PRISM for Parents of Children With Cancer Promoting Resilience in Stress Management (PRISM) Intervention for Parents of Children With Cancer

Study Overview
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Brief Summary
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Parenting a child with cancer is highly stressful. The investigators have designed a promising parent-centered intervention to bolster parent resilience and reduce stress and distress. This study will test 2 formats of the intervention (individual or group-based) and compare them to usual care.

Detailed Description
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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.

Official Title
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A Pilot Randomized Controlled Trial of the Promoting Resilience in Stress Management (PRISM) Intervention for Parents of Children With Cancer

Conditions
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Pediatric Cancer

Intervention / Treatment
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* Behavioral: Promoting Resilience in Stress Management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individual (1:1)<br>Individual, 1:1 version of the Promoting Resilience in Stress Management for Parents (PRISM-P) intervention | Behavioral: Promoting Resilience in Stress Management<br>* Skills-based intervention designed to promote resilience resources<br>* Other names: PRISM;|
| Experimental: Group<br>Group-based version of the Promoting Resilience in Stress Management for Parents (PRISM-P) intervention | Behavioral: Promoting Resilience in Stress Management<br>* Skills-based intervention designed to promote resilience resources<br>* Other names: PRISM;|
| No Intervention: Usual Care<br>Usual non-directed psychosocial supportive care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent-Reported Resilience |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent-reported Stress Survey Response |  | 3 months | 
| Parent-reported psychological distress Survey Response |  | 3 months | 
| Parent-reported social support Survey Response |  | 3 months | 
| Parent-reported quality of life Survey Response |  | 3 months | 
| Parent-reported benefit finding Survey Response |  | 3 months |