PRISM for Cancer

(PRISM-AC Trial)

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

195 Participants Needed

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the treatment Promoting Resilience in Stress Management (PRISM) for cancer patients?

Research shows that stress management interventions can reduce distress and improve quality of life for cancer patients. These interventions help patients adapt psychologically and physiologically, which can lead to better health outcomes. ^{1 2 3 4 5}

Is the PRISM stress management program safe for cancer patients?

The research on stress management programs like PRISM for cancer patients focuses on improving quality of life and reducing distress, but it does not specifically mention any safety concerns, suggesting it is generally considered safe. ^{1 2 3 6 7}

How is the PRISM treatment different from other treatments for cancer?

PRISM (Promoting Resilience in Stress Management) is unique because it focuses on enhancing resilience and managing stress, which can improve psychological well-being and potentially influence physical health outcomes in cancer patients. Unlike traditional treatments that target the cancer itself, PRISM aims to help patients cope with the emotional and psychological challenges of cancer diagnosis and treatment. ^{1 3 8 9 10}

Research Team

Abby R Rosenberg, MD, MS, MA

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

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

Stress Management Interventions to Facilitate Psychological and Physiological Adaptation and Optimal Health Outcomes in Cancer Patients and Survivors. [2023]

2. Canada pubmed.ncbi.nlm.nih.gov

A Stress Management App Intervention for Cancer Survivors: Design, Development, and Usability Testing. [2020]

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

Web-Based Stress Management for Newly Diagnosed Patients With Cancer (STREAM): A Randomized, Wait-List Controlled Intervention Study. [2019]

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

Implementing distress management guidelines in ambulatory oncology: a quality improvement project. [2014]

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

Piloting an Automated Distress Management Program in an Oncology Practice. [2017]

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

Stress and Molecular Drivers for Cancer Progression: A Longstanding Hypothesis. [2022]

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

Not seeing the forest for the trees: a systematic review of comprehensive distress management programs and implementation strategies. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Diurnal cortisol rhythms, fatigue and psychosocial factors in five-year survivors of ovarian cancer. [2018]

9. United States 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. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Web-based stress management for newly diagnosed cancer patients (STREAM-1): a randomized, wait-list controlled intervention study. [2018]