PRISM for Cancer

(PRISM-AC Trial)

Not currently recruiting at 6 trial locations

Overseen By Liam Comiskey, BA

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Patient refusal, Parent refusal, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a program called Promoting Resilience in Stress Management (PRISM) for teens and young adults with advanced cancer. The goal is to determine if PRISM provides better emotional support than usual care. Participants will learn skills to manage stress and build resilience. Those aged 12 to 24 with advanced cancer who can participate in interviews might be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to research that could improve emotional support for young cancer patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the PRISM intervention is safe for adolescents and young adults with advanced cancer?

Research has shown that the Promoting Resilience in Stress Management (PRISM) program is safe for teens and young adults with cancer. Studies have found that PRISM includes four coaching sessions that help patients manage stress, set goals, change negative thoughts, and find meaning in their experiences.

These studies have reported no serious side effects. The program focuses on building resilience, helping individuals recover from stress. It is well-tolerated, with no harmful effects linked to it. This suggests that the PRISM program is safe to try and could improve mental well-being during challenging times like cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about PRISM for cancer patients because it offers a fresh approach to dealing with the psychological stress of the disease. Unlike traditional psychosocial care, which often focuses on providing general emotional support, PRISM emphasizes resilience skills training. This means it actively teaches patients how to manage stress and bounce back from challenges. By building these skills, PRISM aims to improve patients' overall well-being and quality of life during treatment, offering a proactive way to handle the emotional side of cancer.

What evidence suggests that the PRISM intervention is effective for adolescents and young adults with advanced cancer?

Research has shown that the Promoting Resilience in Stress Management (PRISM) program, which participants in this trial may receive, can help teenagers and young adults with advanced cancer. In past studies, PRISM boosted resilience and reduced stress. For example, after three months, participants in PRISM reported feeling more resilient and hopeful than those who did not participate. Another study demonstrated that PRISM improved aspects of patients' overall well-being. These results suggest that PRISM may help young cancer patients manage stress better and enhance their emotional health. ^{3 6 7 8 9}

Who Is on the Research Team?

Abby R Rosenberg, MD, MS, MA

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adolescents and young adults aged 12-24 with advanced cancer, who can speak and read English or Spanish. They should be cognitively able to participate in interviews. It's not open to those whose parents refuse participation (if under 18) or if the patient themselves refuses.

Inclusion Criteria

I am between 12 and 24 years old.

My advanced cancer is getting worse or not responding to treatment.

I am mentally capable of participating in interviews.

Exclusion Criteria

I have chosen not to participate in certain treatments.

My parents have not refused participation in the trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Adaptation

Adapt and iteratively test the existing PRISM intervention based on established guidelines for intervention development

4-8 weeks

Treatment

Participants receive the PRISM intervention, which includes four 30-60 minute, in-person, one-on-one sessions plus a facilitated family meeting

4 weeks

4 visits (in-person), 1 family meeting

Follow-up

Participants are monitored for psychosocial well-being and quality of life outcomes

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Promoting Resilience in Stress Management (PRISM)

Trial Overview The PRISM intervention is being tested in this study across multiple sites. The goal of PRISM is to help these young individuals manage stress, improve resilience, and enhance their quality of life while dealing with advanced cancer.

How Is the Trial Designed?

Group I: Promoting Resilience in Stress Management (PRISM) Experimental Treatment 1 Intervention

Resilience Skills Training

Group II: Usual Care Active Control 1 Intervention

Standard psychosocial care

Promoting Resilience in Stress Management (PRISM) is already approved in United States for the following indications:

Approved in United States as PRISM for:

• Chronic Musculoskeletal Pain in Adolescents

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Pittsburgh Children's Hospital

Collaborator

Trials

1

Recruited

200+

Children's Hospital Los Angeles

Collaborator

Trials

257

Recruited

5,075,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

University of Pittsburgh Medical Center

Collaborator

Trials

78

Recruited

77,600+

Seattle Children's Hospital

Collaborator

Trials

319

Recruited

5,232,000+

Baylor College of Medicine

Collaborator

Trials

1,044

Recruited

6,031,000+

Published Research Related to This Trial

Cancer patients experience significant stress that can negatively impact their quality of life and may even promote tumor growth and metastasis, highlighting the importance of effective stress management.

