PRISM-SN for Young People with Cancer

Overseen By Kaitlyn M Fladeboe, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Seattle Children's Hospital

Disqualifiers: Recurrent malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program called PRISM-SN, designed to help young people recently diagnosed with cancer. The goal is to determine if this program better manages social and emotional challenges compared to usual support. Participants will either undergo the PRISM-SN program or continue with standard care, with researchers comparing results after 12 weeks. This trial suits individuals aged 12 to 25 who have been diagnosed with cancer in the past six months and are undergoing chemotherapy or radiation. As an unphased trial, it offers a unique opportunity to contribute to innovative support strategies for young cancer patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on a psychosocial intervention, so it's likely you can continue your medications, but please confirm with the trial coordinators.

What prior data suggests that the PRISM-SN intervention is safe for young people with cancer?

Research shows that the PRISM-SN program offers a new way for young people with cancer to manage stress and enhance their social lives. This program builds on earlier versions of PRISM, which have proven effective in helping young adults with cancer become more resilient and less distressed.

The original PRISM program received positive feedback, with no reports of negative effects. Participants generally found it helpful in improving their quality of life. As PRISM-SN is a version of this proven program, it is expected to be both safe and beneficial.

No specific negative effects have been reported with PRISM-SN. Participants in similar programs often report feeling more hopeful and better equipped to handle stress. This suggests that PRISM-SN is likely safe for young people with cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PRISM-SN program because it offers a fresh approach to supporting young people with cancer by focusing on building resilience and managing stress related to their social needs. Unlike standard psychosocial care, which primarily involves emotional and mental health support, PRISM-SN is a skill-based program that actively teaches young patients how to cope with the stress of their illness and its impact on their social lives. This hands-on approach aims to empower patients with practical tools for resilience, potentially leading to improved quality of life and better overall well-being during their cancer journey.

What evidence suggests that the PRISM-SN intervention is effective for improving social outcomes in young people with cancer?

Research has shown that the Promoting Resilience in Stress Management (PRISM) program can quickly boost resilience and hope in teenagers and young adults with cancer. These positive effects may last a long time, enhancing their overall quality of life. Studies also suggest that positive psychology techniques like PRISM improve well-being and reduce stress in this group. In this trial, participants will receive either standard psychosocial care or the new version, PRISM-SN. This short, structured plan aims to help young people with cancer by strengthening mental resilience and focusing on meeting social health needs while managing stress. ^{4 6 7 8 9}

Who Is on the Research Team?

Kaitlyn M Fladeboe, PhD

Principal Investigator

Seattle Children's Hospital

Are You a Good Fit for This Trial?

This trial is for English-speaking adolescents and young adults aged 12-25 who have been diagnosed with cancer within the last 6 months and are undergoing chemotherapy or radiation. They must be able to read English and cognitively participate in sessions and surveys.

Inclusion Criteria

I am between 12 and 25 years old.

I was diagnosed and treated for a new cancer with chemo or radiation in the last 6 months.

I can speak English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment

Participants complete patient-reported outcome surveys at enrollment

1 week

1 visit (in-person)

Intervention

Participants receive the PRISM-SN program or usual psychosocial care

12 weeks

4 visits (in-person or virtual)

Follow-up

Participants are monitored for social and psychological outcomes

12 weeks

1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Promoting Resilience in Stress Management - Social Needs (PRISM-SN)

Trial Overview

The study tests a psychosocial intervention called PRISM-SN, designed to help young cancer patients manage stress related to social needs. Participants will either receive this program or usual care, with outcomes compared after 12 weeks.

How Is the Trial Designed?

Group I: PRISM-SN Intervention Experimental Treatment 1 Intervention

Skill-based psychosocial program

Group II: Usual Care Active Control 1 Intervention

Standard psychosocial care

Who Is Running the Clinical Trial?

Seattle Children's Hospital

Lead Sponsor

Trials

319

Recruited

5,232,000+

University of Pittsburgh Medical Center

Collaborator

Trials

78

Recruited

77,600+

Published Research Related to This Trial

The PRISM intervention, a skills-based coaching program for adolescents and young adults with cancer, led to significant improvements in quality of life, hope, and resilience, with these benefits sustained for up to 24 months after the program ended.

Among participants who showed initial improvement after 6 months, those in the PRISM group were more likely to maintain their positive outcomes in quality of life and psychological well-being compared to those receiving usual care, indicating the long-term efficacy of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of the Promoting Resilience in Stress Management Intervention for Adolescent and Young Adult Survivors of Cancer at 2 Years: Secondary Analysis of a Randomized Clinical Trial. Rosenberg, AR., Zhou, C., Bradford, MC., et al.[2022]

In a study involving 92 adolescents and young adults with cancer, 60% reported experiencing one or more traumatic events, which is consistent with rates seen in the general population.

