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: 10576315
• 负责人: Sharon L Manne
• 金额: $ 59.31万
• 依托单位: RUTGERS BIOMEDICAL AND HEALTH SCIENCES
• 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 2025-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10576315
• 关键词: Address; Adherence; Affect; Age; 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; Early Diagnosis; 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; Managed Care; Measures; Mediation; Mediator; Medical; Modeling; National Cancer Institute; Neck; New Jersey; Oncologist; Oral; Oral cavity; Oral health; Participant; Patients; Performance; Pilot Projects; Positron-Emission Tomography; Prevalence; Quality of life; Race; Randomized; Readiness; Recommendation; Recurrence; Regimen; Reporting; Role; Science; Self Care; Self Efficacy; Self Management; Shoulder; Speech; Structure; Surgeon; Survivors; Symptoms; Taste Perception; United States; Xerostomia; advanced disease; cancer type; clinical research site; community setting; comorbidity; design; drinking; empowerment; 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; 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 口腔癌和口咽癌的诊断和治疗对吞咽、味觉、 说话，咀嚼，保持头部，颈部和肩部的运动。保留功能并减少晚期 幸存者协调他们的长期医疗和心理需求，管理大量的 日常护理程序，并解决合并症。尽管长期的生存护理 根据要求，没有基于技能的干预措施来帮助幸存者建立技能和信心。 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持需求 通过新泽西州癌症登记处，并利用这些反馈，设计和测试了可行性， 授权幸存者（ES）的初步疗效，这是一种创新的互动式在线干预。我们的结果 表明，授权幸存者得到了很好的利用，并导致自我效能的显着改善， 管理护理，为管理生存率做好更充分的准备，以及头颈部特定的生活质量 （QOL）。参与三种自我护理行为（口腔自我检查、吞咽和头颈部活动 练习）增加。拟议研究的目标是通过加强模块来加强ES干预 并根据参与者的输入增加了两个模块：平静和连接，重点是管理 心理问题，以及维持，重点是维持自我护理程序。我们将评估ES 反对一个免费的在线自我管理干预，超越癌症的跳板（跳板），这是 由国家癌症研究所和美国癌症协会为癌症幸存者开发。六百 在一至三年前完成治疗且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 分配到ES或跳板。参与者将在基线、术后2个月和6个月完成测量， 基线。最后，我们将对增强幸存者的过程进行评估，以告知未来 实施.这项单中心临床试验研究有四个目的。目标1评价环境服务的影响， 自我效能、准备和头颈部特异性QOL主要结局的跳板。目的2 检查调解人（规划、信息需求、支持需求、激活、对再次发生的恐惧）和 ES影响的调节因素（年龄、人种/种族、性别、HPV状态、基线自我效能和准备） 管理护理、准备和头颈部特定QOL的自我效能。目标3：评估 ES与Springboard Beyond Cancer在参与口腔自我检查的次要结局上的比较， 头部和颈部活动练习。探索性目标进行ES的过程评估，以告知未来 实施.虽然癌症幸存者有许多长期的自我护理需求，但经验上很少- 为癌症幸存者提供自我管理干预。如果增强幸存者证明有效，它 将作为一种护理模式，推动科学和实践，为所有类型的癌症幸存者， 特别是在社区接受照顾的幸存者。