Expressive Writing Among Chinese Breast Cancer Survivors: Study One
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 4
- 主要终点
- Change in quality of life score as assessed by Functional Assessment of Cancer Therapy Scale (FACT).
研究概览
简要总结
This study is a randomized controlled trial (RCT) with the aim of determining the cultural sensitivity, feasibility, and effectiveness of an expressive writing intervention for Chinese breast cancer survivors.
详细描述
The study examines the potential health benefits (i.e., physical health, psychological health, and quality of life) of this expressive writing intervention for Chinese-speaking breast cancer survivors. The study also explores the mechanism through which expressive writing confers health benefits and investigates who will benefit most from the expressive writing intervention. Chinese-speaking breast cancer survivors who have completed primary treatment will be randomly assigned to a control writing condition, a self-regulation condition, or an emotional disclosure writing condition. Health outcomes are assessed at baseline, and 1, 3, and 6 months follow-ups. Mixed qualitative-quantitative mixed methods are used to explore the effect of the intervention on health outcomes and explore the mechanisms that explain the benefits of this intervention.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •having a breast cancer diagnosis
- •completing primary medical treatment within four years
- •being comfortable writing and speaking Chinese (i.e. Mandarin or Cantonese)
排除标准
- 未提供
研究组 & 干预措施
Control Condition
Participants in the control group were asked to write for three weeks about facts regarding their cancer and its treatment for three sessions.
Self-regulation Condition
For the self-regulation condition, each weekly writing assignment covers a different task. During session one, participants will be asked to write about their deepest feelings and thoughts regarding their experience with breast cancer as well as its impact on their lives; in session two, participants will be asked to write about their coping strategies to deal with stressors associated with the cancer diagnosis and treatment, as well as future plans for coping with cancer-related stressors; and in session three, participants will be asked to write about positive thoughts and feelings regarding their experience with breast cancer.
干预措施: Self-Regulation Condition (Behavioral)
Emotional Disclosure condition
For the emotional disclosure condition, participants were asked to write about their deepest thoughts and feelings about their cancer experience for three weeks.
干预措施: Emotional Disclosure Condition (Behavioral)
结局指标
主要结局
Change in quality of life score as assessed by Functional Assessment of Cancer Therapy Scale (FACT).
时间窗: Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
The Functional Assessment of Cancer Therapy Scale (FACT) is a 27-item measure of health-related quality of life (Cella \& Tulsky,1993), which assesses perceived life quality in four different facets, including physical well-being (7 items), social well-being (7 items), emotional well-being (6 items), and functional wellbeing (7 items).
次要结局
- Change in perceived pain assessed by Brief Pain Inventory short form.(Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.)
- Change in Post-traumatic stress symptoms assessed by The PTSD Symptom Scale - Self Report(Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.)
- Change in fatigue as assessed by Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F)(Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.)
- Change in sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI)(Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.)
- Change in physical symptoms as assessed by the Physical Symptoms Checklist(Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.)
研究者
Qian Lu
Associate Professor
University of Houston