Childhood CancerNCT01711944
Online Problem Solving Skills Training
A study testing Problem-Solving Skills Training in people with Childhood Cancer, run by University of Rochester at 6 sites in United States.
Trial summary
Parents of children newly diagnosed with cancer experience depression and anxiety, especially in the first several months of treatment. Bright IDEAS, an 8-session problem-solving skills training (PSST) program has been used in studies with more than 900 mothers including more than 125 monolingual Spanish-speaking… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Childhood Cancer
- What is being tested?
- Problem-Solving Skills Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 629 participants
- Where
- 6 sitesUnited States
- Study dates
- Jul 2012to 30 Apr 2019
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: Subjects will be drawn from the pool of all parents who are primary caregivers of children diagnosed with any form of cancer 4-16 weeks prior to contact about the Problem Solving Skills Training intervention and cared for at one of the 4 data collection sites. No attempt will be made to stratify the sample by any particular demographic variables (e.g., age, ethnic background, or type of cancer diagnosed in their child), except that monolingual Spanish-speaking parents will be specifically recruited to provide adequate representation for statistical analysis at Childrens Hospital Los Angeles and UT/MD Anderson Cancer Center. Goal: 20% total enrollment.
Exclusion Criteria: Parents of children with cancer will be excluded if (1) they do not read or speak English or Spanish; (2) their child is in severe a medical crisis, as determined by the oncologist, or (3) they live a prohibitive distance to complete the intervention (typically, >50 miles from the Center) and do not have access to a telephone for phone intervention sessions. Internet access will be facilitated as part of the e-PSST intervention arm. These exclusionary criteria are identical to our previous work; <10% of eligible mothers have been excluded.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Texas Children's Hospital
Houston, Texas, 77030
University of Texas/MD Anderson Cancer Center
Houston, Texas, 77030
Children's Hospital Los Angeles
Los Angeles, California, 90027-6016
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105-3678
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Online Implementation of Problem Solving Skills Training for Mothers of Newly Diagnosed Childhood Cancer Patients
Parents of children newly diagnosed with cancer experience depression and anxiety, especially in the first several months of treatment. Bright IDEAS, an 8-session problem-solving skills training (PSST) program has been used in studies with more than 900 mothers including more than 125 monolingual Spanish-speaking mothers. It has been shown to significantly decrease mothers' distress and to particularly benefit Latina immigrants. This past spring, the NCI/NIH designated Bright IDEAS as a Research-Tested Intervention Program and has included it in the National Registry of Evidence-based Programs and Practices. To date, Bright IDEAS has been available to mothers at only a few cancer centers with specially trained personnel. This proposal is designed to bring Bright IDEAS on-line to make it available to mothers and fathers 24/7 anywhere with Internet access. The investigators will carefully analyze acceptability and use to gain insight into the most promising ways of disseminating interventions like Bright IDEAS using Internet, Internet II, and other emerging technologies.
Read the detailed description
Research and experience document that caregivers of children with cancer encounter extraordinary stresses during the child's illness. These stresses are particularly severe during diagnosis and early therapy and can interfere significantly with a caregiver's ability to make reasoned and timely decisions on their child's behalf. With increasing survivor rates, it has become evident that decisions made in the early stages of cancer management can have profound long-term effects, adding to the distress caregivers feel trying to make the "right" decisions. Too help mothers of newly diagnosed children cope more effectively with these challenges, the investigators conducted randomized controlled trials (R25CA65520, R01CA098954) to develop, field test, and evaluate the efficacy of the Bright IDEAS paradigm of problem-solving skills training (PSST), a cognitive-behavioral therapy shown to decrease anxiety and depression - two symptoms of post-traumatic stress commonly experienced among this group of mothers. Our findings clearly show that PSST significantly increases problem-solving skills (primary effect) and decreases negative affectivity (secondary effect) in mothers from a variety of racial, ethnic, and socioeconomic backgrounds. Particularly powerful and long-lasting effects were noted in Spanish-speaking mothers, an especially underserved population. In March 2010, the NCI designated Bright IDEAS as a Research-based Therapy/Intervention Program (RTIP) and entered it into the National Registry of Evidence-based Programs and Practices (NREPP). As an 8-session, in-person intervention, Bright IDEAS is labor intensive and, to date, has only been available at a few institutions with trained personnel. However, as a part of the RTIPs evaluation process, the Dissemination Capability of Bright IDEAS was rated 5/5. This proposal is designed to meet the challenge inherent in this perfect score. The investigators will also immediately broaden the scope of users by including fathers as eligible participants in this study of a new delivery paradigm the investigators believe they will find appealing. Aim 1 is implementation of an engaging, easy-to-use on-line version of Bright IDEAS that would be available 24/7 to any person anywhere who has access to the Internet. Aim 2 is the use of "Diffusion of Innovations" theory to craft a framework for disseminating not only Bright IDEAS but other similar interventions with the greatest effectiveness and efficiency. In past studies, the investigators have shown that the human element (time and attention) inherent in in-person interventions is effective in bringing immediate relief of distress but not sufficient to maintain its benefits over time. In contrast, mothers receiving PSST increase their skills and continue to improve their sense of well-being 3 months after the intervention. What the investigators have not investigated is whether a computer-based intervention is as effective as (not inferior to) an in-person intervention. The results will have significant implications for future dissemination strategies, especially the use of Internet II and other emerging technologies.
