The primary aim of this study is to evaluate the feasibility and acceptability of a self-guided mHealth resilience intervention (mPRISM) for AYAs with cancer. mPRISM content is based on stress and coping theory, resilience theory, and evidence-based psychosocial interventions. We hypothesize that mPRISM will be feasible as measured by ≥60% enrollment and ≥70% retention of participants to complete the study; and feasible, acceptable, and appropriate as measured by 3 brief well-established implementation measures (feasibility of intervention measure [FIM], acceptability of intervention measure [AIM], and intervention appropriateness measure [IAM] scores ≥4/5) [31]. Exploratory aims are to (1) examine preliminary efficacy assessed by validated patient-reported outcome measures at posttreatment and 3-month follow-up and (2) summarize digital usage metrics and engagement patterns under naturalistic conditions to inform future study design and to prepare participant instructions on how to use the app.

This is a parallel, 2-arm, pilot RCT (Figure 1) [32]. Participants (N=80) with cancer will be enrolled and randomized to usual care (UC) or UC plus mPRISM at a single site. Using a waitlist design, mPRISM will be provided to the UC arm at a 3-month follow-up. Participant randomization to the study arm will occur after the completion of baseline surveys and in a 1:1 allocation ratio. As a waitlist design is being used, it is not possible to blind participants to the intervention condition [33]. Study outcomes, however, are completed independently by AYA participants to minimize bias.

AYAs are eligible if they are (1) 12-25 years old; (2) within 12 months of diagnosis of new cancer; (3) receiving chemotherapy or radiation therapy at Seattle Children’s Hospital; (4) speak, read, or write English; and (5) have no cognitive limitations that would make participation difficult. We will provide iPads (Apple Inc) for the duration of the study for those who do not own a device.

Exclusion criteria include patient refusal to participate or parental refusal to participate for patients <18 years of age, patients who received a diagnosis of malignancy >12 months ago, patients with relapsed or refractory cancer, patients who have not received any chemotherapy or radiation therapy as part of their cancer treatment, cognitively or physically unable to participate, and previous participation in other PRISM-based studies. Clinical research coordinators will identify potential participants and prescreen through clinic rosters and electronic medical records. Recruitment by clinical research coordinators will occur remotely by phone, video, or SMS text messaging (ie, Zoom [Qumu Corp], Microsoft Teams, Webex [Cisco Systems], Skype [Microsoft Corp], email, SMS text messaging, and MyChart message [Epic Systems]).

All procedures are approved by the Seattle Children’s Hospital Institutional Review Board (STUDY00004006). The trial is registered at ClinicalTrials.gov (NCT05842902). All participants will provide informed consent (18-25 years old) or assent with parental consent (12-17 years old). Study participation is completely voluntary and participants are allowed to opt out of the study at any time. Privacy and confidentiality protections will be in accordance with institutional ethical guidelines. Study data are collected on secure, internal, HIPAA-compliant REDCap servers only accessible to the study team [34,35]. The collection of identifiable information is limited to that required to contact participants for study procedures and to report on sample demographics. Participants consented to use of data for study publications and no individually identifiable information will be reported in study publications. Participants will be compensated US $25 in electronic gift cards for completing each survey.

The World Health Organization states that digital and mHealth technologies have the potential to revolutionize health care and improve access to services [54]. mHealth interventions provide (1) in-the-moment support in patients’ day-to-day lives, (2) have been proven to be cost-effective due to reduced personnel and infrastructure requirements [55], and (3) have the ability to reach patients in remote areas and those traditionally underserved. Although there are 325,000 health-related apps available for download as of 2017 and a growth rate of 25% year-to-year [56], there are no evidence-based psychosocial mHealth interventions for AYAs with cancer. This pilot RCT is designed to evaluate the feasibility and acceptability of the mPRISM intervention, a skills-based mobile app adapted from the in-person PRISM program. This ongoing trial takes a critical next step in translating evidence-based interventions to digital platforms, expanding the reach of evidence-based supportive care to the vulnerable populations who need them. We anticipate that mPRISM will be feasible, acceptable, and appropriate. Exploratory patient-reported outcomes will inform sample size for future powered trials. Individual backend user data will explore patterns of engagement with skills modules. We expect findings from this pilot trial to inform the testing of mPRISM in a larger scale multisite hybrid effectiveness-implementation RCT powered for efficacy outcomes.

This study has several anticipated challenges. First, this is a single-site pilot trial, which may limit the generalizability of findings. However, the strengths of this single-site study are established relationships with the clinic to ensure project completion and preliminary data for future scale-up initiatives. Second, it is possible that we may have higher attrition rates and lower adherence, which is common in smartphone-based mental health interventions [57]. However, members of our research team have over a decade of experience and background with digital behavioral health interventions in research settings that have demonstrated low attrition and high adherence rates. We will monitor attrition rates on a monthly basis. If attrition is >50%, we will increase the level of study coordinator contact to ensure project completion. This will provide information on potential behavioral nudge strategies to increase engagement and sustainability. Third, we are primarily using remote recruitment methods, which may lead to higher or lower recruitment rates than expected. Fourth, we do not provide instructions to participants on how to engage with mPRISM, although a recommended order of module completion is available on the home screen based on the in-person version of the intervention. Digital usage metrics will inform future study design and the potential development of more structured instructions on how best to engage with mPRISM. Fifth, participants are not blinded to intervention conditions, which is a potential source of bias. Here, we evaluate the additive value of mPRISM to UC which is the standard of care all patients receive. Sixth, this is a feasibility waitlist control trial design, which limits our ability to make causal inferences regarding efficacy. Nonetheless, we will examine exploratory trends of symptom change. Future larger-scale studies will incorporate active treatment comparison conditions (eg, another behavioral health app) and be sufficiently powered for efficacy. In addition, future studies will test and refine implementation strategies in multisite clinical settings and include adaptations for other languages, cultures, and patient groups.

AYAs with cancer are a vulnerable population with unmet psychosocial needs. mHealth initiatives have the unique potential to scale up interventions and overcome structural barriers and unequal access to psychosocial treatment. Although our previous work suggests AYAs with cancer are interested in mHealth psychosocial interventions to improve QoL, resilience, and distress [58,59], such interventions have not yet been sufficiently evaluated or implemented among AYA oncology patients. mPRISM may serve as a potential mHealth intervention to fill this gap. This pilot trial will inform the necessary sample sizes and power of a future larger multisite hybrid effectiveness-implementation trial. Future studies will assess barriers and facilitators to mHealth psychosocial intervention adoption and maintenance, and strategies to increase and maintain mobile app engagement. This pilot study and future studies building on this work aim to expand the reach, adoption, and sustainability of evidence-based mHealth psychosocial interventions. Since the COVID-19 pandemic, digitally deployed supportive care has rapidly evolved and accelerated in research and practice settings [60]. This study has important clinical implications in the use of mHealth for psychosocial symptom self-management, exploring the potential integration of digital tools with psychosocial standard of care practices, and increasing access to care for underresourced groups.