Breast Cancer
Conditions
Keywords
breast cancer,, child functioning,, parenting,, self-efficacy,, psychoeducational intervention, counseling
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.
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.
Interventions
BEHAVIORALEducational 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.
Sponsors
National Cancer Institute (NCI)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increased parenting skills and confidence by diagnosed mothers | 1-year |
Secondary
| Measure | Time frame |
|---|---|
| Decreased anxiety and depressed mood in diagnosed mothers | 1 year |
Countries
United States
Outcome results
None listed