Helping the Mother With Breast Cancer Support Her Child
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 181
- 试验地点
- 2
- 主要终点
- Increased parenting skills and confidence by diagnosed mothers
研究概览
简要总结
This is a 6-state randomized controlled trial (RCT) that uses a behavioral intervention to enhance parenting skills for school age children when a mother is recently diagnosed with early stage breast cancer. Efficacy analyses will include measures of the child's and mother's psychosocial adjustment, including enhanced parenting quality and skills related to the cancer.
详细描述
This is a Phase 3 randomized clinical trial of recently diagnosed mothers with local or regional breast cancer and their school age child. After baseline measures are taken, mothers are randomized into either intervention and control group. Intervention participants are given 5, 1-hour at home educational counseling sessions by a specially trained nurse. Control participants are mailed an educational booklet whose content focuses on supportive parenting behaviors that are part of the face to face sessions given to the experimental group.
The theoretical framework for the study derives from Bandura's Social Cognitive Theory, a contextual model of parenting, and stress and coping theory. Efficacy is evaluated through standardized valid and reliable questionnaires of psychosocial functioning in the mother (affect, mood, self-efficacy) and psychosocial functioning in the child (cognitive-emotional functioning, including behavioral problems, anxiety, depressed mood, and cancer-related concerns). Primary study hypotheses will be evaluated comparing pre-posttest measures of the intervention compared to controls at post-test and 1-year follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Local or regional breast cancer recently diagnosed
- •Able to read and write English
- •Has one or more school age child(ren) living at home
- •Married to a man or in a committed long-term intimate relationship with a male partner
排除标准
- •Non-English speaking
- •Advanced stage breast cancer
- •Not recently diagnosed
- •Single mother
结局指标
主要结局
Increased parenting skills and confidence by diagnosed mothers
时间窗: 1-year
次要结局
- Decreased anxiety and depressed mood in diagnosed mothers(1 year)
研究者
Frances M. Lewis
Professor, Family and Child Nursing
University of Washington
