跳至主要内容
临床试验/NCT03227744
NCT03227744终止不适用

A Pilot Study of Prostate Cancer-specific Anxiety in Active Surveillance

NYU Langone Health2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2017年4月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
26
试验地点
2
主要终点
Assessment of FACT-P Scores

研究概览

简要总结

This study is a clinical trial to determine whether a 12-week group therapy intervention for patients undergoing Active Surveillance for Prostate Cancer can relieve disease-related anxiety and improve quality of life and delay elective treatment of prostate cancer. The goal of the study is to further our understanding of anxiety in men who have been diagnosed with prostate cancer and are undergoing Active Surveillance. Men who have elected Active Surveillance for their management of prostate cancer are eligible to participate in this study. After signing informed consent, all participants will complete two brief questionnaires (The Memorial Anxiety Scale for Prostate Cancer [MAX-PC] and the General Anxiety and Depression Scale 7 [GAD-7] to measure their anxiety levels. If the participant scores above a certain number, they will be asked to participate in the study. Patients will be randomly assigned to either a control group, who will receive no treatment, but continue to follow up with their urologist to manage their prostate cancer as usual, or the treatment group. The treatment group will receive 12 one-hour group therapy sessions that will take place once a week for 12 weeks with a licensed psychologist free of charge. They will be instructed to follow up with their urologist as previously determined for their prostate cancer management. Patients in both groups will be monitored for anxiety completing three questionnaires, the MAX-PC and GAD-7 which they previously completed, and the Functional Assessment of Cancer Therapy - Prostate (FACT-P) during the 4th and 12th weeks of therapy. If patients require further therapy beyond the group treatment sessions, the investigators may refer them to a psychologist or psychiatrist for further treatment.

研究设计

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

入排标准

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

入选标准

  • Age of 40
  • Primary diagnosis of Prostate Cancer
  • Initial MAX-PC score of ≥
  • Sign a consent form allowing related information to be included in this research.

排除标准

  • Prostate cancer is not their primary diagnosis.
  • Have pre-existing diagnosed psychiatric conditions, are currently taking psychotropic medications (e.g., antidepressants, anxiolytics, mood stabilizers.)
  • Have been diagnosed with cancer other than prostate cancer (and non-melanoma skin cancer)
  • Evidence of active substance abuse.
  • Participants in the treatment group who are absent from more than 3 therapy sessions will be excluded.

研究组 & 干预措施

Enrolled in group therapy

Active Comparator

Patients in the group therapy arm will be enrolled in group therapy and be issued surveys.

干预措施: Group therapy (Behavioral)

Enrolled in group therapy

Active Comparator

Patients in the group therapy arm will be enrolled in group therapy and be issued surveys.

干预措施: Surveys (Other)

Not enrolled in group therapy

Placebo Comparator

Patients in control arm will be issued surveys

干预措施: Surveys (Other)

结局指标

主要结局

Assessment of FACT-P Scores

时间窗: Change from baseline to 4 weeks to 12 weeks

Two groups, the experimental (recipients of group therapy) and the control (literature only) will be compared for anxiety based on their FACT-P questionnaire scores. Twenty-seven questions about physical, social/family, emotional and functional well-being are graded from 0-4 (0 = not at all; 4 = very much), yielding a total between 0 and 108.

Assessment of MAX-PC Scores

时间窗: Change from baseline to 4 weeks to 12 weeks

Two groups, the experimental (recipients of group therapy) and the control (literature only) will be compared for anxiety based on their MAX-PC questionnaire scores. Eighteen questions about anxiety related to prostate cancer and prostate specific antigen (PSA) tests are graded from 0-3 (0 = not at all; 3 = often), yielding a total between 0 and 54.

次要结局

  • Assessment of anxiety scores as a function of time(Change from baseline to 4 weeks to 12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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