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

基本信息

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
项目类别：
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

项目摘要

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.

抽象的口服和口咽癌的诊断和治疗对吞咽，味觉，说话，咀嚼并保持头部，颈部和肩膀的运动。保留功能并延迟减少效果，幸存者协调其长期的医疗和社会心理需求，管理大量日常护理程序，并解决合并症。尽管长期生存护理要求，没有基于经验的干预措施来帮助幸存者建立技能和信心有效管理他们的护理。我们已经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注册表，并使用此反馈设计并测试了可行性和授权幸存者（ES）的初步疗效，这是一种创新且互动的在线干预措施。我们的结果表明有能力的幸存者被充分利用，并导致自我效能的显着提高管理护理，更大的准备生存以及头脑特定的生活质量（QOL）。参与三种自我保健行为（口腔自我检查，吞咽以及头部和颈部流动性练习）增加。拟议的研究的目的是通过增强模块来加强ES干预并根据参与者的意见添加两个模块：平静与连接，重点是管理心理问题和维护，重点是维持自我保健常规。我们将评估ES 反对免费的在线自我管理干预措施，超越癌症的跳板（跳板）国家癌症研究所和美国癌症协会为癌症幸存者开发。六百一到三年前完成治疗且目前无癌症的患者将是通过新泽西州癌症登记处或大加利福尼亚州的癌症注册中心招募并随机招募分配给ES或跳板。参与者将在基线，2和6个月后完成措施。基线。最后，我们将对有能力的幸存者进行流程评估，以告知未来执行。这项单位临床试验研究有四个目标。 AIM 1评估ES与自我效能感，准备性以及头颈部特定于QOL的主要结果。目标2 检查调解员（计划，信息需求，支持需求，激活，对复发的恐惧）和 ES对主持人（年龄，种族/种族，性别，性别，HPV状态，基线自我效能和准备）管理护理，准备和头颈特定QOL的自我效能。 AIM 3评估 ES与Springboard超越癌症，在口服自我检查的次要结果和头部和颈部活动性练习。探索目标对ES进行了过程评估，以告知未来执行。尽管癌症幸存者有许多长期的自我保健需求，但在经验上很少基于癌症幸存者的自我管理干预措施。应该授权幸存者有效，将成为各种癌症幸存者的护理模型，并推进科学和实践，特别是在社区获得照顾的幸存者。