Maternal Problem-Solving in Childhood Cancer

NCT ID: NCT00234793

Last Updated: 2015-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

433 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2010-04-30

Brief Summary

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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

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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.

Conditions

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Stress Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Interventions

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Problem-Solving Skills Training

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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OJ Sahler

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Olle Jane Z. Sahler, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Robert W Butler, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Martha A Askins, PhD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Robert B Noll, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Ernest R Katz, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Los Angeles

Donna R Copeland, PhD

Role: PRINCIPAL_INVESTIGATOR

UT/MD Anderson Cancer Center

Lewis W Johnson, PhD

Role: STUDY_DIRECTOR

University of Southern California

Locations

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Children's Hospital Los Angeles

Los Angeles, California, United States

Site Status

Oregon Health Sciences University

Portland, Oregon, United States

Site Status

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

UT/MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

References

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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-speaking mothers of children with newly diagnosed cancer. J Pediatr Psychol. 2009 Jun;34(5):551-63. doi: 10.1093/jpepsy/jsn124. Epub 2008 Dec 17.

Reference Type RESULT
PMID: 19091804 (View on PubMed)

Sahler OJ, Dolgin MJ, Phipps S, Fairclough DL, Askins MA, Katz ER, Noll RB, Butler RW. Specificity of problem-solving skills training in mothers of children newly diagnosed with cancer: results of a multisite randomized clinical trial. J Clin Oncol. 2013 Apr 1;31(10):1329-35. doi: 10.1200/JCO.2011.39.1870. Epub 2013 Jan 28.

Reference Type DERIVED
PMID: 23358975 (View on PubMed)

Other Identifiers

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RSRB 09840

Identifier Type: -

Identifier Source: secondary_id

RO1 CA098964-02

Identifier Type: -

Identifier Source: org_study_id

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