifies a worse BI.

次要结局

  • Appearance satisfaction questionnaire(The end of cycle of chemotherapy (each cycle is 21 days, and there were 4-6 cycles totally.).)

研究者

发起方
Zhenqi Lu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zhenqi Lu

Director of nursing department in Fudan University Shanghai Cancer Center

Fudan University

研究点 (1)

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