- Conditions
- Childhood Cancer
- Being tested
- Problem-Solving Skills Training
- Keywords
- childhood cancer, Internet communication, parents, caregivers, problem solving
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem-Solving Skills TrainingBehavioural
Also called PSST, Bright IDEAS, Online PSST, Standard or face-to-face PSST
8-session manualized intervention to provide problem-solving skills training in the context of childhood cancer.
| Study group | Role | What they receive |
|---|---|---|
| Online PSST | Experimental | An online version of Problem-Solving Skills Training (PSST) will be compared to standard (face-to-face) PSST Receives: Behavioral: Problem-Solving Skills Training |
| Face-to-Face PSST | Active comparator | This is an 8-session face-to-face Problem-Solving Skills Training intervention Receives: Behavioral: Problem-Solving Skills Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Problem Solving Skills Inventory
This is a well validated assessment of problem-solving strategies and positive or negative orientation to problem solving.
Measured: Baseline (T1), post intervention (3 months; T2), 3 months post intervention (6 months; T3)
Secondary outcomes (2)
Profile of Mood States
This is a well validated measure of depression and anxiety
Measured: Baseline (T1); post intervention (3 months; T2); 3 months post intervention (6 months; T3)
Patient Health Questionnaire (PHQ9)
A 9-item self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ9 is the depression module which rates each of the nine DSM-IV criteria as 0 (not at all) to 3 (nearly every day). It will be used in place of the Beck Depression Inventory.
Measured: Baseline (T1), post intervention (3 months; T2), 3 months post intervention (6 months; T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2012 (estimated)
- Study startJul 2012
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood CancerStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 629 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- M.D. Anderson Cancer Center, University of Texas, El Paso, University of Colorado, Denver, University of Pittsburgh, Rutgers Cancer Institute of New Jersey, Children's Hospital Los Angeles, St. Jude Children's Research Hospital, National Institutes of Health (NIH)
- Responsible party
- Principal investigator, OJ Sahler, University of Rochester
- Investigators
- Olle Jane Z Sahler, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01711944
- Sponsor's protocol ID
- 1R01CA159013-01A1
- Other IDs
- R01CA159013-01A1
- Status last verified
- Jul 2019
- First submitted
- 29 Sep 2012
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Phipps S, Fairclough DL, Noll RB, Devine KA, Dolgin MJ, Schepers SA, Askins MA, Schneider NM, Ingman K, Voll M, Katz ER, McLaughlin J, Sahler OJZ. In-person vs. web-based administration of a problem-solving skills intervention for parents of children with cancer: Report of a randomized noninferiority trial. EClinicalMedicine. 2020 Jun 27;24:100428. doi: 10.1016/j.eclinm.2020.100428. eCollection 2020 Jul.
PubMed 32637901
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Implementation of Problem Solving Skills Training for Mothers of Newly Diagnosed Childhood Cancer Patients
- ClinicalTrials.gov ID
- NCT01711944
- Acronym / sponsor ID
- 1R01CA159013-01A1
- Conditions
- Childhood Cancer
- Keywords
- childhood cancer, Internet communication, parents, caregivers, problem solving
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 629 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- M.D. Anderson Cancer Center, University of Texas, El Paso, University of Colorado, Denver, University of Pittsburgh, Rutgers Cancer Institute of New Jersey, Children's Hospital Los Angeles, St. Jude Children's Research Hospital, National Institutes of Health (NIH)
- Study start
- Jul 2012
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 22 Oct 2012 (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.
Parents of children newly diagnosed with cancer experience depression and anxiety, especially in the first several months of treatment. Bright IDEAS, an 8-session problem-solving skills training (PSST) program has been used in studies with more than 900 mothers including more than 125 monolingual Spanish-speaking mothers. It has been shown to significantly decrease mothers' distress and to particularly benefit Latina immigrants. This past spring, the NCI/NIH designated Bright IDEAS as a Research-Tested Intervention Program and has included it in the National Registry of Evidence-based Programs and Practices. To date, Bright IDEAS has been available to mothers at only a few cancer centers with specially trained personnel. This proposal is designed to bring Bright IDEAS on-line to make it available to mothers and fathers 24/7 anywhere with Internet access. The investigators will carefully analyze acceptability and use to gain insight into the most promising ways of disseminating interventions like Bright IDEAS using Internet, Internet II, and other emerging technologies.
