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

SHARE 的适应和评估：针对头颈癌患者及其护理人员的姑息治疗干预措施

• 批准号: 10216592
• 负责人: Hoda J Badr
• 金额: $ 28万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-23 至 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10216592
• 关键词: Address; Adoption; Adult; Advisory Committees; Affect; Cancer Patient; Caregivers; Clinical; Clinical Oncology; Dehydration; Distress; Educational process of instructing; Enrollment; Equipment and supply inventories; Evaluation; External Beam Radiation Therapy; Family; Family member; Feedback; Focus Groups; Future; Goals; Head and Neck Cancer; Head and neck structure; Health Personnel; Healthcare; Hospital Costs; Impairment; Individual; Internet; Interruption; Intervention; Interview; Knowledge; Logistics; Malignant Neoplasms; Malnutrition; Manuals; Measures; Medical Care Team; Mental Health; Methods; Modeling; Nature; Nurses; Online Systems; Outcome; Pain; Palliative Care; Participant; Patients; Persons; Provider; Qualitative Evaluations; Quality of life; Radiation; Radiation therapy; Randomized; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Reporting; Resources; Self Care; Self Management; Services; Social Workers; Speech; Spouse Caregiver; Spouses; Supportive care; Surveys; Symptoms; System; Technology; Telephone; Testing; Time; Training and Education; Translations; Visit; acceptability and feasibility; arm; base; care coordination; care delivery; caregiver depression; caregiving; clinical care; computer human interaction; coping; design; digital delivery; digital intervention; effectiveness implementation study; effectiveness implementation trial; effectiveness trial; experience; feasibility trial; follow-up; head and neck cancer patient; health care service; implementation science; improved; improved outcome; informal caregiver; insight; mobile computing; pilot trial; post intervention; programs; prototype; routine care; satisfaction; service providers; side effect; skills training; symptom management; treatment as usual; uptake; usability

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.

项目概要 许多有效的基于家庭的干预措施 (FBI) 存在于癌症治疗中，但很少被纳入日常护理中 因为它们的设计/报告方式并未支持实施。障碍包括资源- 与临床工作流程不兼容的密集设计（例如，多次亲自就诊或电话会议 与医疗保健服务提供者）以及缺乏向护理人员提供的服务的医疗保健报销。 调整输送渠道可以促进临床应用并改善结果，但指导很少 现有用于调整面对面/基于电话的 FBI 以便通过网络/移动平台进行交付的方法。本研究使用 实施科学 (IS) 和人机交互原理，用于开发适应 FBI 的模型 用于数字化交付，旨在提高肿瘤临床护理环境的采用率。我们将采用高度 有前途的基于电话的联邦调查局称为SHARE（配偶应对头颈辐射经历） 通过移动网络交付（AIM 1），评估新 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 实施的因素（AIM 2B）。为了 目标 1，我们将通过组建利益相关者咨询委员会 (SAC) 的协作努力来调整 SHARE 6 名 HNC 患者和 6 名护理人员提供有关未改编的 SHARE 材料和所需技术的反馈 SHARE 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- 维持 (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， 我们将对 65 名患者-护理人员进行单组 SHARE 2.0 试验。参与者完成调查 开始外照射放射治疗 (EBRT) 之前和 EBRT 后 1 个月。我们将判断试验是否可行 如果结果与至少 70% 的合格患者/护理人员注册一致并且至少是可接受的 80% 的人对内容/后勤表示满意。我们还将检验 SHARE 2.0 的表现是否具有可比性 通过将该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（范围、有效性、采用、实施、维护）QuEST（定性 系统翻译评估）混合方法框架来识别个人/组织因素 在进行混合之前可能会影响 SHARE 2.0 未来的采用、实施和可持续性 实施效果试验。总体而言，这项研究将产生一种有效的技术干预措施， 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 肿瘤临床护理的吸收和可持续性。如果成功的话，它可以作为适应其他 FBI 用于数字化交付并改善癌症的姑息治疗和支持性护理服务。