Intervention to Enhance Quality of Life in Men with PCa: Development and Testing

描述（由申请人提供）：本拟议研究的目的是开发具有个体定制元素的靶向干预，并初步测试其对前列腺癌（PCa）相关身体症状、焦虑、抑郁症状、唾液皮质醇（心理困扰的生理指标）和生活质量（身体、功能和情感健康）的影响。参与者包括将接受近距离放射治疗（IMRT+HDR或IMRT+粒子植入）的男性，这是PCa增长最快的治疗方法，或根治性直肠癌切除术（RP），最常见的治疗方法。具体目标是：（1）对目前正在接受或已完成IMRT+HDR、IMRT+粒子植入或RP治疗的PCa男性进行焦点小组研究，（2）根据焦点小组数据开发一种增强疗效的自我护理干预措施，（3）对60名男性进行干预试验：干预组n=30，对照组n=30，（4）估计干预的效应量，（5）评估招募的可行性，损耗和报告的原因，数据收集点的数量，参与焦点小组，干预的保真度、对干预的坚持以及干预的扩散。三阶段重复测量实验设计，结合定性和定量方法。第1阶段：将举行焦点小组会议，以确定接受PCa治疗的男性使用的自我护理行为。第二阶段：在自我效能理论的指导下，将使用第一阶段的数据开发一种增强效能的自我护理干预。干预措施将包括：1）一个视频，将提供业绩成就的建模/可视化，面对面提供（第一次剂量）和个人DVD播放器，用于参与者选择的加强剂量，2）描述潜在自我护理行为的自我护理行为手册，以及3）目标设定和与干预者签订合同，以使用参与者选择的自我护理行为，和口头说服和干预者提供的症状体验的正常化。第三阶段：将对提高疗效的干预措施进行测试，并与注意力控制组进行比较。将在基线（受试者接受PCa治疗前）、干预后1个月和6个月收集数据。前列腺癌（PCa）是美国男性最常见的癌症。诊断和治疗的改进提高了存活率。然而，生存受到身体和心理症状的影响，导致生活质量差。建议的提高疗效的自我护理干预措施将解决这些症状，并有可能提高这一人群的生活质量

DESCRIPTION (provided by applicant): The intent of this proposed study is to develop a targeted intervention, with individually tailored elements, and pilot test its effects on prostate cancer (PCa) related physical symptoms, anxiety, depressive symptoms, salivary cortisol (a physiological indicator of psychological distress), and quality of life (physical, functional and emotional well-being). Participants include men who will receive brachytherapy (IMRT+HDR or IMRT+seed implantation), which is the fastest growing treatment for PCa, or radical prostatectomy (RP), the most common treatment. Specific aims are to (1) conduct focus groups with men currently undergoing or who completed treatment for PCa with IMRT+HDR, IMRT+seed implantation, or RP, (2) develop an efficacy-enhancing self-care intervention based on focus group data, (3) pilot the intervention with 60 men: n=30 in the intervention group and n=30 controls, (4) estimate effect size of the intervention, (5) assess feasibility of recruitment, attrition and reported causes, number of data collection points, participation in focus groups, fidelity of the intervention, adherence to the intervention, and diffusion of the intervention. The three-stage, repeated measures experimental design incorporates qualitative and quantitative methods. Stage 1: Focus groups will be held to determine self-care behaviors used by men undergoing treatment for PCa. Stage 2: An efficacy-enhancing self-care intervention, guided by self-efficacy theory, will be developed using Stage 1 data. The intervention will include: 1) a video which will provide modeling/ visualization of performance accomplishments, to be delivered face-to-face (first dose) and with personal DVD players for participant-selected booster doses, 2) a Self-care Behaviors booklet describing potential self-care behaviors, and 3) goal setting and contracting with the intervener for the use of participant-selected self-care behaviors, and verbal persuasion and normalization of the symptom experience provided by the intervener. Stage 3: The efficacy-enhancing intervention will be tested and compared with an attention control group. Data collection will occur at baseline (prior to participant's treatment for PCa), one and six months post-intervention. Prostate cancer (PCa) is the most common cancer in men in the United States. Improved diagnosis and treatment have led to increased survival rates. However, survival is marred by physical and psychological symptoms that result in poor quality of life. The proposed efficacy-enhancing self-care intervention will address these symptoms, and has the potential to improve the quality of life of this population