A Culturally Sensitive Social Support Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Change in Quality of life 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) to assess the impact of a culturally based social support program (i.e. Joy Luck Academy, JLA) among Chinese American breast cancer survivors.
详细描述
This study is a randomized controlled trial (RCT) to test the health benefits of an education and peer mentor support intervention. Chinese American breast cancer survivors who have completed primary treatment will be randomly assigned to either the intervention group or a control group to receive enhanced usual care while waiting for the JLA. Health outcomes are assessed at baseline, immediately post intervention, and 1 and 4 months follow-ups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (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
- •self-identified to be comfortable speaking Chinese (Mandarin or Cantonese)
- •having a first breast cancer diagnosis of stages 0-III
- •having completed primary treatment (surgery, chemotherapy, or radiotherapy) within the last 36 months
排除标准
- •unable to read or speak Chinese (Mandarin or Cantonese)
- •breast cancer diagnosis of stage IV
- •live outside of the LA area
研究组 & 干预措施
Enhanced care and wait-list control group
Participants in the control group will receive enhanced usual care while waiting for the JLA program. Participants will be given information booklets in Chinese developed by the American Cancer Society and cover common issues related to breast cancer, various treatments, and life after treatment. Participants will be asked to read through the booklet individually.
Social support intervention group
The intervention is a 7-week program includes educational and peer mentoring support components. The education curriculum provides information on recognizing side effects of treatment and differentiating them from symptoms of cancer recurrence, physical therapy and alternative treatment, stress management, recognizing depression and managing emotional problems, communication with family members, and body image. The peer-support component assigns each participant with a mentor who is a breast cancer survivor. They share their own experience with participants and also make weekly phone calls to mentees during the intervention to provide support and address remaining concerns.
干预措施: Social support intervention (Behavioral)
结局指标
主要结局
Change in Quality of life as assessed by Functional Assessment of Cancer Therapy Scale (FACT)
时间窗: Baseline before intervention and immediately, 1 month, and 4 months after the intervention
次要结局
- Change in positive affect as assessed by the PANAS(Baseline before intervention and immediately, 1 month, and 4 months after the intervention)
- Change in fatigue as assessed by FACIT(Baseline before intervention and immediately, 1 month, and 4 months after the intervention)
- Change in stress as assessed by the Perceived stress scale (PSS)(Baseline before intervention and immediately, 1 month, and 4 months after the intervention)
- Change in depressive symptoms as assessed by CES-D(Baseline before intervention and immediately, 1 month, and 4 months after the intervention)