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临床试验/NCT02186444
NCT02186444已完成不适用

Navigator Guided e-Psychoeducational Intervention for Prostate Cancer Patients and Their Caregivers

H. Lee Moffitt Cancer Center and Research Institute1 个研究点 分布在 1 个国家目标入组 391 人开始时间: 2014年6月2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
391
试验地点
1
主要终点
Final Survey Results per Study Arm

研究概览

简要总结

The purpose of this study is to evaluate the impact of providing newly diagnosed prostate cancer patients and their caregivers with an interactive mobile tablet technology-based application delivered by a community navigator versus providing National Cancer Institute (NCI) information booklets delivered by a Community Navigator (CN) on patient outcomes (decisional satisfaction, quality of life, knowledge, decisional conflict) and shared decision making practices (decision making involvement).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Men newly diagnosed (within 6 months) with biopsy confirmed case of prostate cancer
  • 40 - 80 years of age
  • Able to speak and read English
  • Live within 120 miles of a healthcare treatment facility
  • Have no documented or observable visual, auditory, psychiatric, or neurological disorders that would interfere with study participation
  • Be able to complete telephone interviews
  • Have not completed the first course of treatment
  • Have a family member/caregiver willing to participate
  • Capable of providing written consent for study participation. Men diagnosed with early stage, locally advanced or metastatic disease or men who are on active surveillance will be eligible to participate in this study.
  • Caregiver must be aged 18 or older
  • Caregiver must be identified by patient as their caregiver (i.e., provider of emotional and/or physical care)
  • Caregiver must have not been diagnosed with cancer in the previous year or be receiving cancer treatment

排除标准

  • 未提供

结局指标

主要结局

Final Survey Results per Study Arm

时间窗: 6 months post baseline survey

Investigators plan to assess if the psycho-educational intervention, PHIN, delivered by a CN is more efficacious as compared to NCI Information Booklets (IB) delivered by a CN. Participants will be asked to complete a baseline set of surveys and follow-up surveys at three additional time points: (1) 6 weeks after receiving the educational intervention; (2) after the follow-up decision with their doctor or health care provider; and (3) 6 months after the baseline surveys were done.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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Navigator Guided e-Psychoeducational Intervention | 临床试验