Improving Urinary Continence and Quality of Life in Prostate Cancer Patients

改善前列腺癌患者的尿失禁和生活质量

• 批准号: 7581948
• 负责人: Amy Y Zhang
• 金额: $ 78.53万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-01-01 至 2012-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7581948
• 关键词: Address; Adherence; Adverse effects; Aftercare; Behavior Therapy; Biofeedback; Bladder; Bladder Control; Cancer Patient; Cancer Survivor; Caring; Cessation of life; Clinical Trials; Computer Assisted; Cost Effectiveness Analysis; Data; Diagnosis; Drug Formulations; Economic Burden; Educational process of instructing; Effectiveness of Interventions; Evaluation; Exercise; Extravasation; Failure; Feeling; Funding; Goals; Group Meetings; Incidence; Incontinence; Individual; Intervention; Knowledge; Learning; Longitudinal Studies; Malignant Neoplasms; Malignant neoplasm of prostate; Measures; Mediating; Medical; Medical Economics; Mission; Moods; Motivation; Muscle; National Cancer Institute; Newly Diagnosed; Nurses; Operative Surgical Procedures; Outcome; Outcome Study; Participant; Patients; Pelvic Floor Muscle; Physiological; Pilot Projects; Prevalence; Problem Solving; Productivity; Prostate; Prostatectomy; Quality of life; Quality-Adjusted Life Years; Radical Prostatectomy; Randomized; Recovery; Recruitment Activity; Reporting; Research; Self Care; Self Efficacy; Self Management; Shame; Social support; Societies; Solutions; Sphincter; Staging; Support Groups; Symptoms; Techniques; Telephone; Testing; Training; United States; Universities; Upper arm; Urethra; Urinary Incontinence; Urodynamics; base; cancer care; cancer diagnosis; combat; computerized; cost; cost effectiveness; depressed; effective therapy; follow-up; group intervention; improved; intervention effect; intervention program; men; problem solving therapy; programs; public health relevance; skills; socioeconomics; standard care; treatment as usual; urinary

DESCRIPTION (provided by applicant): The National Cancer Institute set the Challenge Goal of eliminating cancer suffering and death by 2015. Improving cancer care and the quality of life for cancer survivors is a critical component of this mission. Despite a 93% rate of 10-year survival in patients with prostate cancer - the most common cancer diagnosis in men - incidence of urinary incontinence (UI) resulting from radical prostatectomy is reported to be as high as 87%. Thirty percent of prostate cancer patients remain incontinent one year after surgery, and according to the NCI-funded Prostate Outcome Study, 14% continue to leak five years later. Although evidence suggests that pelvic floor muscle exercises (PFME), combined with biofeedback training, significantly improves continence in the early months after prostatectomy, its effect on UI that persists for more than six months is inconclusive. Based on promising results from our pilot studies, we propose a "STAY DRY" intervention program that innovatively combines biofeedback PFME with a telephone or support group intervention to treat persistent UI. The study's primary aims are to improve continence, quality of life, and mood through enhancing adherence to PFME and self-management of bladder control. The secondary aims are to examine the physiological effects and cost effectiveness of the proposed interventions. This is a randomized, controlled longitudinal study. Three hundreds and twelve patients with early-stage prostate cancer and UI for more than six months will be randomly assigned to one of three study arms: (1) biofeedback PFME plus a support group (BF+GROUP); (2) biofeedback PFME plus telephone (BF+PHONE); and (3) usual care (UC). The BF+GROUP and BF+PHONE participants will learn PFME through computerized biofeedback. Thereafter, the BF+GROUP participants will attend six group meetings and the BF+PHONE participants will have six phone contacts every other week for three months. The interventions use a Problem-Solving Therapy (PST) framework to treat UI. The UC participants will not receive biofeedback PFME or telephone/group intervention but will continue receiving usual medical care. In addition, 51 moderately to severely incontinent patients will be recruited from the three study groups, with 17 per group, to undergo urodynamic testing at T1 and T2. Data of the costs for the interventions and the participants' medical care will be collected for a cost-effectiveness analysis. All participants will be assessed at baseline (T1), three months (T2), and six months (T3). Assessments will focus on (1) the study outcomes (UI, quality of life, and mood); (2) the intermediate outcomes (adherence to PFME and self-management); (3) the effect of mediating variables; (4) physiological outcomes; (5) cost-effectiveness; and (6) covariates that include demographic, socioeconomic, and medical variables. Urodynamic testing will provide preliminary physiological evidence of the intervention effect. A cost-effectiveness analysis will inform societal benefits over intervention costs. Overall, the study will contribute to the formulation of an effective solution to persistent UI and has the potential to change standard care and improve long-term follow-up care for prostate cancer survivors. PUBLIC HEALTH RELEVANCE: Despite a prevalence of urinary incontinence among post treatment prostate cancer patients, men who suffer from urinary incontinence and its embarrassing symptoms, i.e., involuntary urinary leakage, have few options to combat this debilitating problem. But that may soon change. A research team at Case Western Reserve University is proposing a study that uses computer-assisted biofeedback along with group and telephone-based therapy to hone preexisting techniques - the Kegel exercises - to bring relief to men suffering from urinary incontinence, ultimately helping them, as the title of the study program says, "STAY DRY."

