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临床试验/NCT05324098
NCT05324098已完成不适用

Leveraging Technology (STAND-T) to Achieve Equity for Men With Prostate Cancer on Androgen Deprivation Therapy

University of California, San Francisco4 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2022年3月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
47
试验地点
4
主要终点
Completion rate

研究概览

简要总结

This clinical trial studies a digital platform, the supportive therapy in androgen deprivation (STAND-T), in achieving equity for men undergoing treatment with androgen deprivation therapy for prostate cancer. STAND-T is a digital platform that provides prostate health information, evidence-based materials and resources. STAND-T may help improve health, address symptoms, and promote equity in men with prostate cancer.

详细描述

PRIMARY OBJECTIVE:

I. To assess study feasibility of the STAND-T program at the Helen Diller Family Comprehensive Cancer Center (HDFCCC) and Zuckerberg San Francisco General Hospital and Trauma Center (ZSFG) genitourinary (GU) medical, surgical, and radiation oncology practices.

SECONDARY OBJECTIVE:

I. To measure preliminary estimates of acceptability and usage of a digital platform, STAND-T.

EXPLORATORY OBJECTIVE:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Age >18 years
  • Ability to understand study procedures and to comply with them for the entire length of the study
  • Ability of individual or legal guardian/representative to understand an informed consent document and the willingness to sign it
  • Adenocarcinoma of the prostate
  • Current or planned anti-androgen therapy (ADT) (oral or injection) with gonadotropin-releasing hormone (GnRH) antagonist or luteinizing hormone releasing hormone (LHRH) agonist
  • Life expectancy duration of 6 months or longer from date of study consent
  • Prior and concurrent radiation is allowed
  • Treatment with concurrent androgen signaling inhibitors is allowed
  • < 75 minutes/week of vigorous aerobic exercise based on Godin survey or < 2 days per week of vigorous activity

排除标准

  • Contraindication to any study-related procedure or assessment
  • Planned surgery/chemotherapy/immunotherapy/parp inhibitor treatment during the study period
  • Prior and concurrent investigational therapies
  • Unable to read/speak English
  • Unable to access the Internet
  • Has seen an exercise counselor in the past 6 months for prostate or cardiovascular health
  • Has seen a dietary counselor in the past 6 months for prostate or cardiovascular health

结局指标

主要结局

Completion rate

时间窗: Up to 3 months

The point estimation and 95% confidence interval (CI) of the percentage of participants who complete the 3-month study will be obtained overall and by race/ethnicity and geography.

次要结局

  • Participants reported satisfaction level(Up to 3 months)
  • Change in the proportion of men who were Extremely Satisfied/Satisfied(Up to 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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