RCT of an Online Multimedia Program to Boost Coping & Function for 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，还遭受与治疗相关的症状，特别是泌尿和性功能障碍。我们需要一个综合性的项目来证明其有效性，以帮助患者应对这些挑战。我们建议开发和评估一个全面和创新的多媒体程序，旨在促进治疗后过渡到幸存者。提出的干预措施，前列腺癌虚拟幸存者资源中心（VSRC-PC）的设计，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将侧重于在治疗后的四个关键领域促进适应性应对：1)身体功能障碍（如身体症状）；2)情绪健康（如害怕复发）；3)人际关系问题（如性亲密问题）；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组织，并将包括：1)通过文本、图形、画外音和动画提供相关信息；2)医疗专家回答常见问题的视频；3)前列腺癌幸存者的视频描述他们的经历和建模能力和应对策略；4)技能培训，以改善Pca幸存者与家人和医疗保健提供者之间的沟通。项目内容将通过文献和基于证据的内容审查、专家意见和多民族幸存者焦点小组的意见来发展。为了确保充分和适当的程序内容和最佳的功能，将采用评审、修订、用户和可用性测试的迭代过程。干预效果将通过两组前瞻性随机对照试验进行评估。总共有600名患者将完成这项研究。数据将在基线、1个月、3个月和6个月随访时收集。主要结果变量将是适应性应对，次要结果将是不适应应对。对干预效果的中介（如自我效能）和调节因子（如监控风格）也将进行基于理论的测试。拟议的研究将是第一个RCT，不仅评估全面的，而且高度传播和自我维持的干预措施，以促进早期前列腺癌幸存者的治疗后适应。

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.