ACT-ED: Acceptance and Commitment Therapy for Erectile Dysfunction Adaptation of ACT for Compliance With an Erectile Rehabilitation Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- To investigate the feasibility
研究概览
简要总结
The investigators know that treatment for prostate cancer and erectile dysfunction can impact sexual health and quality of life. They want to learn how the treatment affects one's emotional and social well-being.
They have developed a new type of counseling. Cancer patients seek counseling for lots of reasons. It often helps them cope because they can express their feelings with a trained professional. They hope that this counseling will teach patients skills that they can use to comply with erectile treatment programs, improve their sexual health and quality of life. These skills may also improve physical and emotional well-being. As part of this study they will ask the patient to provide feedback on the proposed counseling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men who are 1 to 3 years post radical prostatectomy for early stage prostate cancer
- •Participated in penile injection program
- •Are able to speak, read, write and understand English well enough to complete study assessment and communicate with an English speaking therapist
- •Men who are up to 9 months post radical prostatectomy.
- •Had good erectile functioning pre-surgery (i.e., 24 or greater on the IIEF Erectile Function Domain (EFD) score), graded their erections as a 1 or 2 on the standard 5 point Urology Erectile Function scale) or have a score of 7 or greater on the 1-10 pre-surgery erectile function scale on the SMRP assessment)
- •Seen at MSKCC"s Sexual Medicine Rehabilitation Program (SMRP)
- •Advised by the clinical staff of the SMRP to start penile injections.
排除标准
- •Recurrence or progression of disease,
- •Specific injection phobia (self report)
- •A history of bipolar disorder or psychotic disorder (determined from self-report and/or chart review)
- •Current major depression (determined by self report and/or clinician observation and assessment) that would preclude from giving informed consent or being an active participant in a focus group
- •Specific injection phobia (self report)
- •A history of bipolar disorder or psychotic disorder (determined from self-report and/or chart review)
- •Current major depression (determined by self report and/or clinician observation and assessment) that would preclude from giving informed consent or being an active participant in a therapeutic session.
研究组 & 干预措施
(SMRP) + nurse practitioner information phone calls
Part A will use focus groups to gain feedback and refine the intervention. Part B will consist of a randomized pilot study where 70 men will be randomly assigned to one of two conditions: Sexual Medicine Rehabilitation (SMRP) plus nurse practitioner information phone calls and monitoring (SMRP+I), or SMRP plus the novel psychological intervention of Acceptance and Commitment Therapy for ED (SMRP+ACT-ED).
干预措施: Sexual Medicine Rehabilitation Program + nurse practitioner information phone calls (Behavioral)
SMRP+ACT-ED
Part A will use focus groups to gain feedback and refine the intervention. Part B will consist of a randomized pilot study where 70 men will be randomly assigned to one of two conditions: Sexual Medicine Rehabilitation (SMRP) plus nurse practitioner information phone calls and monitoring (SMRP+I), or SMRP plus the novel psychological intervention of Acceptance and Commitment Therapy for ED (SMRP+ACT-ED).
干预措施: Sexual Medicine Rehabilitation Program + Acceptance and Commitment Therapy for Erectile Dysfunction (Behavioral)
结局指标
主要结局
To investigate the feasibility
时间窗: 2 years
acceptability, tolerability and adherence) of adapted ACT psychotherapy treatment integrated into an erectile rehabilitation program (i.e., ACT-ED).
次要结局
- To investigate the impact of ACT-ED(2 years)