Resilience-Building Program for Young Cancer Survivors

Recruiting at 1 trial location

Overseen By Abby Rosenberg, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Cancer therapy, 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: Unknown

Duration: 3 months

325 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help young cancer survivors and their families manage stress and build resilience after facing serious illness. Participants will use the PRISM program, a mobile app with six sessions focused on stress management skills. The study will compare three groups—app-only, video coach, and text coach—to determine the best method for fostering resilience. Young people aged 12 to 25 who have completed their main cancer treatment and can speak and read English or Spanish might be a good fit for this trial. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance support for young cancer survivors.

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 Program is safe for young cancer survivors?

Research shows that the PRISM program helps people manage stress and build resilience. It teaches skills such as handling stress, setting goals, and thinking positively. Studies have found the program to be safe. Participants in earlier research did not experience unexpected distress. The program ensures participants feel supported and not overwhelmed. Overall, PRISM aims to prepare people to handle stress effectively without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PRISM Program for young cancer survivors because it offers a fresh approach to building resilience. Unlike traditional psychosocial support, which often involves in-person therapy or counseling, the PRISM Program leverages digital platforms, including a mobile app and video or text coaching, making it more accessible and flexible for young survivors. This program is designed to be self-guided and interactive, encouraging participants to engage with the material at their own pace. By re-randomizing participants, the program can also adapt to individual needs, potentially offering more personalized support options. This innovative approach aims to empower young survivors with tools to manage stress and improve their overall well-being, which is why researchers are keen to explore its effectiveness.

What evidence suggests that the PRISM Program is effective for building resilience in young cancer survivors?

Research shows that the PRISM program, available in various formats to trial participants, helps young people with serious illnesses become more resilient and feel less psychological distress. One study found that after three months, participants experienced a noticeable increase in resilience and hope. Specifically, their resilience scores increased by an average of 1.3 points, while those not using PRISM saw a decrease. The program teaches stress management skills, which can greatly improve daily life. Overall, studies support PRISM as a valuable tool for building resilience and enhancing well-being among young cancer survivors. ^{2 6 7 8 9}

Who Is on the Research Team?

Abby Rosenberg, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• PRISM Program

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.

How Is the Trial Designed?

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.

PRISM Program is already approved in United States for the following indications:

Approved in United States as PRISM Program for:

• Psychosocial support for adolescents and young adults with cancer

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

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 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 ongoing randomized-controlled trial aims to evaluate the efficacy of the PRISM resilience-coaching program in reducing depression and anxiety among adolescents and young adults (AYAs) receiving hematopoietic cell transplantation (HCT) for cancer, with a target enrollment of 90 participants across four US centers.

The PRISM intervention includes four coaching sessions focused on stress management and cognitive restructuring, and it is hypothesized that AYAs receiving PRISM will report lower levels of psychological distress compared to those receiving standard psychosocial care, with outcomes assessed at 3 and 6 months post-enrollment.

NCBI (Pubmed)

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. Fladeboe, KM., Scott, S., Comiskey, L., 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]

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Promoting Resilience in Stress Management (PRISM)

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This manualized, brief intervention targets skills in stress-management and mindfulness, goal-setting, positive reframing, and meaning-making.

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