Center for Child Health, Behavior and Development, Seattle Children's Research Institute, Seattle, WA, United States.
Department of Psychiatry & Behavioral Sciences, University of Washington School of Medicine, Seattle, WA, United States.
JMIR Res Protoc. 2024 Jul 30;13:e57950. doi: 10.2196/57950.
Adolescents and young adults (AYAs) with cancer are at risk of poor psychosocial outcomes. AYAs grew up with the internet and digital technology, and mobile Health (mHealth) psychosocial interventions have the potential to overcome care access barriers.
This pilot randomized controlled trial (RCT) aimed to establish the feasibility, acceptability, and preliminary efficacy of a fully automated mobile app version of the Promoting Resilience in Stress Management intervention (mPRISM). Promoting Resilience in Stress Management is an evidence-based intervention developed in collaboration with AYAs, based on stress and coping theory, resilience theory, and evidence-based coping strategies. We hypothesized that mPRISM would be feasible, acceptable, and appropriate.
This is a parallel, 2-arm, single-site pilot RCT with a waitlist control design. The study will recruit 80 AYAs with cancer from a clinic. Eligible AYAs are aged 12 to 25 years, within 12 months of a new cancer diagnosis, receiving chemotherapy or radiation therapy, speak, read, or write in English, and are cognitively able to participate in study procedures. Recruitment by clinical research coordinators will occur remotely by phone, video, or text. Participants will be randomized to psychosocial usual care (UC) alone or UC plus mPRISM for an 8-week intervention period, and will remain unblinded to study condition. Enrolled participants will complete surveys at baseline before randomization, 8 weeks, and 3-month follow-up. Using a waitlist design, the UC arm will receive mPRISM upon completion of 3-month follow-up surveys. Those in the UC arm will complete 2 additional measurement points at immediate posttreatment and 3 months later. The primary outcomes of interest are feasibility, defined as ≥60% enrollment and ≥70% retention (ie, percentage of participants who completed the study), and "feasibility, acceptability, and appropriateness" as defined by cut-off scores ≥4/5 on 3 brief validated implementation outcome measures (feasibility of implementation measure, acceptability of intervention measure [AIM], intervention appropriateness measure [IAM]). We will apply top-box scoring for the implementation measures. Exploratory outcomes of interest include patient-reported health-related quality of life, resilience, distress, anxiety, depression, pain, and sleep. We will conduct an intention-to-treat analysis to compare the outcomes of the mPRISM arm versus the control arm with covariate-adjusted regression models. We will summarize individual digital usage metrics using descriptive statistics.
Since September 2023, we have enrolled 20 participants and recruitment is ongoing.
Although our previous work suggests AYAs with cancer are interested in mHealth psychosocial interventions, 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. In this study, we will test the feasibility, acceptability, and preliminary efficacy of mPRISM. This work will inform future larger-scale RCTs powered for efficacy outcomes.
ClinicalTrials.gov NCT05842902; https://clinicaltrials.gov/study/NCT05842902.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/57950.
青少年和青年癌症患者（AYAs）面临着较差的心理社会结局的风险。AYAs 在互联网和数字技术中成长，移动健康（mHealth）心理社会干预有克服护理获取障碍的潜力。
本研究旨在通过与 AYA 合作开发的、基于压力和应对理论、韧性理论以及循证应对策略的基于证据的干预措施 Promoting Resilience in Stress Management（PRISM）的完全自动化移动应用程序版本，确定该试验的可行性、可接受性和初步疗效。我们假设 mPRISM 将是可行的、可接受的和合适的。
这是一项平行、2 臂、单站点的试点 RCT，采用等待对照设计。研究将从一个诊所招募 80 名患有癌症的 AYA。合格的 AYA 年龄在 12 至 25 岁之间，在新诊断癌症后 12 个月内，接受化疗或放疗，能说、读或写英语，且认知能力足以参与研究程序。临床研究协调员将通过电话、视频或短信进行远程招募。参与者将被随机分配到接受心理社会常规护理（UC）或 UC 加 mPRISM 的 8 周干预期，且保持对研究条件的非盲。入组的参与者将在随机分组前、8 周和 3 个月随访时完成调查。采用等待对照设计，UC 组将在完成 3 个月随访调查后接受 mPRISM。UC 组将在即时治疗后和 3 个月后再完成 2 次额外的测量点。主要关注的结局是可行性，定义为≥60%的入组率和≥70%的保留率（即完成研究的参与者百分比），以及通过 3 项简短的验证性实施结果测量（实施措施可行性、干预措施可接受性测量[ AIM]、干预措施适宜性测量[IAM]）的≥4/5 的“可行性、可接受性和适宜性”的得分。我们将对实施措施采用最高分评分。感兴趣的探索性结局包括患者报告的健康相关生活质量、韧性、困扰、焦虑、抑郁、疼痛和睡眠。我们将采用协变量调整的回归模型对 mPRISM 组与对照组的结果进行意向治疗分析。我们将使用描述性统计对个别数字使用指标进行总结。
自 2023 年 9 月以来，我们已经招募了 20 名参与者，且招募仍在进行中。
尽管我们之前的工作表明癌症青少年对 mHealth 心理社会干预感兴趣，但此类干预措施尚未在 AYA 肿瘤患者中得到充分评估或实施。mPRISM 可能成为一种潜在的 mHealth 干预措施，以填补这一空白。在这项研究中，我们将测试 mPRISM 的可行性、可接受性和初步疗效。这一工作将为未来的、针对疗效结果的更大规模 RCT 提供信息。
ClinicalTrials.gov NCT05842902；https://clinicaltrials.gov/study/NCT05842902。
国际注册报告标识符（IRRID）：DERR1-10.2196/57950。
