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临床试验/NCT00194571
NCT00194571已完成3 期

Helping the Mother With Breast Cancer Support Her Child

University of Washington2 个研究点 分布在 1 个国家目标入组 181 人开始时间: 1999年6月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Frances M. Lewis

Professor, Family and Child Nursing

University of Washington

研究点 (2)

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