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

NCT ID: NCT05842902Sponsor: Seattle Children's HospitalLast updated: 2025-07-20

Summary

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.

Detailed description

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.

Arms & interventions

  • BehavioralmPRISM

    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.

Outcome measures

Primary

  • Acceptability of 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.

    Time frame: immediately post-intervention

  • Appropriateness of 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.

    Time frame: immediately post-intervention

  • Feasibility of 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.

    Time frame: immediately post-intervention

Secondary

  • Usability of intervention

    Time frame: immediately post-intervention

  • Change in health-related quality of life

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

  • Change in resilience

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

  • Change in distress

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

  • Change in anxiety and depression

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

Eligibility criteria

Sex: AllAge: 12 Years to 25 YearsHealthy volunteers: No
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

Study locations (1)

Seattle Children's Hospital

Seattle, Washington, 98105

Recruiting
Nancy Lau, PhD · Contact
206-884-8238nancy.lau@seattlechildrens.org

References

  • Lau N, Palermo TM, Zhou C, Badillo I, Hong S, Aalfs H, Yi-Frazier JP, McCauley E, Chow EJ, Weiner BJ, Ben-Zeev D, Rosenberg AR. Mobile App Promoting Resilience in Stress Management for Adolescents and Young Adults With Cancer: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2024 Jul 30;13:e57950. doi: 10.2196/57950.(PubMed)
Resilience Mobile App for Teens and Young Adults With Cancer | Cancerify