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

NCT ID: NCT02998086

Last Updated: 2021-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-05
• Study Completion Date: 2020-12-31

Brief 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.

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.

Conditions

Pediatric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Individual (1:1)

Individual, 1:1 version of the Promoting Resilience in Stress Management for Parents (PRISM-P) intervention

Group Type: EXPERIMENTAL

Promoting Resilience in Stress Management

Intervention Type: BEHAVIORAL

Skills-based intervention designed to promote resilience resources

Group

Group-based version of the Promoting Resilience in Stress Management for Parents (PRISM-P) intervention

Group Type: EXPERIMENTAL

Promoting Resilience in Stress Management

Intervention Type: BEHAVIORAL

Skills-based intervention designed to promote resilience resources

Usual Care

Usual non-directed psychosocial supportive care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Promoting Resilience in Stress Management

Skills-based intervention designed to promote resilience resources

Intervention Type: BEHAVIORAL

Other Intervention Names

PRISM

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seattle Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Abby Rosenberg

Associate Professor, Pediatrics, University of Washington

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seattle Children's Hospital

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33720787 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31532518 (View on PubMed)

Other Identifiers

SC-N120

Identifier Type: -

Identifier Source: org_study_id