RCT of an Online Multimedia Program to Boost Coping & Function for Pca Survivors

增强应对能力的在线多媒体项目的随机对照试验

• 批准号: 8475568
• 负责人: Suzanne M Miller
• 金额: $ 64.2万
• 依托单位: RESEARCH INST OF FOX CHASE CAN CTR
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-08-09 至 2016-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8475568
• 关键词: Address; Adverse effects; Aftercare; Behavioral; Cancer Control Research; Cancer Institute of New Jersey; Cancer Patient; Cancer Survivor; Cognitive; Collaborations; Communication; Computer software; Control Groups; Coping Skills; Data; Decision Making; Diagnosis; Emotional; Ensure; Environment; Exclusion; Family; Focus Groups; Fox Chase Cancer Center; Fright; Functional disorder; Funding; Health; Health Personnel; Healthcare; Institution; Intervention; Intestines; Literature; Malignant Neoplasms; Malignant neoplasm of prostate; Mediating; Mediator of activation protein; Medical; Medical center; Modeling; Monitor; Multimedia; Nature; Online Systems; Participant; Patients; Personal Satisfaction; Physical Function; Printing; Process; Quality of life; Radiation therapy; Radical Prostatectomy; Randomized Controlled Trials; Recruitment Activity; Recurrence; Research; Resources; Scanning; Science; Self Efficacy; Sexual Dysfunction; Social Problems; Software Design; Staging; Support System; Survivors; Symptoms; System; Testing; Text; Theoretical model; Treatment Efficacy; Voice; active method; animation; arm; base; coping; design; evidence base; experience; follow-up; group intervention; health care delivery; improved; information processing; innovation; intervention effect; intimate behavior; male; men; patient oriented; patient population; primary outcome; programs; prospective; psychologic; psychosocial; secondary outcome; skills training; social; software development; survivorship; theories; therapy development; treatment duration; treatment effect; urinary; usability; virtual

DESCRIPTION (provided by applicant): Following treatment, the vast majority of Pca survivors suffer from treatment-related symptomatology, specifically urinary and sexual dysfunction, in addition to facing psychosocial and practical challenges. There is a need for comprehensive programs with demonstrated efficacy to help patients cope with these challenges. We propose to develop and evaluate a comprehensive and innovative multimedia program designed to facilitate the post-treatment transition into survivorship. The design of the proposed intervention, the Virtual Survivorship Resource Center for Prostate Cancer (VSRC-PC), will be theoretically based on the team's Cognitive-Social Health Information Processing Model. The VSRC-PC will focus on promoting adaptive coping within four key post-treatment domains: 1) Physical Dysfunction (e.g., physical symptoms); 2) Emotional Well- Being (e.g., fear of recurrence); 3) Interpersonal Concerns (e.g., sexual intimacy issues); and 4) Practical Barriers (e.g., medical follow-up challenges). Content for these domains will be organized in a virtual resource center and will consist of: 1) provision of related information through text, graphics, voice-overs, and animation; 2) videos of health care experts answering frequently asked questions; 3) videos of prostate cancer survivors describing their experiences and modeling competencies and coping strategies; and 4) skills training to improve communication between Pca survivors and family and healthcare providers. Program content will be developed through literature and evidence-based content review, expert input, and input from multi-ethnic survivor focus groups. To ensure adequate and appropriate program content and optimal functionality, an iterative process of review, revision, and user and usability testing will be employed. Intervention efficacy will be evaluated through a two-arm, prospective randomized controlled trial. A total of 600 patients will complete the study. Data will be collected at baseline, and at 1-, 3- and 6- month follow-up. The primary outcome variable will be adaptive coping, and the secondary outcome will be maladaptive coping. A theory-based test of mediators of intervention effects (e.g., self-efficacy), and moderators (e.g., monitoring style) will also be performed. The proposed research will be the first RCT to evaluate not only a comprehensive but also highly disseminable and self-sustaining intervention for facilitating post-treatment adaptation among early-stage Pca survivors.

描述（由申请人提供）：治疗后，绝大多数PCA幸存者除了面临心理社会和实际挑战外，还患有治疗相关的泌尿系统疾病，特别是泌尿和性功能障碍。有必要提供具有证明疗效的综合方案，以帮助患者科普这些挑战。我们建议开发和评估一个全面且创新的多媒体程序，旨在促进治疗后向生存的过渡。拟议的干预措施的设计，前列腺癌虚拟生存资源中心（VSRC-PC），将在理论上基于该团队的认知社会健康信息处理模型。VSRC-PC将侧重于在四个关键的治疗后领域促进适应性应对：1）身体功能障碍（例如，身体症状）; 2）情绪健康（例如，害怕复发）; 3）人际关系（例如，性亲密问题）;以及4）实际障碍（例如，医疗后续挑战）。这些领域的内容将在一个虚拟资源中心中组织，包括：1）通过文本、图形、画外音和动画提供相关信息; 2）卫生保健专家回答常见问题的视频; 3）前列腺癌幸存者描述其经历和建模能力以及应对策略的视频; 4）技能培训，以改善PCA幸存者与家人和医疗服务提供者之间的沟通。计划内容将通过文献和循证内容审查、专家意见和多种族幸存者焦点小组的意见来制定。为确保充分和适当的程序内容和最佳功能，将采用审查、修订以及用户和可用性测试的迭代过程。将通过一项两组前瞻性随机对照试验评价干预疗效。共有600名患者将完成研究。将在基线以及1个月、3个月和6个月随访时收集数据。主要结果变量将是适应性应对，次要结果将是适应不良应对。基于理论的干预效应中介物测试（例如，自我效能），和调节者（例如，监测方式）也将执行。拟议的研究将是第一个随机对照试验，以评估不仅全面，而且高度传播和自我维持的干预措施，以促进早期PCA幸存者的治疗后适应。