PDF(Pubmed)
Abstract：
BACKGROUND: 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.
OBJECTIVE: 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.
METHODS: 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.
RESULTS: Since September 2023, we have enrolled 20 participants and recruitment is ongoing.
CONCLUSIONS: 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.
BACKGROUND: ClinicalTrials.gov NCT05842902; https://clinicaltrials.gov/study/NCT05842902.
UNASSIGNED: DERR1-10.2196/57950.
OBJECTIVE: 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.
METHODS: 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.
RESULTS: Since September 2023, we have enrolled 20 participants and recruitment is ongoing.
CONCLUSIONS: 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.
BACKGROUND: ClinicalTrials.gov NCT05842902; https://clinicaltrials.gov/study/NCT05842902.
UNASSIGNED: DERR1-10.2196/57950.
摘要：
背景：患有癌症的青少年和年轻人（AYAs）处于不良心理社会结果的风险中。随着互联网和数字技术的发展，和移动健康（mHealth）心理社会干预有可能克服护理障碍。
目的：本先导随机对照试验（RCT）旨在建立可行性，可接受性,以及在压力管理干预（mPRISM）中促进弹性的全自动移动应用程序版本的初步功效。促进压力管理中的弹性是与AYAs合作开发的基于证据的干预措施，基于压力和应对理论，韧性理论，和基于证据的应对策略。我们假设mPRISM是可行的，可接受,和适当的。
方法：这是并行的，双臂，具有等待列表控制设计的单站点飞行员RCT。该研究将从一家诊所招募80名患有癌症的AYAs。合资格的AYAs年龄在12至25岁之间，在新的癌症诊断后的12个月内，接受化疗或放疗，说话,阅读,或者用英语写，并且在认知上能够参与研究程序。临床研究协调员的招募将通过电话远程进行，视频,或文本。参与者将被随机分配到心理社会常规护理（UC）单独或UC加mPRISM，为期8周的干预期。并将保持对研究状况的了解。注册参与者将在随机化之前完成基线调查，8周,和3个月的随访。使用waitlist设计，UC部门将在完成3个月的跟踪调查后收到mPRISM。UC组的患者将在治疗后立即和3个月后完成2个额外的测量点。感兴趣的主要结果是可行性，定义为≥60%注册和≥70%保留(即，完成研究的参与者的百分比)，和“可行性”，可接受性,和适当性“定义为3项简短验证的实施结果措施的截止分数≥4/5(实施措施的可行性，干预措施的可接受性[AIM]，干预适当性措施[IAM])。我们将对实施措施应用机顶盒评分。感兴趣的探索性结果包括患者报告的健康相关生活质量，弹性，苦恼,焦虑,抑郁症,疼痛,和睡眠。我们将进行意向治疗分析，通过协变量调整回归模型比较mPRISM臂与对照臂的结果。我们将使用描述性统计来总结各个数字使用指标。
结果：自2023年9月以来，我们已经招募了20名参与者，并且正在进行招募。
结论：尽管我们之前的工作表明，患有癌症的AYAs对mHealth心理社会干预措施感兴趣，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可以作为潜在的mHealth干预措施来填补这一空白。在这项研究中,我们将测试可行性，可接受性,和mPRISM的初步疗效。这项工作将为未来更大规模的RCT提供有效的结果。
背景：ClinicalTrials.govNCT05842902;https://clinicaltrials.gov/study/NCT05842902。
■DERR1-10.2196/57950。
目的：本先导随机对照试验（RCT）旨在建立可行性，可接受性,以及在压力管理干预（mPRISM）中促进弹性的全自动移动应用程序版本的初步功效。促进压力管理中的弹性是与AYAs合作开发的基于证据的干预措施，基于压力和应对理论，韧性理论，和基于证据的应对策略。我们假设mPRISM是可行的，可接受,和适当的。
方法：这是并行的，双臂，具有等待列表控制设计的单站点飞行员RCT。该研究将从一家诊所招募80名患有癌症的AYAs。合资格的AYAs年龄在12至25岁之间，在新的癌症诊断后的12个月内，接受化疗或放疗，说话,阅读,或者用英语写，并且在认知上能够参与研究程序。临床研究协调员的招募将通过电话远程进行，视频,或文本。参与者将被随机分配到心理社会常规护理（UC）单独或UC加mPRISM，为期8周的干预期。并将保持对研究状况的了解。注册参与者将在随机化之前完成基线调查，8周,和3个月的随访。使用waitlist设计，UC部门将在完成3个月的跟踪调查后收到mPRISM。UC组的患者将在治疗后立即和3个月后完成2个额外的测量点。感兴趣的主要结果是可行性，定义为≥60%注册和≥70%保留(即，完成研究的参与者的百分比)，和“可行性”，可接受性,和适当性“定义为3项简短验证的实施结果措施的截止分数≥4/5(实施措施的可行性，干预措施的可接受性[AIM]，干预适当性措施[IAM])。我们将对实施措施应用机顶盒评分。感兴趣的探索性结果包括患者报告的健康相关生活质量，弹性，苦恼,焦虑,抑郁症,疼痛,和睡眠。我们将进行意向治疗分析，通过协变量调整回归模型比较mPRISM臂与对照臂的结果。我们将使用描述性统计来总结各个数字使用指标。
结果：自2023年9月以来，我们已经招募了20名参与者，并且正在进行招募。
结论：尽管我们之前的工作表明，患有癌症的AYAs对mHealth心理社会干预措施感兴趣，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可以作为潜在的mHealth干预措施来填补这一空白。在这项研究中,我们将测试可行性，可接受性,和mPRISM的初步疗效。这项工作将为未来更大规模的RCT提供有效的结果。
背景：ClinicalTrials.govNCT05842902;https://clinicaltrials.gov/study/NCT05842902。
■DERR1-10.2196/57950。
