跳至主要内容
临床试验/NCT01594593
NCT01594593已完成不适用

Pilot Study of an Acceptance and Commitment Therapy Workshop for Distress and Decision Making in Early Stage Prostate Cancer in Veterans

Veterans Medical Research Foundation2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2011年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
2
主要终点
Number of dropouts

研究概览

简要总结

Prostate cancer (PCa) is the most common type of cancer in men and the second leading cause of death in American men. Those diagnosed with localized prostate cancer encounter three sources of psychological distress: 1) diagnosis itself, 2) treatment decision making, and 3) the often life-altering side effects of treatment. In addition, patients who choose to undergo active surveillance which focuses on monitoring cancer in lieu of treatment, experience distress related to living with cancer. Acceptance and Commitment Therapy (ACT) is an established psychosocial intervention that has been used extensively for mental health treatment and has shown benefits for various chronic conditions. ACT is a behavioral intervention that focuses on tolerating distress and improving function. This pilot study is designed to test the feasibility of ACT for distress reduction and improved quality of life in patients recently diagnosed with early-stage, localized PCa.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • Localized prostate cancer in Stages I or II
  • Ability to give informed consent
  • Age 18 to 80 years old
  • Willingness to come in for a day long intervention

排除标准

  • Acute psychosis
  • Suicidal ideation
  • Homicidal ideation
  • Active substance abuse

结局指标

主要结局

Number of dropouts

时间窗: 6 months

Because this is a pilot study to determine feasibility, one of the primary outcomes is the number of participants who drop out of the active treatment arm.

Number of refusals

时间窗: 6 months

Because this is a pilot study to determine feasibility, one of the primary outcomes is the number of participants who refuse the active treatment arm.

次要结局

  • Hospital Anxiety and Depression Scale(baseline, post intervention, 2 weeks post intervention, 3 months post intervention)
  • Memorial Anxiety Scale for Prostate Cancer(baseline, post intervention, 2 weeks post intervention, 3 months post intervention)

研究者

发起方
Veterans Medical Research Foundation
申办方类型
Other
责任方
Sponsor

研究点 (2)

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