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Completed

NCT Number: NCT00194571

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Washington

Seattle, Washington, 98195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational counseling intervention

Behavioral

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.

Primary outcomes

  1. Increased parenting skills and confidence by diagnosed mothers

    Time frame: 1-year

Secondary outcomes

  1. Decreased anxiety and depressed mood in diagnosed mothers

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Helping the Mother With Breast Cancer Support Her Child

Acronym: EC R01

Important dates

Study start
1999
Primary completion
2007
Study completion
2007
First posted
Sep 19, 2005
Registry last updated
May 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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