- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02998086
PRISM for Parents of Children With Cancer Promoting Resilience in Stress Management (PRISM) Intervention for Parents of Children With Cancer
A Pilot Randomized Controlled Trial of the Promoting Resilience in Stress Management (PRISM) Intervention for Parents of Children With Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Parenting a child with cancer is highly distressing. Both during and after cancer therapy, parents may suffer from poor mental health, risky health behaviors, and financial hardship, all of which may impact patients, siblings, and the family unit. Positive psychological resources can mitigate negative outcomes. In this regard, resilience is particularly important, describing an individual's ability to maintain psychological and/or physical well-being in the face of stress.
The investigators have previously described the "Promoting Resilience in Stress Management" (PRISM) intervention for adolescent and young adult patients with cancer. This brief, 1:1 intervention targets four "resilience resources" over approximately 3 months: skills in stress-management/mindfulness, goal-setting, cognitive restructuring, and meaning-making. Notably, every parent whose child received the PRISM requested a similar intervention for him- or herself. Hence, the investigators adapted two versions of the intervention for parents (the "PRISM-P"). First, using the same 1:1 format, they piloted the PRISM-P amongst 12 parents of children with cancer. Feedback was highly positive; however, many parents requested additional group-based social support. Second, they conducted a half-day symposium and administered small-group adaptations of the PRISM-P to 70 parents of children with serious illness. Feedback was again positive; however, the opportunity to develop individual skills was limited.
This application proposes a pilot Randomized Clinical Trial (RCT) to evaluate and compare these 2 formats of the PRISM-P with usual care, in order to determine optimal methodologies and preferences for future, larger studies. Consecutive eligible parents of children with newly diagnosed cancer will be randomly assigned to one of the 3 options (N=75 total, n=25 per arm). Secondary aims will assess parent-reported stress, burden of care, hope, goals, optimism, benefit-finding, psychological distress, and health behaviors, and ongoing perceptions of usefulness, feasibility, and preference.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98145
- Seattle Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: Parents of children who:
- Are aged 2-24 years
- Have been diagnosed with new malignancy between 1-10 weeks prior
- Are scheduled to receive cancer-directed therapy at Seattle Children's Hospital
- Has provided written informed consent (child aged 18 years and older), written assent (child aged 13-17 years), verbal assent (child aged 7-12 years).
- Able to speak and read English language
- Cognitively able to participate in interactive interviews
Exclusion Criteria:
- Parent is < 18 years of age
- Parent is cognitively or physically unable to participate in interactive interview
- Parent is unable to speak and read English language
- Parent or child participated on prior PRISM intervention study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Individual (1:1)
Individual, 1:1 version of the Promoting Resilience in Stress Management for Parents (PRISM-P) intervention
|
Skills-based intervention designed to promote resilience resources
Other Names:
|
Experimental: Group
Group-based version of the Promoting Resilience in Stress Management for Parents (PRISM-P) intervention
|
Skills-based intervention designed to promote resilience resources
Other Names:
|
No Intervention: Usual Care
Usual non-directed psychosocial supportive care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Parent-Reported Resilience
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Parent-reported Stress Survey Response
Time Frame: 3 months
|
3 months
|
Parent-reported psychological distress Survey Response
Time Frame: 3 months
|
3 months
|
Parent-reported social support Survey Response
Time Frame: 3 months
|
3 months
|
Parent-reported quality of life Survey Response
Time Frame: 3 months
|
3 months
|
Parent-reported benefit finding Survey Response
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Rosenberg AR, Zhou C, Bradford MC, Barton K, Junkins CC, Taylor M, Kross EK, Curtis JR, Dionne-Odom JN, Yi-Frazier JP. Parent Perspectives after the PRISM-P Randomized Trial: A Mixed-Methods Analysis. J Palliat Med. 2021 Sep;24(10):1505-1515. doi: 10.1089/jpm.2020.0720. Epub 2021 Mar 15.
- Rosenberg AR, Bradford MC, Junkins CC, Taylor M, Zhou C, Sherr N, Kross E, Curtis JR, Yi-Frazier JP. Effect of the Promoting Resilience in Stress Management Intervention for Parents of Children With Cancer (PRISM-P): A Randomized Clinical Trial. JAMA Netw Open. 2019 Sep 4;2(9):e1911578. doi: 10.1001/jamanetworkopen.2019.11578.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SC-N120
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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