Enhancing Self Care Among Oral Cancer Survivors: The Empowered Survivor Trial

增强口腔癌幸存者的自我护理：赋权幸存者试验

• 批准号: 10347328
• 负责人: Sharon L Manne
• 金额: $ 61.33万
• 依托单位: RBHS -CANCER INSTITUTE OF NEW JERSEY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-03-15 至 2023-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10347328
• 关键词: Address; Adherence; Affect; Alcohols; American Cancer Society; Appearance; Appointment; Attention; Behavior; California; Cancer Intervention; Cancer Survivor; Caring; Cessation of life; Clinical Trials; Communities; Complex; Deglutition; Dental Care; Dentists; Deterioration; Diagnosis; Disease; Electronic Mail; Ethnic Origin; Exercise; Feedback; Free Will; Fright; General Population; Goals; Head Movements; Head and neck structure; Human Papillomavirus; Intervention; Late Effects; Lesion; Life; Location; Long Term Survivorship; Long-Term Effects; Longterm Follow-up; Maintenance; Malignant Neoplasms; Measures; Mediation; Mediator of activation protein; Medical; Modeling; National Cancer Institute; Neck; New Jersey; Nutrition management; Oncologist; Oral; Oral cavity; Oral health; Participant; Patients; Performance; Pilot Projects; Positron-Emission Tomography; Prevalence; Quality of life; Race; Randomized; Readiness; Recurrence; Regimen; Reporting; Role; Science; Self Care; Self Efficacy; Self Management; Shoulder; Speech; Structure; Surgeon; Survivors; Symptoms; Taste Perception; United States; Xerostomia; advanced disease; base; cancer type; clinical research site; community setting; comorbidity; design; drinking; empowered; feasibility testing; follow-up; future implementation; health related quality of life; improved; innovation; loss of function; malignant mouth neoplasm; malignant oropharynx neoplasm; muscle strength; neoplasm registry; nutrition; online delivery; online intervention; oral care; physical therapist; preservation; prevent; primary outcome; process evaluation; psychologic; psychosocial; reconstruction; recruit; routine care; secondary outcome; sex; skills; smoking cessation; survivorship; symptom management

Abstract The diagnosis and treatment of oral and oropharyngeal cancers adversely affects the ability to swallow, taste, speak, chew, and maintain movement of the head, neck, and shoulder. To preserve function and reduce late effects, survivors coordinate their long-term medical and psychosocial needs, manage a significant number of daily care routines, and address comorbidities. Despite the significant long-term survivorship care requirements, there are no empirically-based interventions to assist survivors in building skills and confidence to effectively manage their care. We have evaluated the information and support needs of survivors recruited via the New Jersey State Cancer Registry and, using this feedback, designed, and tested the feasibility and preliminary efficacy of Empowered Survivor (ES), an innovative and interactive online intervention. Our results indicated that Empowered Survivor was well-utilized and resulted in significant improvements in self-efficacy in managing care, greater preparedness for managing survivorship, and head and neck specific quality of life (QOL). Engagement in three self-care behaviors (oral self-exam, swallowing and head and neck mobility exercises) increased. The goal of the proposed study is to bolster the ES intervention by enhancing modules and adding two modules based on participant input: Calm and Connect, which focuses on managing psychological concerns, and Maintaining, which focuses on maintaining self-care routines. We will evaluate ES against a free online self-management intervention, Springboard Beyond Cancer (Springboard), which was developed for cancer survivors by the National Cancer Institute and the American Cancer Society. Six hundred patients who have completed treatment between one and three years ago and are currently cancer-free will be recruited via the New Jersey State Cancer Registry or the Cancer Registry of Greater California and randomly assigned to ES or Springboard. Participants will complete measures at baseline, 2, and 6-months post- baseline. Finally, we will engage in a process evaluation of Empowered Survivor to inform future implementation. This single site clinical trial study has four aims. Aim 1 evaluates the impact of ES versus Springboard on the primary outcomes of self-efficacy, preparedness, and head and neck specific QOL. Aim 2 examines mediators (planning, information needs, support needs, activation, fear of recurrence) and moderators (age, race/ethnicity, sex, HPV status, baseline self-efficacy and preparedness) of ES's impact on self-efficacy in managing care, preparedness, and head and neck specific QOL. Aim 3 evaluate the impact of ES versus Springboard Beyond Cancer on the secondary outcomes of engagement in oral self-exams and head and neck mobility exercises. The Exploratory Aim conducts a process evaluation of ES to inform future implementation. Although cancer survivors have many long-term self-care needs, there are few empirically- based self-management interventions for cancer survivors. Should Empowered Survivor prove efficacious, it will serve as a model of care and advance both science and practice for survivors of all types of cancer, particularly survivors who receive their care in the community.

摘要 口腔和口咽癌的诊断和治疗对吞咽、味觉和 说话，咀嚼，并保持头部、颈部和肩部的运动。保功能、减迟滞 影响，幸存者协调他们的长期医疗和心理社会需求，管理相当数量的 日常护理，解决合并症。尽管有重要的长期生存护理 根据需求，没有基于经验的干预措施来帮助幸存者建立技能和信心 以有效地管理他们的护理。我们评估了招募的幸存者的信息和支助需求 通过新泽西州癌症登记处，并使用此反馈，设计并测试了可行性和 赋权幸存者(ES)的初步疗效，这是一种创新和互动的在线干预措施。我们的结果 表明赋能幸存者得到了很好的利用，并导致了自我效能的显著提高 管理护理，更好地准备管理生存，以及头和颈部特定的生活质量 (QOL)。参与三种自我护理行为(口腔自检、吞咽和头颈活动 练习)增加。拟议研究的目标是通过加强模块来支持ES干预 并根据参与者的输入增加了两个模块：Calm和Connect，重点是管理 心理关注和维护，重点是维护自我照顾的日常生活。我们将评估ES 反对免费的在线自我管理干预，跳板超越癌症(Springboard)，它是 由国家癌症研究所和美国癌症协会为癌症幸存者开发的。六百 在一年至三年前完成治疗并目前无癌症的患者将被 通过新泽西州癌症登记处或大加州癌症登记处招募，并随机 分配给ES或Springboard。参与者将在基线、2个月和6个月后完成测量 基线。最后，我们将对赋能幸存者进行流程评估，以告知未来 实施。这项单一地点的临床试验研究有四个目标。目标1评估ES的影响与 跳板的主要结果的自我效能，准备，和头和颈部的具体生活质量。目标2 审查调解人(规划、信息需求、支持需求、激活、担心复发)和 ES影响的调节因素(年龄、种族/民族、性别、HPV状态、基线自我效能和准备情况) 在管理护理、准备和头颈部特定生活质量方面的自我效能。目标3评估以下项目的影响 ES与超越癌症跳板在参与口试和自查的次要结果上的比较 头部和颈部活动练习。探索性目标是对专家系统进行过程评估，以供将来参考 实施。尽管癌症幸存者有许多长期的自我护理需求，但从经验上看却很少- 针对癌症幸存者的自我管理干预。如果被赋权的幸存者被证明是有效的，它 将成为所有类型癌症幸存者的护理和促进科学和实践的典范， 特别是在社区接受照顾的幸存者。