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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by University of Washington.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00194571
First received: September 13, 2005
Last updated: January 2, 2008
Last verified: January 2008
History of Changes
  Purpose

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 Intervention Phase
Breast Cancer
 Behavioral: Educational counseling intervention
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Helping the Mother With Breast Cancer Support Her Child

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Increased parenting skills and confidence by diagnosed mothers [ Time Frame: 1-year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Decreased anxiety and depressed mood in diagnosed mothers [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 181
Study Start Date: June 1999
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00194571

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

No publications provided

Responsible Party: Frances Marcus Lewis, University of Washington
ClinicalTrials.gov Identifier: NCT00194571     History of Changes
Other Study ID Numbers: 99-2050-C06, R01 CA 784244
Study First Received: September 13, 2005
Last Updated: January 2, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
breast cancer,
child functioning,
parenting,
 self-efficacy,
psychoeducational intervention
counseling

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

ClinicalTrials.gov processed this record on May 16, 2013