Clinical trial NCT00234793: Maternal Problem-Solving in Childhood Cancer
Official title: Maternal Problem-Solving in Childhood Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stress
Cancer
Keywords: childhood cancer
intervention
maternal coping
problem solving skills
anxiety
cope
problem solving
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2005-10-07
Enrollment: 433
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
measure: e.g. depression, anxiety, and increasing satisfaction with resource utilization
Secondary outcomes:
measure: Standardized measures at three time points: pre-intervention, post-intervention, 3 months post the second time point
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
city: Houston
country: United States
facility: UT/MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: University of Rochester
name: Olle Jane Z. Sahler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University
name: Robert W Butler, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: M.D. Anderson Cancer Center
name: Martha A Askins, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Robert B Noll, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Los Angeles
name: Ernest R Katz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UT/MD Anderson Cancer Center
name: Donna R Copeland, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern California
name: Lewis W Johnson, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.