Maternal Problem-Solving in Childhood Cancer

Sponsor

University of Rochester (Other)

Overall Status

Completed

CT.gov ID

NCT00234793

Collaborator

National Institutes of Health (NIH) (NIH)

433

Enrollment

Locations

Duration (Months)

108.3

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

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:

to develop a time-and-attention control condition to better assess the direct and mediational effect of PSST independent of social support (placebo);
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;
to develop independent measures of the application of problem-solving strategies in everyday life; and
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

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 1, 2003

Study Completion Date :

Apr 1, 2010

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital Los Angeles	Los Angeles	California	United States	90027-6016
2	Oregon Health Sciences University	Portland	Oregon	United States	97201
3	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania	United States	15214
4	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