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NCT Number: NCT05842902

Resilience Mobile App for Teens and Young Adults With Cancer

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.

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Key information

Conditions

Cancer Neoplasms

Age range

12 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location status: Recruiting

Location contact

Nancy Lau, PhD

CONTACT

[email protected]

206-884-8238

About this study

Adolescents and Young Adults (AYAs) with cancer are at risk of distress, anxiety, depression, and poor quality of life. The use of mobile applications for psychosocial symptom self-management is appealing to this demographic population but this has not yet been developed and tested.

PRISM is a novel, brief, evidence-based 1:1 intervention that teaches stress management, goal-setting, meaning making, cognitive-behavioral, and mindfulness strategies. Here, we propose to test a mobile health (mHealth) version of PRISM, mPRISM. In a pilot randomized controlled trial, we will evaluate the feasibility, acceptability, and exploratory efficacy of mPRISM using a waitlist control design.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 12-25 years
  • Diagnosis of new malignancy within 12 months of enrollment treated with chemotherapy and/or radiation therapy at Seattle Children's Hospital (SCH)
  • Patient able to speak/read/write English or Spanish language
  • Cognitively able to participate in mHealth psychosocial intervention and interactive interviews

Exclusion criteria

  • Patient refusal to participate (any age), or parental refusal to participate for patients less than 18 years of age
  • Patients with diagnosis of malignancy >12 months
  • Patients with relapsed, recurrent, or refractory disease
  • Patient without chemotherapy and/or radiation therapy as part of cancer treatment (e.g., surgical resection only patients are not-eligible)
  • Cognitively or physically unable to participate in mHealth psychosocial intervention and surveys

Treatment and study plan

mPRISM

Behavioral

PRISM is a brief, 1:1, skills-based resilience intervention delivered in-person by trained layperson coaches. PRISM's development was based on iterative research within the AYA oncology population, stress and coping theory, resilience theory, and successful cognitive-behavioral and mindfulness interventions. mPRISM is a digital version of the PRISM program with no in-person delivery. mPRISM includes coping skills modules: managing stress, goal-setting, cognitive reframing, and meaning-making.

Primary outcomes

  1. Acceptability of intervention

    Time frame: immediately post-intervention

    The Acceptability of Intervention Measure (AIM) is a well-validated 4-item scale that measures the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory. Scale ranges from 4 to 20; higher scores are better.

  2. Appropriateness of intervention

    Time frame: immediately post-intervention

    The Intervention Appropriateness Measure (IAM) is a well-validated 4-item scale that measures the perceived fit, relevance, or compatibility of the innovation or evidence-based practice for a given practice setting, provider, or consumer, and/or perceived fit of the innovation to address a particular issue or problem. Scale ranges from 4 to 20; higher scores are better.

  3. Feasibility of intervention

    Time frame: immediately post-intervention

    The Feasibility of Intervention Measure (FIM) is a well-validated 4-item scale that measures the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. Scale ranges from 4 to 20; higher scores are better.

Secondary outcomes

  1. Usability of intervention

    Time frame: immediately post-intervention

    The System Usability Scale (SUS) is a well-validated and widely used 10-item scale to evaluate the perceived usability of digital interventions. Items are rated on a 5-point Likert scale for a total score ranging from 0-100, and scores ≥70 considered adequate usability.

  2. Change in health-related quality of life

    Time frame: immediately post-intervention, 3 months post-intervention

    The PedsQL 4.0 Generic and 3.0 Cancer Module include 50 items evaluating health-related quality of life (HRQOL) of AYAs with cancer. Queries assess physical, emotional, social, and school well-being, plus cancer-related pain and hurt, nausea, procedural anxiety, treatment anxiety, worry, cognitive problems, perceived physical appearance, and communication. Scores are linearly transformed to a 0-100 scale, with higher scores indicating better HRQOL.

  3. Change in resilience

    Time frame: immediately post-intervention, 3 months post-intervention

    The CD-RISC is a well-validated and widely used 10-item instrument to measure inherent resiliency. Questions revolve around personal problem-solving and approaches to adversity. Scores range from 0-40, with higher scores indicating higher resilience.

  4. Change in distress

    Time frame: immediately post-intervention, 3 months post-intervention

    This 6-item scale measures "level of psychological distress experienced in the past month." The instrument strongly discriminates between community cases and non-cases of Diagnostic and Statistical Manual of Mental Disorder (DSM)-V psychiatric disorders such as serious emotional distress or serious mental illness. Scores range from 0-24, with higher scores indicating higher distress.

  5. Change in anxiety and depression

    Time frame: immediately post-intervention, 3 months post-intervention

    7 items assess symptoms of anxiety and depression, respectively, in patients with serious illness. It has been validated in AYAs with chronic illness and cancer survivors, with excellent reliability (α=0.83-0.82). Items are scored 0-3 (subscale range 0-21), with scores ≥8 categorized as borderline abnormal, and ≥11 categorized as abnormal.

Study contacts

Contact information is provided by the study sponsor or research team.

Nancy Lau, PhD

CONTACT

[email protected]

206-884-0569

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Collaborators

  • University of Washington

Registry information

Official study title

Pilot Trial Testing Mobile Health Psychosocial Intervention for Adolescents and Young Adults With Cancer

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
May 6, 2023
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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