跳至主要内容
临床试验/NCT00503646
NCT00503646Unknown不适用

Communication and Intimacy-Enhancing Intervention for Men Diagnosed With Early Stage Prostate Cancer and Their Partners: A Pilot and Feasibility Trial

Memorial Sloan Kettering Cancer Center3 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2007年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
3
主要终点
Feasibility and acceptability

研究概览

简要总结

RATIONALE: Participating in a therapy program may enhance communication and intimacy between men with prostate cancer and their partners.

PURPOSE: This randomized clinical trial is studying how well therapy enhances communication and intimacy for men with early stage prostate cancer and for their partners.

详细描述

OBJECTIVES:

Primary

  • To evaluate the feasibility and acceptability of conducting a randomized clinical trial evaluating communication and intimacy-enhancing intervention (CI) vs usual care (UC).
  • To collect descriptive information and basic psychometrics on proposed study measures.
  • To gather preliminary data regarding the impact of CI on couples' psychosocial adaptation, relationship closeness, and sexual intimacy in order to calculate power for a larger full scale trial.

OUTLINE: This is a multicenter study. Patients and their partners are randomized to 1 of 2 intervention arms.

  • Arm I: Patients and their partners receive communication and intimacy-enhancing intervention (CI) once a week comprising the following five 90-minute sessions: Rationale and Overview; Basic Communication; Intimacy and Sexuality; Improving Intimacy; and Reflecting on Changes and Cancer Survivorship.
  • Arm II: Patients and their partners receive standard psychological and emotional care (usual care [UC]) (i.e., social work consultations and referral to a psychiatrist or psychologist, if requested or deemed necessary by the attending physician).

研究设计

研究类型
Interventional
分配方式
Randomized

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Feasibility and acceptability

Descriptive characteristics of study measures

Impact of communication intervention on couples' psychological adaptation, relationship closeness, and sexual intimacy

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (3)

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