We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Enhancing Connections: Helping the Mother With Breast Cancer Support Her Child (EC R01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00194571
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : May 20, 2016
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: Educational counseling intervention Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 181 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Helping the Mother With Breast Cancer Support Her Child
Study Start Date : June 1999
Primary Completion Date : May 2007
Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    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.

Outcome Measures

Primary Outcome Measures :
  1. Increased parenting skills and confidence by diagnosed mothers [ Time Frame: 1-year ]

Secondary Outcome Measures :
  1. Decreased anxiety and depressed mood in diagnosed mothers [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00194571

United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Principal Investigator: Frances M Lewis, PhD University of Washington
More Information

Responsible Party: Frances M. Lewis, Professor, Family and Child Nursing, University of Washington
ClinicalTrials.gov Identifier: NCT00194571     History of Changes
Other Study ID Numbers: 16636-C
1R01CA078424-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: May 20, 2016
Last Verified: January 2008

Keywords provided by Frances M. Lewis, University of Washington:
breast cancer,
child functioning,
psychoeducational intervention

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases