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

项目总结 癌症存在许多有效的基于家庭的干预(FBI)，但很少被整合到常规护理中 因为它们没有以支持实施的方式设计/报告。障碍包括资源- 与临床工作流程不兼容的密集设计(例如多次面对面访问或电话会议 向照顾者提供的服务得不到医疗补偿。 调整传递渠道可以促进临床吸收，并改善结果，但几乎没有指导作用 存在用于调整基于面对面/电话的FBI以通过网络/移动平台递送的方法。这项研究使用了 实施科学(IS)和人机交互原理开发适应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接受度。我们将改编一个高度 前景看好的以电话为基础的联邦调查局呼叫Share(应对头部和颈部辐射的配偶) 对于通过移动网络交付(AIM 1)，评估新份额的可行性、可接受性和非劣势 2.0原型(AIM 2A)，并阐明可能影响实施SHARE 2.0(AIM 2B)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)，通过协作努力调整Share 6名HNC患者和6名护理人员就未适应的共享材料和所需的技术提供反馈 Share 2.0的功能，为适应蓝图提供参考。接下来，我们将加速创建应用到- 支持(ACTS)模型迭代开发Share 2.0，然后对5名患者和5名患者进行可用性测试 照顾者。结果将是一个没有重大可用性错误的功能原型。对于AIM 2A， 我们将进行一项SHARE 2.0的单臂试验，试验对象为65名患者和护理者。参与者完成调查 开始外照射(EBRT)前和EBRT后1个月。我们将判定这次审判是可行的。 如果结果与至少70%的符合条件的患者/照顾者登记和至少 80%的受访者表示对内容/物流感到满意。我们还将检查Share 2.0的表现是否与之相当 通过将本次试验的结果与最初的SHARE试点试验的结果进行比较来分享。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，以确定以下个人/组织因素 在迈向混合模式之前，可能会影响未来对Share 2.0的采用、实施和可持续性 实施--效果试验。总体而言，这项研究将产生一个有效的技术支持的干预 提供症状管理支持，并满足利益相关者的需求，从而最大限度地提高 肿瘤学临床护理中的摄取和可持续性。如果成功，它可以作为一个模型，以适应其他 FBI用于数字交付，并改善癌症患者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.