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直肠癌患者的性健康

2026年8月4日 更新者:Memorial Sloan Kettering Cancer Center

直肠癌患者的性健康:初步研究

我们知道直肠癌、结直肠癌或肛门癌的治疗会影响性功能。 本研究旨在学习:

  • 治疗如何影响情绪和社会福祉。
  • 新的性健康教育计划如何影响您。

癌症患者寻求教育的原因有很多。 它通常可以帮助他们应对,因为他们可以向训练有素的专业人员表达自己的感受。 这项研究对接受过直肠癌、结直肠癌或肛门癌治疗的个人开放。 它涉及一种新型的性健康咨询项目。 它将向参与者传授他们可以用来改善性生活的技能。 这些技能还可以改善身心健康。 我们会将新型性健康计划与直肠癌、结直肠癌或肛门癌治疗后患者接受的标准护理进行比较。

研究概览

详细说明

这是一项为期两年的随机临床试验,旨在检验旨在改善直肠癌幸存者性功能的干预措施的可行性、耐受性、可接受性(包括依从性)和有效性。

我们已经完成了女性患者的入组,目前正在收集随访数据。 正在招募男性患者。 男性参与者现在将以 3:1 的比例随机分配到干预条件 (n = 40) 或控制条件 (n = 40)。

研究类型

观察性的

注册 (实际的)

149

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • New York
      • New York、New York、美国、10065
        • Memorial Sloan Kettering Cancer Center
      • New York、New York、美国、10029
        • Mount Sinai Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

21年 及以上 (成人、年长者)

接受健康志愿者

不

取样方法

概率样本

研究人群

结直肠癌患者

描述

纳入标准:

  • I-III 期直肠腺癌或直肠乙状结肠癌的放疗和/或手术后至少六个月,吻合口在 15 cm 或以下并完成治疗
  • 肛门癌放疗和/或化疗后至少六个月。
  • 没有疾病或复发的证据
  • 对于女性,表示对她们的整体性生活表示中等满意度或更低(在“过去 4 周内,您对整体性生活的满意度如何?”这个问题上得分为“4”或更低)
  • 对于男性,在“您如何评价自己能够勃起并保持勃起的信心”这个问题上得分为“3”或更低),在“多少”这个问题上得分为“2”或更高这个问题困扰你吗?
  • 根据同意的专业干预人员的判断,能够用英语很好地交流以使用英语进行工作并完成学习评估。
  • 年满 21 岁或以上。

排除标准:

  • 根据研究者的判断,严重的认知或精神障碍足以排除参与心理治疗干预。
  • 积极参与协议 06-151
  • 参加焦点小组或定性访谈。

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
1个
常规护理 (UC),这是患者接受的标准护理
随机分配到常规护理组的参与者将接受标准护理。 对于女性,这被定义为未参与干预的参与者得到的照顾;我们将询问这些参与者他们正在接受哪些社会心理护理,以追踪日常护理。 对于男性,“常规护理”将包括标准化转介到 MSKCC 的男性性医学计划,以及美国癌症协会 (ACS) 癌症后性行为手册形式的书面信息。 随机接受常规护理的个人将不会接受研究干预人员的任何额外咨询课程,直到他们完成跟进访谈,然后才会提供给他们。 后续调查问卷将在基线后 4 个月和 8 个月评估所有研究参与者。
2个
癌症幸存者干预-性健康 (CSI-SH) 加常规护理(美国)
这涉及四个 1 小时的单独会话,并在四个会话之间提供三个额外的电话助推器/复习会话。 会议可以亲自完成或通过电话进行。 尽管将尽一切努力在咨询会议之间完成加强会议,但如果患者无法完成加强电话,他们可能会被跳过。 第一节和第二节将重点介绍康复技术和工具,在前两节期间将提供并与参与者讨论。

