CClinicalTrials.gg
CompletedNCT00234793Updated Jun 15, 2015

Maternal Problem-Solving in Childhood Cancer

A Phase 3 interventional study of Problem-Solving Skills Training in Stress and Cancer, sponsored by University of Rochester. Completed at 4 sites in United States. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-06-15.

Sponsored by University of Rochester · Phase 3 and Interventional

Phase
Phase 3
Study type
Interventional
Enrollment
433
Allocation
Randomized
Sex
Female
01

Study summary

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

Read the 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.
02

Conditions studied

  • Stress
  • Cancer

Keywords

  • childhood cancer
  • intervention
  • maternal coping
  • problem solving skills
  • anxiety
  • cope
  • problem solving
03

In context

Lead sponsor

University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

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.
05

Study design

Phase
Phase 3
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
433 participants (actual)

Interventions

  • BehavioralProblem-Solving Skills Training
06

What researchers measure

Primary outcomes

  1. 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

  2. e.g. depression, anxiety, and increasing satisfaction with resource utilization

Secondary outcomes

  1. Standardized measures at three time points: pre-intervention, post-intervention, 3 months post the second time point

07

Study locations

4 sites
  • Children's Hospital Los Angeles
    Los Angeles, California 90027-6016, United States
  • Oregon Health Sciences University
    Portland, Oregon 97201, United States
  • Children's Hospital of Pittsburgh
    Pittsburgh, Pennsylvania 15214, United States
  • UT/MD Anderson Cancer Center
    Houston, Texas 77030, United States
08

References and documents

Publications

  • 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. PubMed 19091804 ↗
  • 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. PubMed 23358975 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00234793
Lead sponsor
University of Rochester
Collaborators
National Institutes of Health (NIH)
Responsible party
OJ Sahler (Professor, University of Rochester) — Principal investigator
First posted
Oct 7, 2005
Start date
May 2003
Completion
Apr 2010
Last update
Jun 15, 2015

Study contacts

Olle Jane Z. Sahler, MD
principal investigator · University of Rochester
Robert W Butler, PhD
principal investigator · Oregon Health and Science University
Martha A Askins, PhD
principal investigator · M.D. Anderson Cancer Center
Robert B Noll, PhD
principal investigator · University of Pittsburgh
Ernest R Katz, PhD
principal investigator · Children's Hospital Los Angeles
Donna R Copeland, PhD
principal investigator · UT/MD Anderson Cancer Center
Lewis W Johnson, PhD
study director · University of Southern California
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion