A Randomized Controlled Trial of Psychosocial Interventions Facilitating Positive Psychological Adaptation in Patients With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- posttraumatic growth by the PTGI
研究概览
简要总结
To test the effects of a 10-wk stress management interventions vs. a 5-wk control condition on positive psychosocial adaptation in women being treated for breast cancer. Participants assigned to either of the stress management groups will show better positive psychosocial adaptation compared to those in the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged between 20 and 70 years
- •Newly diagnosed breast cancer patients in stages I, II, or III (with no prior history of cancer)
- •Literate, without significant cognitive impairments
- •Capable of writing and expressing themselves in Chinese
排除标准
- •Major psychiatric disorders (such as schizophrenia), personality disorders, and substance addiction (excluding smoking)
- •Currently participating in other breast cancer-related psychotherapy studies
结局指标
主要结局
posttraumatic growth by the PTGI
时间窗: Baseline (T1), post-intervention (T2), 6 months post-intervention (T3)
the PTGI a 21-item questionnaire each scored on a range of 0-5.
Distress by the HADS
时间窗: Baseline (T1), post-intervention (T2), 6 months post-intervention (T3)
The HADS is a 14-item scale, with seven items relating to anxiety and seven relating to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.
次要结局
- Perceived Stress Management Abilities(Baseline (T1), post-intervention (T2), 6 months post-intervention (T3))
- Quality of Life by the SF-36(Baseline (T1), post-intervention (T2), 6 months post-intervention (T3))
- Positive and Negative affect(Baseline (T1), post-intervention (T2), 6 months post-intervention (T3))
研究者
Chihtao Cheng
Director, Psychiatric department, KFSYSCC, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center