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Helping the Mother With Breast Cancer Support Her Child


Phase 3
18 Years
65 Years
Open (Enrolling)
Both
Breast Cancer

Thank you

Trial Information

Helping the Mother With Breast Cancer Support Her Child


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Increased parenting skills and confidence by diagnosed mothers

Outcome Time Frame:

1-year

Safety Issue:

No

Principal Investigator

Frances M Lewis, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Washington

Authority:

United States: Institutional Review Board

Study ID:

99-2050-C06

NCT ID:

NCT00194571

Start Date:

June 1999

Completion Date:

May 2009

Related Keywords:

  • Breast Cancer
  • breast cancer,
  • child functioning,
  • parenting,
  • self-efficacy,
  • psychoeducational intervention
  • counseling
  • Breast Neoplasms

Name

Location
University of Washington Seattle, Washington  98195