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

University of Washington

Status and phase

Completed

Phase 3

Conditions

Breast Cancer

Treatments

Behavioral: Educational counseling intervention

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00194571

16636-C

1R01CA078424-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

181 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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