Maternal Problem-Solving in Childhood Cancer

Cancer Clinical Trial

Official title:

Maternal Problem-Solving in Childhood Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00234793
• Other study ID #: RO1 CA098964-02
• Secondary ID: RSRB 09840
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: June 11, 2015
• Start date: May 2003
• Est. completion date: April 2010

Study information

• Verified date: June 2015
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 433
• Est. completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cancer
• Stress

Intervention

Behavioral:
• Problem-Solving Skills Training

Locations

Country	Name	City	State
United States	UT/MD Anderson Cancer Center	Houston	Texas
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	Oregon Health Sciences University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Askins MA, Sahler OJ, Sherman SA, Fairclough DL, Butler RW, Katz ER, Dolgin MJ, Varni JW, Noll RB, Phipps S. Report from a multi-institutional randomized clinical trial examining computer-assisted problem-solving skills training for English- and Spanish-s — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	e.g. depression, anxiety, and increasing satisfaction with resource utilization
Secondary	Standardized measures at three time points: pre-intervention, post-intervention, 3 months post the second time point