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

描述(申请人提供)：这项拟议研究的目的是开发一种有针对性的干预措施，包含个性化的元素，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(心理痛苦的生理指标)和生活质量(身体、功能和情绪健康)的影响。参与者包括将接受近距离放射治疗(调强放疗+HDR或调强放疗+粒子植入)的男性，这是前列腺癌增长最快的治疗方法，或根治性前列腺切除术(RP)，最常见的治疗方法。具体目标是(1)对正在接受或已经完成调强放疗+调强放射治疗、调强放疗+粒子植入或RP治疗的前列腺癌的男性进行焦点小组，(2)根据焦点组数据制定增强疗效的自我护理干预措施，(3)对60名男性进行干预试点，其中干预组30人，对照组30人，(4)估计干预措施的效果大小，(5)评估招募、减员和报告原因的可行性，数据收集点的数量，参与焦点小组的程度，干预措施的保真度，干预措施的坚持和传播。三阶段重复测量实验设计结合了定性和定量的方法。阶段1：将举行焦点小组，以确定接受前列腺癌治疗的男性使用的自我护理行为。第二阶段：将利用第一阶段的数据，在自我效能理论的指导下，开发一种增强疗效的自我护理干预措施。干预将包括：1)一段视频，将提供绩效成就的建模/可视化，将面对面地提供(第一剂)，并使用个人DVD播放机提供参与者选择的强化剂量；2)自我照顾行为手册，描述潜在的自我照顾行为；3)目标设定和与干预者签订使用参与者选择的自我照顾行为的合同，以及由干预者提供的症状体验的口头说服和正常化。阶段3：对增强效能的干预措施进行测试，并与注意控制组进行比较。数据收集将在基线(在参与者接受PCA治疗之前)、干预后1个月和6个月进行。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，这些症状导致生活质量低下。拟议的提高疗效的自我护理干预措施将解决这些症状，并有可能改善这些人群的生活质量。

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