Maternal Problem-Solving in Childhood Cancer

June 11, 2015 updated by: OJ Sahler, University of Rochester
The purpose of this study is to help mothers of children with cancer to cope more effectively by increasing their problem-solving skills.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

433

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90027-6016
        • Children's Hospital Los Angeles
    • Oregon
      • Portland, Oregon, United States, 97201
        • Oregon Health Sciences University
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15214
        • Children's Hospital of Pittsburgh
    • Texas
      • Houston, Texas, United States, 77030
        • UT/MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Study Completion

April 1, 2010

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

October 5, 2005

First Posted (Estimate)

October 7, 2005

Study Record Updates

Last Update Posted (Estimate)

June 15, 2015

Last Update Submitted That Met QC Criteria

June 11, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RO1 CA098964-02
  • RSRB 09840

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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