Helping the Mother With Breast Cancer Support Her Child
18 Years
65 Years
Both
Breast Cancer
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 |