Randomized controlled trials have shown that stress management interventions can improve psychological and physiological adaptation, potentially leading to better health outcomes for cancer patients and survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stress Management Interventions to Facilitate Psychological and Physiological Adaptation and Optimal Health Outcomes in Cancer Patients and Survivors. Antoni, MH., Moreno, PI., Penedo, FJ.[2023]

The STREAM intervention, a web-based stress management program for newly diagnosed cancer patients, aims to improve quality of life and reduce anxiety and depression through eight modules with minimal psychologist contact, involving 120 participants in a controlled trial.

This study is significant as it explores the feasibility and efficacy of online psychological support for cancer patients, potentially offering a cost-effective and accessible alternative to traditional face-to-face therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-based stress management for newly diagnosed cancer patients (STREAM-1): a randomized, wait-list controlled intervention study. Grossert, A., Urech, C., Alder, J., et al.[2018]

A new electronic stress management intervention called StressProffen was developed for cancer survivors, based on user-centered design principles and input from 48 stakeholders, including cancer survivors and healthcare providers.

The intervention was tailored to be mobile-friendly and user-friendly, emphasizing brief content and easy access, which aligns with cancer survivors' preferences for managing stress effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Stress Management App Intervention for Cancer Survivors: Design, Development, and Usability Testing. Børøsund, E., Mirkovic, J., Clark, MM., et al.[2020]

The SMART (Stress Management and Resiliency Training) program significantly improved resilience, reduced perceived stress and anxiety, and enhanced quality of life in 25 women with breast cancer over a 12-week period, compared to a control group.

The intervention, which included group training sessions and follow-up calls, was found to be feasible and effective, indicating that brief resilience training can be beneficial for breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stress Management and Resilience Training (SMART) program to decrease stress and enhance resilience among breast cancer survivors: a pilot randomized clinical trial. Loprinzi, CE., Prasad, K., Schroeder, DR., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12209016/

Promoting resilience in stress management (PRISM) for ... PRISM is a manualized, skills-based, psychosocial intervention shown to promote resilience and alleviate psychological distress among adolescents and young ...

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

Promoting Resilience in Stress Management (PRISM) At 3-months, PRISM-AYAs reported significantly more improved resilience [mean change-score +1.3 (5.9) vs -1.4 (7.5), p=0.038] and hope [+2.4 ( ...

3. jpsmjournal.com jpsmjournal.com/article/S0885-3924(17)30773-X/fulltext

The “Promoting Resilience in Stress Management” (PRISM ... Conclusion. A targeted intervention targeting skills for AYAs with cancer was effective in improving patient-centered outcomes. Implications for Research, ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2786546

Assessment of the Promoting Resilience in Stress ... This secondary analysis of long-term follow-up data from a randomized clinical trial examines the effectiveness of the Promoting Resilience ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03668223

Study Details | NCT03668223 | The PRISM Intervention: a ... Over a series of studies, we developed a conceptual framework of resilience in pediatric cancer, affirmed associations between resilience resources and outcomes ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9117082/

The Promoting Resilience in Stress Management (PRISM ... The PRISM program includes four scripted coaching sessions targeting skills in stress-management, goal setting, cognitive-restructuring, and ...

7. 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 ...

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

Promoting Resilience in Stress Management (PRISM) for ... PRISM is a brief, skills-based intervention targeting 4 resilience resources (stress management, cognitive reframing, goal setting, and meaning-making)

9. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/10.1002/cncr.31666

Promoting resilience in adolescents and young adults with ... In this randomized trial, adolescents and young adults with cancer who received the Promoting Resilience in Stress Management intervention ...