Improving Quality of Life of Prostate Cancer Survivors with Androgen Deficiency

改善雄激素缺乏的前列腺癌幸存者的生活质量

• 批准号: 10782755
• 负责人: SHALENDER BHASIN
• 金额: $ 44.73万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-01 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10782755
• 关键词: Adverse event; Aerobic; Affective; Androgens; COVID-19 pandemic; Cardiovascular system; Clinical Research; Clinical Trials Data Monitoring Committees; Consultations; Cost Savings; Disease; Distress; Double-Blind Method; Eligibility Determination; Enrollment; Equilibrium; Evaluation; Fatigue; Functional disorder; Funding; Gleason Grade for Prostate Cancer; Goals; Guidelines; Hematocrit procedure; Human Resources; Institution; Investments; Laboratories; Lifting; Lipids; Localized Disease; Malignant neoplasm of prostate; Medical; Monitor; Organ; Participant; Patient Self-Report; Personal Satisfaction; Physical Function; Placebo Control; Procedures; Professional Organizations; Prostate; Prostate specific antigen measurement; Quality of life; Radical Prostatectomy; Ramp; Randomized; Recommendation; Recording of previous events; Recurrent disease; Request for Applications; Research; Research Activity; Safety; Savings; Sex Behavior; Sex Functioning; Sexual Dysfunction; Site; Southwest Oncology Group; Structure; Surveys; Suspensions; Symptoms; Testing; Testosterone; United States National Institutes of Health; Urogenital Cancer; Urology; VO2max; clinical practice; coronavirus disease; disorder risk; efficacy evaluation; efficacy trial; health related quality of life; improved; instrument; men; muscle form; muscle strength; parent project; participant enrollment; payment; performance based measurement; pre-pandemic; programs; prostate cancer survivors; randomized trial; recruit; screening; survivorship; symptomatic improvement; testosterone replacement therapy

Summary This application requests close-out funds to enable completion of the trial and accomplishment of the proposed aims of the project. This planned extension of the trial, discussed previously on several occasions during the past 2 years with the trial's DSMB and the program staff, was necessitated because of the nationwide suspension of clinical research activities in 2020 due to the onset of the COVID-19 pandemic. Even after the complete suspension of non-Covid clinical research activities was lifted, the subsequent ramp up of clinical research activities in 2020 and 2021 was substantially slower than in the pre-pandemic period due to the COVID-related restrictions and other reasons that are described in the Research Strategies section. These COVID-related constraints substantially slowed participant enrollment and delayed the completion of the trial. With the gradual lifting of these Covid-related restrictions during the past year, and a number of steps implemented by the study team that are described in the Research Strategies section, including the addition of a second trial site at the Brady Urology Center at the Johns Hopkin Medical Institutions; increased personnel effort for participant screening; and some DSMB-recommended revisions of eligibility criteria, the enrollment in the trial has increased substantially averaging 6 randomizations each month during the past several months. As described in the Research Strategies section, 61 participants had been enrolled as of December 31, 2022, including 23 in the past 4 months. We anticipate enrolling 85 subjects by the end of the current funding period (April 30, 2023) and completing the enrollment during the extension period. The close- out funds are requested for completing the planned recruitment in the trial and accomplishing the approved aims of this project. There was saving of costs associated with laboratory tests, procedures, and subject payments; these savings will be carried forward and no additional funds have been requested for these activities.

总结 该申请要求提供收尾资金，以完成试验， 实现项目的预期目标。这次计划延长试验， 在过去2年中与试验的DSMB多次讨论 由于全国范围内的暂停， 2020年，由于COVID-19疫情爆发，临床研究活动减少。甚至 在全面暂停非新冠肺炎临床研究活动后， 2020年和2021年临床研究活动的后续增加， 由于COVID相关限制和其他因素， 研究策略部分中描述的原因。这些与COVID相关的 限制大大减缓了参与者的登记，并推迟了 庭审随着过去一年逐步取消这些与Covid相关的限制， 以及研究小组实施的一些步骤， 研究战略部分，包括在布雷迪增加第二个试验中心 约翰霍普金斯医疗机构的泌尿外科中心;增加人员努力， 参与者筛选;以及一些DSMB建议的资格标准修订， 试验的入组人数显著增加，平均每次6例随机化 在过去的几个月里。如研究策略部分所述， 截至2022年12月31日，共有61名参与者入组，其中过去4年有23名参与者。 个月我们预计在目前的资助期结束前招募85名受试者 （2023年4月30日），并在延长期内完成入组。最后- 申请资金用于完成试验中计划的征聘工作， 实现本项目的既定目标。节省了相关费用 与实验室检查，程序和受试者支付;这些节省将进行 这些活动没有要求额外的资金。