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.

项目摘要 癌症中存在许多有效的家庭干预措施（FBI），但很少有常规护理中纳入 因为它们没有以支持实施的方式设计/报告。障碍包括资源 - 与临床工作流不兼容的密集设计（例如，多次面对访问或电话会议 在医疗保健服务提供商中），缺乏​​提供给护理人员的服务的医疗保健报销。 进行交付渠道适应可以促进临床吸收，并改善结果，但很少的指导 为了适应基于人电/电话的FBI通过Web/Mobile Platform进行交付。这项研究使用 实施科学（IS）和人类计算机互动原则，以开发适应FBI的模型 用于数字交付，目的是改善肿瘤学临床护理环境的吸收。我们将适应一个高度的 有希望的基于电话的FBI称为共享（配偶应对头部和颈部辐射体验） 要通过移动网络交付（AIM 1），请评估新份额的可行性，可接受性和不效率 2.0原型（AIM 2A），并阐明可能影响股份实施的因素2.0（AIM 2B）。为了 AIM 1，我们将通过合作努力来调整分享通过组成利益相关者咨询委员会（SAC） 在6名HNC患者和6位护理人员中，提供了有关非适应性共享材料和所需技术的反馈 Share 2.0的功能可为改编蓝图提供信息。接下来，我们将应用加速的创建到 维持（ACT）模型以迭代开发股份2.0，然后对5例患者和5例进行可用性测试 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名患者护理人员二元组进行股份2.0的单臂试验。参与者完成调查 在启动外束辐射疗法（EBRT）和EBRT后1个月之前。我们将判断审判可行 如果结果与至少有70％的合格患者/护理人员入学和至少一致的结果是可以接受的 80％的报告对内容/物流的满意度。我们还将检查共享2.0是否表现相当 通过将该试验的发现与原始股票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（触及，有效性，采用，实施，维护）任务（定性 评估系统翻译）混合方法框架，以识别个人/组织因素 在进行混合动力之前，可能会影响股份2.0的未来采用，实施和可持续性 实施效率试验。总体而言，这项研究将产生功能正常的技术干预措施 提供症状管理支持，并满足利益相关者的需求，从而最大程度地提高 肿瘤学临床护理中的吸收和可持续性。如果成功，它可以作为适应其他人的模型 FBI用于数字交付并改善癌症中的姑息治疗和支持性护理。