Enhancing Connections: Helping the Mother With Breast Cancer Support Her Child

Phase 3

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00194571
• Lead Sponsor: University of Washington

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 1999-06
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-19
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2008-01
• Last Update Submitted: 2016-05-19
• Last Update Posted: 2016-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 181

Inclusion Criteria

• 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

Read More

Exclusion Criteria

• Non-English speaking
• Advanced stage breast cancer
• Not recently diagnosed
• Single mother

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Increased parenting skills and confidence by diagnosed mothers	1-year

Secondary Outcome Measures

Name	Time	Method
Decreased anxiety and depressed mood in diagnosed mothers	1 year

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States