Maternal Problem-Solving in Childhood Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00234793
First received: September 12, 2005
Last updated: September 30, 2010
Last verified: October 2005
  Purpose

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


Condition Intervention Phase
Stress
Cancer
Behavioral: Problem-Solving Skills Training
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Maternal Problem-Solving in Childhood Cancer

Resource links provided by NLM:


Further study details as provided by University of Rochester:

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

Enrollment: 433
Study Start Date: May 2003
Estimated Study Completion Date: April 2010
Detailed Description:

The purpose of this study is:

  1. to develop a time-and-attention control condition to better assess the direct and mediational effect of PSST independent of social support (placebo);
  2. to develop a personal digital assistant hand-held supplement to standard PSST to provide real-time training, reinforcement, and on-the-spot documentation of PSST usage;
  3. to develop independent measures of the application of problem-solving strategies in everyday life; and
  4. to measure utilization of and satisfaction with other resources accessed by mothers as independent indicators of the usefulness and cost-effectiveness of PSST.
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00234793

Locations
United States, California
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027-6016
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97201
United States, Pennsylvania
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15214
United States, Texas
UT/MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
University of Rochester
Investigators
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 Children's Hospital 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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00234793     History of Changes
Other Study ID Numbers: RO1 CA098964-02, RSRB 09840
Study First Received: September 12, 2005
Last Updated: September 30, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
childhood cancer
intervention
maternal coping
problem solving skills
anxiety
cope
problem solving

ClinicalTrials.gov processed this record on April 15, 2014