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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014