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

Breast Cancer Clinical Trial

— EC R01  

Official title:

Helping the Mother With Breast Cancer Support Her Child

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00194571
• Other study ID #: 16636-C
• Secondary ID: 1R01CA078424-01A
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: May 19, 2016
• Start date: June 1999
• Est. completion date: May 2007

Study information

• Verified date: January 2008
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Exclusion Criteria:

• Non-English speaking

• Advanced stage breast cancer

• Not recently diagnosed

• Single mother

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Educational counseling intervention
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.

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increased parenting skills and confidence by diagnosed mothers		1-year	No
Secondary	Decreased anxiety and depressed mood in diagnosed mothers		1 year	No