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

Trial Summary

What is the purpose of this trial?

The goal of this study is to establish feasibility, acceptability, and proof-of-concept of an psychosocial intervention adapted to address social health needs of adolescents and young adults (AYAs) newly diagnosed with cancer. The aims of this study are to: 1. Determine if the Promoting Resilience in Stress Management - Social Needs (PRISM-SN) adapted intervention is feasible and acceptable, defined via program uptake and retention and patient-reported feedback. 2. Explore whether PRISM-SN improves social outcomes at 12-week follow-up compared to usual care. Participants will be randomized to receive usual psychosocial care or the PRISM-SN program. Participants on both arms will complete patient-reported outcome surveys at enrollment and 12-weeks later. Researchers will compare participants who received the PRISM-SN program to those who received usual care to see if the program improves psychosocial outcomes.

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 data supports the effectiveness of the treatment PRISM-SN for young people with cancer?

Research shows that the PRISM treatment, which is similar to PRISM-SN, has been effective in improving resilience, quality of life, and coping skills in young people with cancer. This suggests that PRISM-SN might also help young people manage stress and improve their overall well-being. ^{1 2 3 4 5}

Is the PRISM-SN intervention safe for young people with cancer?

The available research on the PRISM intervention, which is similar to PRISM-SN, does not report any safety concerns for young people with cancer. It focuses on improving resilience and coping skills without mentioning any harmful effects. ^{1 3 4 5 6}

How is the PRISM-SN treatment different from other treatments for young people with cancer?

PRISM-SN is unique because it focuses on building resilience and improving psychosocial outcomes through skills-based training sessions, unlike traditional treatments that primarily address physical symptoms. It includes stress management, goal-setting, cognitive reframing, and meaning-making, which are tailored to the needs of adolescents and young adults with cancer. ^{1 2 3 4 5}

Research Team

Kaitlyn M Fladeboe, PhD

Principal Investigator

Seattle Children's Hospital

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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-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]

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]

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]

References

1. United States 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. [2022]

2. Switzerland 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Hope and benefit finding: Results from the PRISM randomized controlled trial. [2020]

4. United States 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. [2023]

5. England 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. [2023]

6. Germany 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. [2022]