Resilience-Building Program for Young Cancer Survivors

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Abby Rosenberg, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Cancer therapy, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial tests the PRISM program, a mobile app designed to help people facing serious illnesses manage stress better. It teaches practical skills through multiple sessions delivered via an app, texts, or video calls. The goal is to help participants become more resilient and handle tough situations more effectively.

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 PRISM Program for young cancer survivors?

Research shows that the PRISM Program helps young cancer survivors by improving their quality of life and reducing distress. It also enhances resilience, which means it helps them cope better with the challenges of their illness. ^{1 2 3 4 5}

Is the PRISM Program safe for young cancer survivors?

The PRISM Program, which helps young people with cancer manage stress and build resilience, has been tested in several studies and is generally considered safe for adolescents and young adults. ^{1 2 3 4 6}

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

The PRISM treatment is unique because it focuses on building resilience and improving psychosocial outcomes through skills-based training sessions, specifically designed for adolescents and young adults with cancer. Unlike traditional medical treatments, PRISM enhances coping skills like hopeful thinking and goal setting, which can improve quality of life and reduce distress. ^{1 2 4 5 6}

Research Team

Abby Rosenberg, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for young individuals aged 12 to 25 who are dealing with anxiety or stress due to a serious illness. They must be able to speak and read English or Spanish, and be cognitively capable of participating in sessions and completing surveys as judged by the investigator.

Inclusion Criteria

I am between 12 and 25 years old.

I am mentally capable of participating in sessions and completing surveys.

I can speak English or Spanish.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the PRISM program through app, text, or video sessions, including baseline and 3-month questionnaires

3 months

Multiple sessions via app, text, or video

Re-randomization and Continued Treatment

Participants may be re-randomized to different groups or referred to psychosocial support, continuing PRISM sessions until the final survey

3 months

Continued sessions via app, text, or video

Follow-up

Participants are monitored for resilience and quality of life outcomes after completing the PRISM program

4 weeks

Treatment Details

Interventions

• PRISM Program (Behavioral Intervention)

Trial Overview The study tests the 'Promoting Resilience in Stress Management' (PRISM) program, which includes an app with six sessions aimed at teaching skills to manage stress better and improve resilience during tough times.

Participant Groups

Group I: PRISM Program Mobile App Experimental Treatment 1 Intervention

Participants will be randomized to "app-only" group and will complete: * Baseline questionnaire. * mPRISM App self guided modules * 3 month questionnaire. * mPRISM App self guided modules until final survey at 6 months and end of participation.

Group II: PRISM Program Video Coach Active Control 2 Interventions

Participants will be randomized to "video" group and will complete: * Baseline questionnaire. * PRISM sessions. * 3 month questionnaire with re-randomization to either "app-only" or "text" groups or referral to specialty psychosocial support. * After re-randomization, participants will complete PRISM sessions until final survey at 6 months and end of participation.

Group III: PRISM Program Text Coach Active Control 2 Interventions

Participants will be randomized to "text" group and will complete: * Baseline questionnaire. * PRISM sessions. * 3 month questionnaire with re-randomization to "app-only," "text," or "video" groups. * After re-randomization, participants will complete PRISM sessions until final survey at 6 months and end of participation.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Dr. Benjamin L. Ebert

Dana-Farber Cancer Institute

Chief Executive Officer

MD from Harvard Medical School, PhD from Oxford University

Dr. Craig A. Bunnell

Dana-Farber Cancer Institute

Chief Medical Officer since 2012

MD from Harvard Medical School, MPH from Harvard School of Public Health, MBA from MIT Sloan School of Management

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

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 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]

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. 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]

4. England pubmed.ncbi.nlm.nih.gov

The Promoting Resilience in Stress Management (PRISM) intervention for adolescents and young adults receiving hematopoietic cell transplantation: a randomized controlled trial protocol. [2022]

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

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

6. 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]