MDACC Study Summary 2003-0543

Study Summary
No. 2003-0543:.......Pediatrics......Martha Askins......Pediatrics

Study Summary Title



Study Summary Number:	2003-0543

Study Title:	Maternal Problem-Solving Skills Training with Comparison Groups

Physician

New Patient Referral



Name:	Martha Askins	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Pediatrics	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-794-4467 Contact us about clinical trials

General Information



Disease Group:	Pediatrics	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Once a week for 8 weeks. Visits to coincide with child's medical visits.

Treatment Agents:	None	Home Care:	None; unless family cannot come to M. D. Anderson.

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	Not Applicable


Description/ Intervention:	The goal of this research study is to see whether specialized education materials can be helpful to mothers of children with cancer in understanding and coping with the challenges they face at the hospital, at home, and/or with family.

Study Objectives / Outcomes

Our previous research has shown that Problem Solving Skills Training (PSST) is useful to mothers of children newly diagnosed with cancer in improving their problem-solving skills primarily, and secondarily to reduce distress associated with the illness. Briefly, our objectives are:
1: To develop a time-and-attention control condition to better assess the direct and mediational effects 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.
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 Status Information



Study Activation / Registration Date:	01/08/2004

IRB Review and Approval Date:	08/06/2003

Study Type:	Not Applicable

Recruitment Status:	Closed

Projected Accrual:	750 (all sites)

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Mothers of children diagnosed with cancer 2-16 weeks prior to our contact.

Exclusion Criteria:

1) Mothers who do not read or speak English or Spanish. 2) The child is in severe medical crisis. 3) The family lives greater than 50 miles from Cancer Center and will not be on-site frequently enough for the training sessions to take place.

Links

Registration Number: NCT00234793
Study Information on Clinical Trials Registry (clinicaltrials.gov)