Adaptation and Evaluation of SHARE: A Palliative Care Intervention for Head and Neck Cancer Patients and their Caregivers

项目摘要 许多有效的以家庭为基础的干预（FBIs）存在于癌症，但很少有被纳入常规护理 因为它们的设计/报告方式不支持执行。障碍包括资源- 与临床工作流程不兼容的密集设计（例如，多次亲自访问或电话会议 与保健服务提供者）和缺乏对提供给照顾者的服务的保健报销。 调整输送通道可以促进临床吸收，改善结果，但指导很少 用于使基于个人/电话的FBI适于经由web/移动的平台递送。本研究采用 实施科学（IS）和人机交互原理，以开发适应FBIs的模型 用于数字交付，目标是提高肿瘤学临床护理环境中的使用率。我们将适应一个高度 有前途的电话为基础的联邦调查局称为共享（配偶应付头部和颈部辐射的经验） 对于通过移动的网络（AIM 1）递送，评价新SHARE的可行性、可接受性和非劣效性 2.0原型（AIM 2A），并阐明可能影响SHARE 2.0（AIM 2B）实施的因素。为 目标1，我们将通过组建利益相关者咨询委员会（SAC）， 6名HNC患者和6名护理人员提供关于不适用的SHARE材料和所需技术的反馈 共享2.0的功能，为适应蓝图提供信息。接下来，我们将应用加速创建- 支持（SHARE）模型，以迭代开发SHARE 2.0，然后对5名患者和5名 照顾者其结果将是一个功能原型，没有重大的可用性错误。对于AIM 2A， 我们将对65名患者-护理人员进行SHARE 2.0的单臂试验。参与者完成调查 开始外照射放射治疗（EBRT）前和EBRT后1个月。我们将判断审判可行 如果结果与至少70%的合格患者/护理人员入组一致，并且 80%的人对内容/物流表示满意。我们还将检查SHARE 2.0是否执行了 通过将本试验的结果与最初的SHARE试点试验的结果进行比较，对于AIM 2B，我们 将应用RE-AIM（覆盖范围、有效性、采用、实施、维护）QuEST（定性 系统翻译评估）混合方法框架，以确定 可能会影响SHARE 2.0未来的采用、实施和可持续性，然后再进行混合 实施效果试验。总的来说，这项研究将产生一个功能性的技术支持的干预措施， 提供企业管理支持，满足利益相关者的需求，从而最大限度地提高 肿瘤临床护理的吸收和可持续性。如果成功的话，它可以作为一个模型， FBIs用于数字交付并改善癌症的姑息和支持性护理交付。

PROJECT SUMMARY Many efficacious family-based interventions (FBIs) exist in cancer, but few have been integrated in routine care because they have not been designed/reported in a way that supports implementation. Barriers include resource- intensive designs that are incompatible with clinical workflows (e.g., multiple in-person visits or phone sessions with healthcare service providers) and a lack of healthcare reimbursement for services provided to caregivers. Making delivery channel adaptations could facilitate clinical uptake, and improve outcomes, but little guidance for adapting in-person/telephone-based FBIs for delivery via web/mobile platforms exists. This study uses Implementation Science (IS) and human-computer interaction principles to develop a model for adapting FBIs for digital delivery with the goal of improving uptake in oncology clinical care settings. We will adapt a highly promising telephone-based FBI called SHARE (Spouses coping with the Head and neck Radiation Experience) for delivery via mobile web (AIM 1), evaluate the feasibility, acceptability and non-inferiority of the new SHARE 2.0 prototype (AIM 2A), and elucidate factors that may influence implementation of SHARE 2.0 (AIM 2B). For AIM 1, we will adapt SHARE through collaborative efforts by assembling a stakeholder advisory committee (SAC) of 6 HNC patients and 6 caregivers to provide feedback on unadapted SHARE materials and desired technical features of SHARE 2.0 to inform an adaptation blueprint. Next, we will apply the Accelerated Creation-to- Sustainment (ACTS) model to iteratively develop SHARE 2.0 followed by usability testing with 5 patients and 5 caregivers. The outcome will be a functional prototype that is free from significant usability errors. For AIM 2A, we will conduct a single-arm trial of SHARE 2.0 with 65 patient-caregiver dyads. Participants complete surveys before initiating external beam radiation therapy (EBRT) and 1 month post-EBRT. We will judge the trial feasible and acceptable if results are consistent with at least 70% of eligible patients/caregivers enrolling and at least 80% reporting satisfaction with content/logistics. We will also examine whether SHARE 2.0 performs comparably to SHARE by comparing findings from this trial to the results of the original SHARE pilot trial. For AIM 2B, we will apply the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) QuEST (Qualitative Evaluation for Systematic Translation) mixed-methods framework to identify individual/organizational factors that may influence future adoption, implementation, and sustainability of SHARE 2.0 before proceeding to a hybrid implementation-effectiveness trial. Overall, this study will yield a functioning technology-enabled intervention that delivers symptom-management support, and meets the needs of stakeholders, thereby maximizing likelihood of uptake and sustainability in oncology clinical care. If successful, it could serve as a model for adapting other FBIs for digital delivery and improve palliative and supportive care delivery in cancer.