Resilience Mobile App for Teens and Young Adults With Cancer

Overseen By Nancy Lau, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Seattle Children's Hospital

Disqualifiers: Relapsed, recurrent, refractory, others

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

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app called mPRISM (Promoting Resilience in Stress Management), designed to help teens and young adults with cancer manage stress and improve their quality of life. The researchers aim to determine if the app is user-friendly and beneficial for mental health. Participants will either begin using the app immediately or after three months, while continuing their usual care. Ideal candidates for this trial are those aged 12 to 25 who have been diagnosed with cancer in the past year and are receiving treatment at Seattle Children's Hospital. As an unphased trial, this study allows participants to contribute to innovative research that could enhance stress management 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. It seems focused on using a mobile app to help with stress management, so it's unlikely to require changes to your medication.

What prior data suggests that the mPRISM app is safe for teens and young adults with cancer?

Research has shown that the Promoting Resilience in Stress Management (PRISM) program is safe for young people with cancer. Early results from past studies indicate that participants handled it well, with no serious side effects reported. The PRISM program aims to improve mental health and quality of life, unlike treatments that might cause physical side effects.

Since PRISM is a mobile app, the main concern is its effectiveness, not physical safety. Previous research suggests that using PRISM can help young cancer patients become more resilient and less stressed. This evidence supports its safety and potential benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the mPRISM mobile app because it offers a new way to support emotional and psychological resilience in teens and young adults with cancer. Unlike standard care, which typically involves non-directed supportive care and social worker support, mPRISM provides a structured, interactive platform that users can engage with directly. This app could empower young patients to better manage the emotional challenges of cancer treatment by providing tailored support and coping strategies right at their fingertips. The uniqueness of mPRISM lies in its accessibility and potential to deliver personalized mental health resources, making it a promising addition to the current landscape of supportive care.

What evidence suggests that the mPRISM app is effective for improving quality of life and mental health in teens and young adults with cancer?

Research has shown that the Promoting Resilience in Stress Management (PRISM) program can help young adults with cancer feel more resilient and hopeful. One study revealed that participants felt stronger and more hopeful after using PRISM, demonstrating a clear positive change. Another study found that PRISM improved quality of life, resilience, and mental health. The program teaches skills like managing stress and setting goals. This trial will test the mPRISM app, based on the PRISM program, to determine if it can effectively enhance mental well-being and resilience in teens and young adults with cancer. Participants in the experimental arm will receive mPRISM, while those in the waitlist control arm will receive it after completing 3-month follow-up surveys. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for young individuals aged 12-25 who have been diagnosed with cancer within the last 6 months and are undergoing chemotherapy or radiation at Seattle Children's Hospital. They must be able to communicate in English or Spanish and participate in mobile health interventions.

Inclusion Criteria

I am mentally capable of engaging in health-related mobile app interventions and interviews.

I am between 12 and 25 years old.

I was diagnosed with a new cancer and treated at SCH within the last year.

Exclusion Criteria

I am unable to engage in mobile health activities or surveys due to physical or cognitive reasons.

I, or my parents if I'm under 18, do not consent to participate.

My cancer has come back or is not responding to treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline study surveys before receiving the mPRISM intervention

1 week

Intervention

Participants in the experimental arm receive the mPRISM intervention

3 months

Follow-up

Participants are monitored for changes in usability, quality of life, distress, anxiety, depression, and resilience

3 months

What Are the Treatments Tested in This Trial?

Interventions

• mPRISM

Trial Overview

The study is testing a mobile app called mPRISM, designed to boost resilience during stress management. It aims to see if the app is user-friendly, acceptable to patients, and effective in improving their quality of life and mental health.

How Is the Trial Designed?

Group I: mPRISM Experimental Treatment 1 Intervention

The Experimental (mPRISM) arm will receive mPRISM upon completion of their baseline study surveys.

Group II: Waitlist control Experimental Treatment 1 Intervention

Usual Care (UC) available to both study arms consists of standard non-directed supportive care provided for all patients including an assigned social worker throughout cancer treatment. In a waitlist design, the UC arm will receive mPRISM upon completion of 3-month follow-up surveys.

Who Is Running the Clinical Trial?

Seattle Children's Hospital

Lead Sponsor

Trials

319

Recruited

5,232,000+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Published Research Related to This Trial

Adolescents and young adults with cancer have significantly worse outcomes compared to younger and older patients, partly due to low participation in clinical trials and a lack of focus on their unique perspectives in research.

The authors advocate for a shift towards meaning-based research models that utilize qualitative methods to develop psychosocial interventions, emphasizing positive health concepts like hope and coping strategies to better support AYA patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The adolescent/young adult experience. Haase, JE., Phillips, CR.[2019]

In a study involving 449 patients with nonmetastatic cancer, those using an app-based cognitive behavioral stress management (CBSM) showed significant reductions in anxiety and depression symptoms over 12 weeks compared to a health education sham app.

Patients using the CBSM app reported a greater perception of improvement in their anxiety and depression symptoms, indicating that this digital intervention is effective in managing emotional distress in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Cognitive Behavioral Digital Therapeutic on Anxiety and Depression Symptoms in Patients With Cancer: A Randomized Controlled Trial. Zion, SR., Taub, CJ., Heathcote, LC., et al.[2023]

The study aims to understand how daily contextual factors, like mood, influence adherence to the oral chemotherapy drug 6-mercaptopurine (6-MP) among adolescents and young adults with cancer, which is crucial for preventing cancer relapse.