描述（由申请人提供）：国家癌症研究所设定了消除2015年消除癌症痛苦和死亡的挑战目标。改善癌症护理和癌症幸存者的生活质量是该任务的关键组成部分。尽管前列腺癌患者的10年生存率为93％（男性最常见的癌症诊断），但据报道，从根治性前列腺切除术引起的尿失禁率（UI）高达87％。手术后一年中，有30％的前列腺癌患者仍在失禁，根据NCI资助的前列腺结局研究，五年后14％继续泄漏。尽管有证据表明，骨盆底肌肉运动（PFME）与生物反馈训练相结合，在前列腺切除术后的早期几个月中显着改善了持续性，但其对UI的影响持续了六个月以上，这是尚无定论的。基于我们的试点研究的有希望的结果，我们提出了一项“保持干燥”干预计划，该计划将生物反馈PFME与电话或支持小组干预进行了创新，以治疗持久性UI。该研究的主要目的是通过增强对PFME的依从性和对膀胱控制的自我管理来改善持续性，生活质量和情绪。次要目的是检查拟议干预措施的生理效果和成本效益。这是一项随机，受控的纵向研究。三百和十二例早期前列腺癌和UI患者将随机分配给三个研究组之一：（1）Biofeatback PFME加上支持组（BF+组）； （2）Biofeatback PFME加电话（BF+电话）； （3）通常的护理（UC）。 BF+组和BF+电话参与者将通过计算机化生物反馈学习PFME。此后，BF+小组参与者将参加六次小组会议，而BF+电话参与者将每隔一周与六个电话联系三个月。干预措施使用解决问题的疗法（PST）框架来治疗UI。 UC参与者将不会收到生物反馈PFME或电话/组干预，但会继续接受通常的医疗服务。此外，将从三个研究组中招募51例中度至严重失禁的患者，每组17例，以在T1和T2处进行尿动力学测试。将收集干预措施和参与者医疗服务的成本数据以进行成本效益分析。所有参与者将在基线（T1），三个月（T2）和六个月（T3）时进行评估。评估将重点放在（1）研究结果（UI，生活质量和情绪）上； （2）中间结果（遵守PFME和自我管理）； （3）介导变量的影响； （4）生理结果； （5）成本效益； （6）包括人口，社会经济和医学变量的协变量。尿动力测试将提供干预效果的初步生理证据。成本效益分析将为社会利益提供给干预成本的福利。总体而言，该研究将有助于制定有效的解决方案，以持续使用UI，并有可能改变标准护理并改善前列腺癌幸存者的长期后续护理。公共卫生相关性：尽管治疗后前列腺癌患者尿失禁患病率，但患有尿失禁及其令人尴尬症状的男性，即非自愿尿液泄漏，几乎没有选择来解决这个令人衰弱的问题。但这可能很快就会改变。 Case Western Reserve University的一项研究团队正在提出一项研究，该研究使用计算机辅助的生物反馈以及基于小组和电话的疗法来磨练先前存在的技术（Kegel练习），以使患有尿失禁的男性救济，最终帮助他们，正如该研究计划的标题所说：“保持干燥”。