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Helping the Mother With Breast Cancer Support Her Child
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.
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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
University of Washington
Seattle, Washington, United States
Start Date
June 1, 1999
Primary Completion Date
May 1, 2007
Completion Date
May 1, 2007
Last Updated
May 20, 2016
181
ESTIMATED participants
Educational counseling intervention
BEHAVIORAL
Lead Sponsor
University of Washington
Collaborators
NCT04550494
NCT04704661
Data Source & Attribution
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