StressPhase 3NCT00234793
Maternal Problem-Solving in Childhood Cancer
A Phase 3 study testing Problem-Solving Skills Training in people with Stress and Cancer, run by University of Rochester at 4 sites in United States.
Trial 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 more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- What is being tested?
- Problem-Solving Skills Training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 433 participants
- Where
- 4 sitesUnited States
- Study dates
- May 2003to Apr 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Mothers of any age with a child diagnosed with any form of cancer 2-16 weeks prior to contact.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
UT/MD Anderson Cancer Center
Houston, Texas, 77030
Children's Hospital Los Angeles
Los Angeles, California, 90027-6016
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15214
Oregon Health Sciences University
Portland, Oregon, 97201
About this study
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:
- 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.
- Being tested
- Problem-Solving Skills Training
- Keywords
- childhood cancer, intervention, maternal coping, problem solving skills, anxiety, cope, problem solving
- Medical subject headings
- Neoplasms, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem-Solving Skills TrainingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (1)
Standardized measures at three time points: pre-intervention, post-intervention, 3 months post the second time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2005 (estimated)
- Study startMay 2003
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 433 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, OJ Sahler, University of Rochester
- Investigators
- Olle Jane Z. Sahler, MD, Principal investigator, University of RochesterRobert W Butler, PhD, Principal investigator, Oregon Health and Science UniversityMartha A Askins, PhD, Principal investigator, M.D. Anderson Cancer CenterRobert B Noll, PhD, Principal investigator, University of PittsburghErnest R Katz, PhD, Principal investigator, Children's Hospital Los AngelesDonna R Copeland, PhD, Principal investigator, UT/MD Anderson Cancer CenterLewis W Johnson, PhD, Study director, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00234793
- Sponsor's protocol ID
- RO1 CA098964-02
- Other IDs
- RSRB 09840
- Status last verified
- Jun 2015
- First submitted
- 12 Sep 2005
- Last updated
- 15 Jun 2015
- Results posted
- No
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 19091804Sahler 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Problem-Solving in Childhood Cancer
- ClinicalTrials.gov ID
- NCT00234793
- Acronym / sponsor ID
- RO1 CA098964-02
- Keywords
- childhood cancer, intervention, maternal coping, problem solving skills, anxiety, cope, problem solving
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 433 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- May 2003
- Study completion
- Apr 2010
- First posted
- 7 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Mothers of any age with a child diagnosed with any form of cancer 2-16 weeks prior to contact.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Problem-Solving Skills Training | Behavioural | – |
Primary outcome
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
1 secondary outcome
Standardized measures at three time points: pre-intervention, post-intervention, 3 months post the second time point
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2015.
- Results publication: PubMed 19091804Askins 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.
- Derived from this study: PubMed 23358975Sahler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Problem-Solving Skills Training in people with Stress and Cancer, run by University of Rochester at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00234793, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2015.