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Maternal Problem-Solving in Childhood Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00234793
Recruitment Status : Completed
First Posted : October 7, 2005
Last Update Posted : June 15, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Stress Cancer Behavioral: Problem-Solving Skills Training Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 433 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Maternal Problem-Solving in Childhood Cancer
Study Start Date : May 2003
Estimated Study Completion Date : April 2010
Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. 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
  2. e.g. depression, anxiety, and increasing satisfaction with resource utilization

Secondary Outcome Measures :
  1. Standardized measures at three time points: pre-intervention, post-intervention, 3 months post the second time point

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Institutes of Health (NIH)
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 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