Using an ecological momentary assessment app called ADAPTS, the research is testing various engagement strategies to improve survey completion rates, with 60% of the targeted 30 AYA-caregiver dyads already enrolled and showing promising engagement in the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding Adolescent and Young Adult 6-Mercaptopurine Adherence and mHealth Engagement During Cancer Treatment: Protocol for Ecological Momentary Assessment. Psihogios, AM., Rabbi, M., Ahmed, A., et al.[2023]

A study involving 83 adolescent and young adult cancer patients and 34 healthcare professionals revealed significant discrepancies in how health-related quality of life (HRQoL) issues are perceived, with patients rating their overall quality of life and support more positively than healthcare professionals.

Healthcare professionals identified more physical symptoms and distress related to cancer diagnosis and treatment as problematic, while patients emphasized perceived support and overall happiness, highlighting the need for better communication and patient involvement in care planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health-Related Quality of Life Issues in Adolescents and Young Adults with Cancer: Discrepancies with the Perceptions of Health Care Professionals. Kaal, SEJ., Lidington, EK., Prins, JB., et al.[2021]

The Stress Proffen app-based intervention for cancer survivors showed significant reductions in stress, anxiety, and self-regulatory fatigue, along with improvements in health-related quality of life, based on a pilot study with 25 participants.

Participants found the app to be a valuable and accessible tool for stress management, with 67% completing at least 7 out of 10 modules, indicating good engagement and usability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot testing an app-based stress management intervention for cancer survivors. Børøsund, E., Varsi, C., Clark, MM., et al.[2022]

The AWAKE program, an 8-week app-based intervention for young adult cancer survivors, showed high retention and satisfaction rates, with participants finding the content relevant and beneficial for discussing their experiences positively.

While the study involved a small sample size (n=38 for AWAKE and n=18 for attention control), there were positive trends in hope and quality of life outcomes, suggesting that hope-based interventions could help young adults reorient their goals after cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Hope-Based Intervention to Address Disrupted Goal Pursuits and Quality of Life Among Young Adult Cancer Survivors. Berg, CJ., Vanderpool, RC., Getachew, B., et al.[2021]

The PRISM intervention significantly improved resilience and cancer-specific quality of life in adolescents and young adults with cancer, as evidenced by a 3.0 point increase in resilience scores and a 9.6 point increase in quality of life scores after 6 months.

Participants in the PRISM group experienced reduced psychological distress compared to those receiving usual care, with a notable decrease of 2.1 points in distress scores, and a lower incidence of depression at 6 months (6% in PRISM vs. 21% in usual care).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting resilience in adolescents and young adults with cancer: Results from the PRISM randomized controlled trial. Rosenberg, AR., Bradford, MC., McCauley, E., et al.[2022]

A study involving 23 adolescents and young adults with cancer showed that a smartphone medication reminder app was widely used, with most participants engaging with it at least once during the 8-week period.

Over half of the participants reported taking their medications right after receiving reminders, indicating that the app was perceived as easy to use and effective in promoting adherence to their medication regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a Smartphone Application for Prompting Oral Medication Adherence Among Adolescents and Young Adults With Cancer Wu, YP., Linder, LA., Kanokvimankul, P., et al.[2019]

Citations

1.

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 ( ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/35585525/

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 ...

3.

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 ...

4.

jpsmjournal.com

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

The “Promoting Resilience in Stress Management” (PRISM ...

After adjusting for baseline scores, PRISM was associated with improvements in all instruments: Resilience (+2.3, 95% CI 0.7, 4.0), quality of life (+6.3 (95% ...

5.

reporter.nih.gov

reporter.nih.gov/project-details/10895146

Project Details

Our proposed randomized controlled trial uses a novel, person-centered intervention designed to bolster patient-reported resilience, in turn improving ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10186689/

Protocol for the promoting resilience in stress management ...

Adolescents and young adults (AYAs) with cancer are at high risk of poor psychosocial outcomes, and evidence-based interventions designed to meet their ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03668223

Study Details | NCT03668223 | The PRISM Intervention: a ...

Multi-site randomized controlled trial testing the efficacy of the Promoting Resilience in Stress Management (PRISM) intervention among adolescents and young ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11322713/

Mobile App Promoting Resilience in Stress Management ...

Promoting resilience in adolescents and young adults with cancer: results from the PRISM randomized controlled trial. Cancer. 2018;124(19):3909–3917. doi ...

9.

cancer.gov

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

Promoting Resilience in Stress Management (PRISM) for ...

Participating in PRISM may improve resilience, distress, hope, and quality of life in young adults with cancer or desmoid tumor. Eligibility Criteria ...

10.

bmcpalliatcare.biomedcentral.com

bmcpalliatcare.biomedcentral.com/articles/10.1186/s12904-022-00966-9

The Promoting Resilience in Stress Management (PRISM ...

Promoting resilience in adolescents and young adults with cancer: results from the PRISM randomized controlled trial. Cancer. 2018;124(19): ...