NCT00234793

Brief Summary

The purpose of this study is to help mothers of children with cancer to cope more effectively by increasing their problem-solving skills.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
433

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2003

Longer than P75 for phase_3

Geographic Reach
1 country

4 active sites

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

May 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
25 days until next milestone

First Posted

Study publicly available on registry

October 7, 2005

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

June 15, 2015

Status Verified

June 1, 2015

First QC Date

September 12, 2005

Last Update Submit

June 11, 2015

Conditions

Keywords

childhood cancerinterventionmaternal copingproblem solving skillsanxietycopeproblem solving

Outcome Measures

Primary Outcomes (2)

  • The primary aim of the study is to evaluate the effectiveness of problem-solving training provided to mothers of children with newly diagnosed cancer in decreasing negative affectivity

  • e.g. depression, anxiety, and increasing satisfaction with resource utilization

Secondary Outcomes (1)

  • Standardized measures at three time points: pre-intervention, post-intervention, 3 months post the second time point

Interventions

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Mothers of any age with a child diagnosed with any form of cancer 2-16 weeks prior to contact.

You may not qualify if:

  • Mothers of children with cancer if they do not read or speak English or Spanish, if their child is in severe medical crisis, or if they live a prohibitive distance to complete the intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Children's Hospital Los Angeles

Los Angeles, California, 90027-6016, United States

Location

Oregon Health Sciences University

Portland, Oregon, 97201, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15214, United States

Location

UT/MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (2)

  • Askins MA, Sahler OJ, Sherman SA, Fairclough DL, Butler RW, Katz ER, Dolgin MJ, Varni JW, Noll RB, Phipps S. Report from a multi-institutional randomized clinical trial examining computer-assisted problem-solving skills training for English- and Spanish-speaking mothers of children with newly diagnosed cancer. J Pediatr Psychol. 2009 Jun;34(5):551-63. doi: 10.1093/jpepsy/jsn124. Epub 2008 Dec 17.

  • Sahler OJ, Dolgin MJ, Phipps S, Fairclough DL, Askins MA, Katz ER, Noll RB, Butler RW. Specificity of problem-solving skills training in mothers of children newly diagnosed with cancer: results of a multisite randomized clinical trial. J Clin Oncol. 2013 Apr 1;31(10):1329-35. doi: 10.1200/JCO.2011.39.1870. Epub 2013 Jan 28.

MeSH Terms

Conditions

NeoplasmsAnxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Olle Jane Z. Sahler, MD

    University of Rochester

    PRINCIPAL INVESTIGATOR
  • Robert W Butler, PhD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR
  • Martha A Askins, PhD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR
  • Robert B Noll, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR
  • Ernest R Katz, PhD

    Children's Hospital Los Angeles

    PRINCIPAL INVESTIGATOR
  • Donna R Copeland, PhD

    UT/MD Anderson Cancer Center

    PRINCIPAL INVESTIGATOR
  • Lewis W Johnson, PhD

    University of Southern California

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 12, 2005

First Posted

October 7, 2005

Study Start

May 1, 2003

Study Completion

April 1, 2010

Last Updated

June 15, 2015

Record last verified: 2015-06

Locations