Reducing Psychological Burdens Among Chinese Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 4
- 主要终点
- Change in quality of life score as assessed by the 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 a enhanced self-regulation 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; 2) completing breast cancer surgery within five years; and 3) 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)
Enhanced self-regulation condition
For the enhanced self-regulation condition, each weekly writing assignment covers a different task. During session one, 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; during session two, 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; 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: Enhanced self-Regulation Condition (Behavioral)
结局指标
主要结局
Change in quality of life score as assessed by the 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,score range 0 - 28), social well-being (7 items, score range 0 - 28), emotional well-being (6 items, score range 0-24), and functional well-being (7 items, score range 0-28). A higher subscale score indicates better functioning in the corresponding domain. Total score is computed by summing up the scores of the four subscales. Total score ranges from 0 to 108. A higher score indicates better quality of life.
次要结局
- 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 depressive symptoms as assessed by Center for Epidemiologic Studies Depression Scale (CES-D).(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.)
- Change in anxiety as assessed by Brief Symptom Inventory (BSI)-anxiety dimension(Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.)
- Change in posttraumatic stress disorder (PTSD), as assessed by the PTSD Symptom Scale - Self Report version (PSS-SR)(Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.)
研究者
Qian Lu
Associate Professor
University of Houston