NCT00194571

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
181

participants targeted

Target at below P25 for phase_3 breast-cancer

Timeline
Completed

Started Jun 1999

Typical duration for phase_3 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1999

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

May 20, 2016

Status Verified

January 1, 2008

Enrollment Period

7.9 years

First QC Date

September 13, 2005

Last Update Submit

May 19, 2016

Conditions

Breast Cancer

Keywords

breast cancer,child functioning,parenting,self-efficacy,psychoeducational interventioncounseling

Outcome Measures

Primary Outcomes (1)

  • Increased parenting skills and confidence by diagnosed mothers

    1-year

Secondary Outcomes (1)

  • Decreased anxiety and depressed mood in diagnosed mothers

    1 year

Interventions

Educational counseling interventionBEHAVIORAL

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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Non-English speaking
  • Advanced stage breast cancer
  • Not recently diagnosed
  • Single mother

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (1)

  • Almulla HA, Lewis FM, Oxford ML. Development and Psychometric Evaluation of the Children's Illness-Related Concerns Scale. Nurs Res. 2023 Sep-Oct 01;72(5):E172-E179. doi: 10.1097/NNR.0000000000000670.

    PMID: 37625187DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Frances M Lewis, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Family and Child Nursing

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 19, 2005

Study Start

June 1, 1999

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

May 20, 2016

Record last verified: 2008-01

Locations

US(1)