Maternal Problem-Solving in Childhood Cancer

Phase 3

Completed

• Conditions: Stress; Cancer

• Registration Number: NCT00234793
• Lead Sponsor: University of Rochester

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.

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 Timeline

• Study Start: 2003-05
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-10-05
• Study First Posted: 2005-10-07
• Study Completion: 2010-04
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-11
• Last Update Posted: 2015-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 433

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Standardized measures at three time points: pre-intervention, post-intervention, 3 months post the second time point

Trial Locations

Locations (4)

Oregon Health Sciences University; 🇺🇸 Portland, Oregon, United States

UT/MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Children's Hospital of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States