Detailed description
Research and experience document that caregivers of children with cancer encounter extraordinary stresses during the child's illness. These stresses are particularly severe during diagnosis and early therapy and can interfere significantly with a caregiver's ability to make reasoned and timely decisions on their child's behalf. With increasing survivor rates, it has become evident that decisions made in the early stages of cancer management can have profound long-term effects, adding to the distress caregivers feel trying to make the "right" decisions. Too help mothers of newly diagnosed children cope more effectively with these challenges, the investigators conducted randomized controlled trials (R25CA65520, R01CA098954) to develop, field test, and evaluate the efficacy of the Bright IDEAS paradigm of problem-solving skills training (PSST), a cognitive-behavioral therapy shown to decrease anxiety and depression - two symptoms of post-traumatic stress commonly experienced among this group of mothers. Our findings clearly show that PSST significantly increases problem-solving skills (primary effect) and decreases negative affectivity (secondary effect) in mothers from a variety of racial, ethnic, and socioeconomic backgrounds. Particularly powerful and long-lasting effects were noted in Spanish-speaking mothers, an especially underserved population. In March 2010, the NCI designated Bright IDEAS as a Research-based Therapy/Intervention Program (RTIP) and entered it into the National Registry of Evidence-based Programs and Practices (NREPP). As an 8-session, in-person intervention, Bright IDEAS is labor intensive and, to date, has only been available at a few institutions with trained personnel. However, as a part of the RTIPs evaluation process, the Dissemination Capability of Bright IDEAS was rated 5/5. This proposal is designed to meet the challenge inherent in this perfect score. The investigators will also immediately broaden the scope of users by including fathers as eligible participants in this study of a new delivery paradigm the investigators believe they will find appealing. Aim 1 is implementation of an engaging, easy-to-use on-line version of Bright IDEAS that would be available 24/7 to any person anywhere who has access to the Internet. Aim 2 is the use of "Diffusion of Innovations" theory to craft a framework for disseminating not only Bright IDEAS but other similar interventions with the greatest effectiveness and efficiency. In past studies, the investigators have shown that the human element (time and attention) inherent in in-person interventions is effective in bringing immediate relief of distress but not sufficient to maintain its benefits over time. In contrast, mothers receiving PSST increase their skills and continue to improve their sense of well-being 3 months after the intervention. What the investigators have not investigated is whether a computer-based intervention is as effective as (not inferior to) an in-person intervention. The results will have significant implications for future dissemination strategies, especially the use of Internet II and other emerging technologies.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online PSST | Experimental | Behavioral: Problem-Solving Skills TrainingAn online version of Problem-Solving Skills Training (PSST) will be compared to standard (face-to-face) PSST |
| Face-to-Face PSST | Active comparator | Behavioral: Problem-Solving Skills TrainingThis is an 8-session face-to-face Problem-Solving Skills Training intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 TrainingAlso: PSST, Bright IDEAS, Online PSST, Standard or face-to-face PSST8-session manualized intervention to provide problem-solving skills training in the context of childhood cancer. | Behavioural | Face-to-Face PSST, Online PSST |
Primary outcome
Social Problem Solving Skills Inventory
Time frame: Baseline (T1), post intervention (3 months; T2), 3 months post intervention (6 months; T3)
This is a well validated assessment of problem-solving strategies and positive or negative orientation to problem solving.
2 secondary outcomes
Profile of Mood States
Time frame: Baseline (T1); post intervention (3 months; T2); 3 months post intervention (6 months; T3)
Patient Health Questionnaire (PHQ9)
Time frame: Baseline (T1), post intervention (3 months; T2), 3 months post intervention (6 months; T3)
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 12 Jul 2019.
- Derived from this study: PubMed 32637901Phipps S, Fairclough DL, Noll RB, Devine KA, Dolgin MJ, Schepers SA, Askins MA, Schneider NM, Ingman K, Voll M, Katz ER, McLaughlin J, Sahler OJZ. In-person vs. web-based administration of a problem-solving skills intervention for parents of children with cancer: Report of a randomized noninferiority trial. EClinicalMedicine. 2020 Jun 27;24:100428. doi: 10.1016/j.eclinm.2020.100428. eCollection 2020 Jul.
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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
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Problem-Solving Skills Training in people with Childhood Cancer, run by University of Rochester at 6 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?
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 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
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?
Social Problem Solving Skills Inventory (time frame: Baseline (T1), post intervention (3 months; T2), 3 months post intervention (6 months; T3)). 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 NCT01711944, which also lists 1 linked publication.
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 12 Jul 2019; AzTrials last refreshed its copy on 26 Oct 2026.