The PRISM Intervention: a Multi-site Randomized Controlled Trial for Adolescents and Young Adults With Advanced Cancer

NCT ID: NCT03668223

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 195 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-15
• Study Completion Date: 2025-10-31

Brief Summary

Multi-Site Randomized Controlled Trial testing the efficacy of the Promoting Resilience in Stress Management (PRISM) intervention among Adolescents and Young Adults with Advanced Cancer

Detailed Description

Among patients with cancer and their families, early integration of palliative care may improve quality of life. This is particularly important for Adolescents and Young Adults (AYAs) because their distinct developmental challenges related to identity, relationships, and vocation may add to the burden of cancer. Among AYAs with advanced cancer, most understand that they may die and report that discussing end-of-life preferences, goals, and fears would be helpful; however, only 53% engage in such conversations. While national guidelines call for integrated palliative care in AYA oncology, developmentally targeted, evidence-based interventions designed to meet psychosocial and communication needs are lacking.

A potential barrier to improving the experiences of AYAs with advanced cancer may be their limited opportunities to develop "resilience resources" such as stress-management, goal-setting, positive reframing, and meaning-making skills. These resources may mitigate negative outcomes, facilitate engagement in goals of care discussions, and improve quality of life. Furthermore, promoting these resources among AYAs may give them the tools to more successfully navigate the challenges of the cancer experience.

Our research program is built on the central hypothesis that promoting resilience resources will improve psychosocial well-being. Over a series of studies, we developed a conceptual framework of resilience in pediatric cancer, affirmed associations between resilience resources and outcomes, and developed a novel resilience resources intervention (Promoting Resilience in Stress Management, PRISM). PRISM is a manualized, skills-based training program comprised of four 30-60 minute, in-person, one-on-one sessions plus a facilitated parent/caregiver/spouse/significant other family-meeting.

We completed a pilot Randomized Controlled Trial (RCT) to test the efficacy of PRISM among 100 AYAs, 6-months following their diagnosis of new (n=73) or recurrent (n=27) cancer. Results suggest PRISM is feasible, highly acceptable, and associated with increased patient-reported resilience as well as key clinically significant patient-centered outcomes such as quality of life and psychological distress. Subgroup analyses comparing patients with advanced cancer to those with new cancer suggested differentially stronger positive effects in the advanced cancer group, raising a hypothesis to be tested in dedicated trials. However, qualitative feedback from patients with advanced cancer suggested refinements targeting hopes, worries, and contextual meaning-making might strengthen PRISM's usefulness.

The overall objective of this project is to refine PRISM to meet the distinct needs of AYAs with Advanced Cancer. We will first adapt and iteratively test the existing PRISM based on established guidelines for intervention development. Then, we will conduct a multi-site randomized controlled trial to test the efficacy of a new PRISM for Advanced Cancer (PRISM-AC). Findings will inform the development of larger dissemination studies and standards of AYA end-of-life and palliative care. Ultimately, this research has the potential to reduce the burden of cancer in a highly vulnerable population.

Conditions

Cancer; Quality of Life; Anxiety; Depression; Hope; Coping Skills; Communication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Promoting Resilience in Stress Management (PRISM)

Resilience Skills Training

Group Type: EXPERIMENTAL

Promoting Resilience in Stress Management (PRISM)

Intervention Type: BEHAVIORAL

Manualized skills training targeting resilience resources: stress-management, goal-setting, cognitive reframing, and meaning-making

Usual Care

Standard psychosocial care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Promoting Resilience in Stress Management (PRISM)

Manualized skills training targeting resilience resources: stress-management, goal-setting, cognitive reframing, and meaning-making

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age 12-24 years
• Diagnosed with advanced cancer: progressive, recurrent, refractory disease or any diagnosis with estimated overall survival <50% at least 2 weeks prior to enrollment
• Able to speak English
• Able to read English or Spanish
• Cognitively able to participate in interviews

Exclusion Criteria

• Patient Refusal
• Parent Refusal (if patient <18 years-old)

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital Los Angeles

OTHER

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: collaborator

University of Pittsburgh Medical Center

OTHER

Sponsor Role: collaborator

Seattle Children's Hospital

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Abby Rosenberg

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abby R Rosenberg, MD, MS, MA

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Children's Hospital Los Angeles

Los Angeles, California, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Texas Children's Hospital

Houston, Texas, United States

Seattle Children's Hospital

Seattle, Washington, United States

Countries

United States

References

Rosenbaum ARP, Ream M, Fladeboe KM, Lau N, Yi-Frazier JP, Rosenberg AR. Examining Sociodemographic Differences in Response to Resilience Coaching for Adolescents and Young Adults Receiving Hematopoietic Cell Transplantation-A Post Hoc Analysis of the PRISM Intervention. Pediatr Blood Cancer. 2025 Nov;72(11):e31998. doi: 10.1002/pbc.31998. Epub 2025 Aug 31.

Reference Type: DERIVED

PMID: 40887863 (View on PubMed)

O'Daffer A, Comiskey L, Scott SR, Zhou C, Bradford MC, Yi-Frazier JP, Rosenberg AR. Protocol for the promoting resilience in stress management (PRISM) intervention: a multi-site randomized controlled trial for adolescents and young adults with advanced cancer. BMC Palliat Care. 2023 May 16;22(1):60. doi: 10.1186/s12904-023-01179-4.

Reference Type: DERIVED

PMID: 37189149 (View on PubMed)

O'Daffer A, Comiskey L, Scott SR, Zhou C, Bradford MC, Yi-Frazier JP, Rosenberg AR. Protocol for The Promoting Resilience in Stress Management (PRISM) Intervention: a multi-site randomized controlled trial for adolescents and young adults with advanced cancer. Res Sq [Preprint]. 2023 Apr 7:rs.3.rs-2748874. doi: 10.21203/rs.3.rs-2748874/v1.

Reference Type: DERIVED

PMID: 37066150 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STUDY00001229

Identifier Type: OTHER

Identifier Source: secondary_id

R01CA222486

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22-653

Identifier Type: -

Identifier Source: org_study_id