Maternal Problem-Solving in Childhood Cancer
2 other identifiers
interventional
433
1 country
4
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2003
Longer than P75 for phase_3
4 active sites
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
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
October 7, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedJune 15, 2015
June 1, 2015
September 12, 2005
June 11, 2015
Conditions
Keywords
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
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
- University of Rochesterlead
- National Institutes of Health (NIH)collaborator
Study Sites (4)
Children's Hospital Los Angeles
Los Angeles, California, 90027-6016, United States
Oregon Health Sciences University
Portland, Oregon, 97201, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15214, United States
UT/MD Anderson Cancer Center
Houston, Texas, 77030, United States
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.
PMID: 19091804RESULTSahler 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.
PMID: 23358975DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
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
- STUDY DIRECTOR
Lewis W Johnson, PhD
University of Southern California
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