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

Trial Summary

What is the purpose of this trial?

The goal of this pilot trial is to examine whether a mobile app version of the Promoting Resilience in Stress Management (PRISM) intervention is acceptable, easy to use, and helps improve quality of life and mental health symptoms.

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 data supports the effectiveness of the treatment mPRISM, PRISM, Promoting Resilience in Stress Management for teens and young adults with cancer?

Research shows that interventions like PRISM, which focus on building resilience, can improve resilience, quality of life, and reduce psychological distress in adolescents and young adults with cancer. Additionally, app-based cognitive-behavioral stress management interventions have been found to significantly decrease stress and anxiety, and improve quality of life in cancer survivors. ^{1 2 3 4 5}

How is the mPRISM treatment different from other treatments for cancer in teens and young adults?

The mPRISM treatment is unique because it focuses on building resilience and managing stress through a mobile app, which is designed specifically for teens and young adults with cancer. Unlike traditional treatments that may focus on physical symptoms, mPRISM aims to improve mental well-being and quality of life by enhancing resilience resources. ^{1 4 6 7 8}

Eligibility Criteria

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

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

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.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

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

Promoting resilience in adolescents and young adults with cancer: Results from the PRISM randomized controlled trial. [2022]

2. United States 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. [2023]

3. Canada pubmed.ncbi.nlm.nih.gov

Understanding Adolescent and Young Adult 6-Mercaptopurine Adherence and mHealth Engagement During Cancer Treatment: Protocol for Ecological Momentary Assessment. [2023]

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

Pilot testing an app-based stress management intervention for cancer survivors. [2022]

5. Switzerland 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. [2021]

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

The adolescent/young adult experience. [2019]

7. England pubmed.ncbi.nlm.nih.gov

A Hope-Based Intervention to Address Disrupted Goal Pursuits and Quality of Life Among Young Adult Cancer Survivors. [2021]

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

Use of a Smartphone Application for Prompting Oral Medication Adherence Among Adolescents and Young Adults With Cancer [2019]