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临床试验/NCT02593422
NCT02593422已完成不适用

Writing About Experiences With Ovarian Cancer

University of Maryland, College Park1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2015年4月1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
73
试验地点
1
主要终点
Change in Psychological Functioning (Wellbeing/Distress)

研究概览

简要总结

This online study aims to understand whether writing about one's experiences with ovarian cancer may be beneficial for psychological and physical wellbeing in women with a history of ovarian cancer. Investigators are also interested in studying how certain individual characteristics may impact the effectiveness of writing. Participants will be asked to complete an initial survey (15 min), followed by writing about their experiences with ovarian cancer on four occasions (20 - 25 min each), over the course of two weeks. A final survey (10 min) will be completed one month afterwards.

详细描述

The purpose of this randomized controlled experiment is to examine the effects of writing about experiences with ovarian cancer on psychological and physical outcomes in English-speaking women with a history of ovarian cancer. It will also examine how certain individual characteristics may impact the effectiveness of the writing interventions for different women. After completing an initial survey, women will be asked to write about their experiences with ovarian cancer on 4 separate occasions of 20-25 min each in the course of 2 weeks. A final survey will be completed one month after the last writing session. The entire study will be conducted online.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

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

  • •Women with a history of ovarian cancer (any stage)
  • •At least 18 years old
  • •English-speaking/Can comfortably read and write in English
  • •Able to provide informed consent
  • •Internet access
  • •Valid email address
  • •Any region/country

排除标准

  • •Minors (younger than 18)
  • •Lack of English proficiency
  • •Inability to provide informed consent

研究组 & 干预措施

Expressive Writing

Experimental

Writing about ovarian cancer: Participants will be asked to write about their deepest thoughts and emotions about their experience with ovarian cancer

干预措施: Expressive Writing (Behavioral)

Fact Writing (Control)

Active Comparator

Writing about ovarian cancer: Participants will be asked to write about the facts of their experience with ovarian cancer

干预措施: Fact Writing (Control) (Behavioral)

结局指标

主要结局

Change in Psychological Functioning (Wellbeing/Distress)

时间窗: 6 - 9 weeks, with timely completion of writing: Initial survey (day 1), after 2nd writing task (week 1), after 4th writing task (week 2), and one month after last writing task (week 6)

Various aspects of social, emotional and functional wellbeing will be assessed using the Functional Assessment of Cancer-Ovarian measure (FACT-O, Version 4, Basen-Engquist et al, 2001). Distress about ovarian cancer will be assessed using the Impact of Event Scale (IES, Horowitz, Wilner \& Alvarez, 1979).

次要结局

  • Change in Physical Wellbeing(6 - 9 weeks, with timely completion of writing: Initial survey (day 1), after 2nd writing task (week 1), after 4th writing task (week 2), and one month after last writing task (week 6))
  • Changes in affect before and after writing about ovarian cancer(Prior to and after each of 4 writing tasks (weeks 1 - 2))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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