The resilience intervention, Promoting Resilience in Stress Management (PRISM), significantly improved feelings of benefit-finding and hope in those who had experienced traumatic events, suggesting it may be particularly effective for this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse childhood experiences (ACEs) and medically traumatic events (TEs) in adolescents and young adults (AYAs) with cancer: a report from the Promoting Resilience in Stress Management (PRISM) randomized controlled trial. Scott, SR., O'Daffer, AG., Bradford, MC., et al.[2022]

The PRISM intervention significantly improved coping skills related to benefit finding and hopeful thinking in adolescents and young adults with cancer, with moderate-to-large effect sizes observed in a study of 92 participants.

Despite the positive effects on benefit finding and hope, PRISM did not show a significant impact on goal setting, suggesting that while it enhances certain coping strategies, further development may be needed to address goal-setting skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hope and benefit finding: Results from the PRISM randomized controlled trial. Rosenberg, AR., Bradford, MC., Barton, KS., et al.[2020]

The PRISM intervention, which includes four skills-based training sessions, significantly improved health-related quality of life (HRQOL) in adolescents and young adults with cancer compared to usual care, particularly in psychosocial areas.

Participants in the PRISM group showed more positive changes in specific HRQOL subdomains, such as treatment anxiety and cognitive function, indicating that PRISM effectively enhances resilience and overall wellbeing in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Psychosocial Intervention's Impact on Quality of Life in AYAs with Cancer: A Post Hoc Analysis from the Promoting Resilience in Stress Management (PRISM) Randomized Controlled Trial. Steineck, A., Bradford, MC., Lau, N., et al.[2022]

The PRISM-AC trial aims to evaluate the effectiveness of a new resilience training program for adolescents and young adults (AYAs) with advanced cancer, involving 144 participants across multiple sites, focusing on improving their health-related quality of life and reducing distress.

This intervention includes skills-based training in stress management and goal-setting, along with a family meeting and a smartphone app, potentially offering a comprehensive approach to support AYAs and their caregivers during a challenging time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for the promoting resilience in stress management (PRISM) intervention: a multi-site randomized controlled trial for adolescents and young adults with advanced cancer. O'Daffer, A., Comiskey, L., Scott, SR., et al.[2023]

The PRISM-AC trial aims to evaluate the effectiveness of a new intervention designed to improve psychosocial outcomes for adolescents and young adults (AYAs) with advanced cancer, involving 144 participants across multiple sites.

This intervention includes skills-based training in resilience resources and aims to enhance health-related quality of life, reduce anxiety and depression, and support family involvement, potentially offering a valuable resource for this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for The Promoting Resilience in Stress Management (PRISM) Intervention: a multi-site randomized controlled trial for adolescents and young adults with advanced cancer. O'Daffer, A., Comiskey, L., Scott, SR., et al.[2023]

Citations

1.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.10009

Promoting Resilience in Stress Management (PRISM)

A novel resilience coaching intervention led to immediately improved resilience and hope, and longer-term improvements in quality of life among AYAs with ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10186689/

Protocol for the promoting resilience in stress management ...

This study will provide methodologically rigorous data and evidence regarding a novel intervention to promote resilience and reduce distress among AYAs with ...

3.

reporter.nih.gov

reporter.nih.gov/project-details/10895146

Project Details

We have previously described the “Promoting Resilience in Stress Management” (PRISM) intervention for AYAs with cancer. This manualized, brief intervention is ...

4.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2786546

Assessment of the Promoting Resilience in Stress ...

The findings of this study suggest that positive psychology interventions such as PRISM may bolster durable well-being among adolescent and young adult ...

5.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/94/NCT03847194/Prot_SAP_000.pdf

The Promoting Resilience in Stress Management (PRISM) ...

Resilience Among Adolescents and Young Adults with Cancer. J Adolesc Young Adult Oncol. 2014;3(4):185-193. 23. Rosenberg AR, Baker KS, Syrjala KL, Back AL ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06242964

The PRISM-Social Needs (PRISM-SN) Intervention for ...

Researchers will compare participants who received the PRISM-SN program to those who received usual care to see if the program improves psychosocial outcomes.

7.

cancer.gov

cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-07663

Promoting Resilience in Stress Management (PRISM) for ...

Participating in PRISM may improve resilience, distress, hope, and quality of life in young adults with cancer or desmoid tumor. Eligibility Criteria ...

8.

reporter.nih.gov

reporter.nih.gov/project-details/10879334

RePORT RePORTER

We created “Promoting Resilience in Stress Management” (PRISM): a novel, brief, skills-based program promoting AYA-endorsed “resilience resources” (stress- ...

9.

tandfonline.com

tandfonline.com/doi/full/10.1080/07347332.2024.2419663

Adaptation and feasibility of the Swedish Promoting ...

PRISM is a 5-session, manualized program designed to strengthen AYAs individual resources for managing stress by promoting resilience skills.