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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：
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
项目类别：
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

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.

摘要