Resilience Mobile App for Teens and Young Adults With Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: mPRISM.
- Who it may be relevant to
- Registry conditions: Cancer. Basic parameters: 12 years — 25 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pilot Trial Testing Mobile Health Psychosocial Intervention for Adolescents and Young Adults With Cancer
Overview
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.
Interventions
- Behavioral mPRISM
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 outcome measures
- Acceptability of intervention [Time frame: immediately post-intervention]
- Appropriateness of intervention [Time frame: immediately post-intervention]
- Feasibility of intervention [Time frame: immediately post-intervention]
Secondary outcome measures (5)
- 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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Seattle Children's Hospital — Seattle
Publications
- 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. PMID 39079108
Identifiers
NCT: NCT05842902 · STUDY00004006