A Phase 3 interventional study of Educational counseling intervention in Breast Cancer, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-05-20.
Sponsored by University of Washington · Phase 3, Interventional, and Treatment
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 181 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This intervention involves 5 face to face educational counseling sessions with a specially trained patient educator; sessions are fully manualized and complemented by handouts given to the diagnosed parent.
Increased parenting skills and confidence by diagnosed mothers
Time frame: 1-year
Decreased anxiety and depressed mood in diagnosed mothers
Time frame: 1 year
This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.
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University of Washington