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

Pediatric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02998086
• Other study ID #: SC-N120
• Status: Completed
• Phase: N/A
• Start date: December 5, 2016
• Est. completion date: December 2020

Study information

• Verified date: March 2021
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: December 2020
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pediatric Cancer

Intervention

Behavioral:
• Promoting Resilience in Stress Management
Skills-based intervention designed to promote resilience resources

Locations

Country	Name	City	State
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parent-Reported Resilience		3 months
Secondary	Parent-reported Stress Survey Response		3 months
Secondary	Parent-reported psychological distress Survey Response		3 months
Secondary	Parent-reported social support Survey Response		3 months
Secondary	Parent-reported quality of life Survey Response		3 months
Secondary	Parent-reported benefit finding Survey Response		3 months