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Female Sexual Functioning Index (FSFI) Total Score for Women From Baseline to Follow-up 1
大体时间:4 months post-baseline (follow-up 1)
The FSFI (Female Sexual Functioning Index) is a brief, self-report measure of female sexual function. The 19 items use a 5-point Likert scale ranging from 1-5 with higher scores indicating greater levels of sexual function. The total score for the Female Sexual Function Index (FSFI) ranges from a minimum of 2.0 to a maximum of 36.0
4 months post-baseline (follow-up 1)
Change in Female Sexual Functioning Index (FSFI) Total Score for Women From Baseline to Follow-up 2
大体时间:8 months post-baseline (follow up 2)
The FSFI is a brief, self-report measure of female sexual function. The 19 items use a 5-point Likert scale ranging from 1-5 with higher scores indicating greater levels of sexual function. The total score for the Female Sexual Function Index (FSFI) ranges from a minimum of 2.0 to a maximum of 36.0
8 months post-baseline (follow up 2)
Changes International Index of Erectile Function (IIEF) for Men From Baseline to Follow up 1
大体时间:4 months post-baseline (follow up 1)
The IIEF is a 15-item questionnaire designed to assess erectile functioning. Scores of 0 to 5 are awarded to each of the 15 questions. The five domains assessed include Erectile Function (Max score 30), Orgasmic Function (Max score 10), Sexual Desire (Max score 10), Intercourse Satisfaction (Max score 15) and Overall Satisfaction (Max score 10). Overall Scoring: 1-10: Severe Erectile Dysfunction, 11-16: Moderate dysfunction,17-21: Mild to moderate dysfunction, 22-25: Mild dysfunction, 26-30: No dysfunction. Higher scores indicate better sexual function/better outcome.
4 months post-baseline (follow up 1)
Changes in International Index of Erectile Function (IIEF) for Men From Baseline to Follow up 2
大体时间:8 months post-baseline (follow-up 2)
The IIEF is a 15-item questionnaire designed to assess erectile functioning. Scores of 0 to 5 are awarded to each of the 15 questions. The five domains assessed include Erectile Function (Max score 30), Orgasmic Function (Max score 10), Sexual Desire (Max score 10), Intercourse Satisfaction (Max score 15) and Overall Satisfaction (Max score 10). Overall Scoring: 1-10: Severe Erectile Dysfunction, 11-16: Moderate dysfunction,17-21: Mild to moderate dysfunction, 22-25: Mild dysfunction, 26-30: No dysfunction. Higher scores indicate better sexual function/better outcome.
8 months post-baseline (follow-up 2)

次要结果测量

结果测量
措施说明
大体时间
Change in Impact of Events Scale-Revised (IES-R) Total Score for Women and Men From Baseline to Follow up 1
大体时间:4 months post-baseline (follow up 1)
The IES-R is a self-report measure designed to assess current subjective distress for any specific life event. Respondents rate each item in the IES-R on a scale of 0 (not at all), 1 (a little bit), 2 (moderately), 3 (quite a bit) and 4 (extremely) according to the past 7 days with regard to cancer and its treatment. the total score for the IES-R assessment can range from 0-88. In general, the higher the score, the more severely a person's life is disrupted by a traumatic event.
4 months post-baseline (follow up 1)
Change in Impact of Events Scale-Revised (IES-R) Total Score for Women and Men From Baseline to Follow up 2
大体时间:8 months post-baseline (follow up 2)
The IES-R is a self-report measure designed to assess current subjective distress for any specific life event. Respondents rate each item in the IES-R on a scale of 0 (not at all), 1 (a little bit), 2 (moderately), 3 (quite a bit) and 4 (extremely) according to the past 7 days with regard to cancer and its treatment. the total score for the IES-R assessment can range from 0-88. In general, the higher the score, the more severely a person's life is disrupted by a traumatic event.
8 months post-baseline (follow up 2)
Changes in Depression and Anxiety Symptom Dimension Scores of Brief Symptom Inventory (BSI) for Women From Baseline to Follow up 1
大体时间:4 months post-baseline (follow up 1)
The BSI (Brief Symptom Inventory) consists of 53 items. Participants rate the extent to which they have been bothered (0 ="not at all" to 4="extremely") in the past week by various symptoms. Higher scores indicate greater emotional distress. The BSI uses a 5-point Likert scale (0 = Not at all, 4 = Extremely), with rankings characterizing the intensity of distress during the past seven days. Scores are calculated as follows: Sum the item scores and divide by the number of items to obtain the mean score. Higher scores indicate greater emotional distress.
4 months post-baseline (follow up 1)
Changes in Depression and Anxiety Symptom Dimension Scores of Brief Symptom Inventory (BSI) for Women From Baseline to Follow up 2
大体时间:8 months post-baseline (follow up 2)
The BSI (Brief Symptom Inventory) consists of 53 items. Participants rate the extent to which they have been bothered (0 ="not at all" to 4="extremely") in the past week by various symptoms. Higher scores indicate greater emotional distress. The BSI uses a 5-point Likert scale (0 = Not at all, 4 = Extremely), with rankings characterizing the intensity of distress during the past seven days. Scores are calculated as follows: Sum the item scores and divide by the number of items to obtain the mean score. Higher scores indicate greater emotional distress.
8 months post-baseline (follow up 2)
Change in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Total Score for Women From Baseline to Follow up 1
大体时间:4 months post-baseline (follow up 1)
EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire ) is a well-validated instrument that assesses health-related quality of life in cancer patients. It is composed of 30-items, which factor into scales that evaluate physical functioning and role functioning, as well as emotional, social, and cognitive functioning and global QOL. Three symptom scales measure fatigue, pain, and emesis, while six single items assess financial impact, dyspnea, sleep disturbance, appetite, diarrhea, and constipation. The EORTC QLQ-C30 Summary Score is calculated from the mean of 13 of the 15 QLQ-C30 scales (the Global Quality of Life scale and the Financial Impact scale are not included). All of the scales and measures range in score from 0 to 100. A high scale score represents a higher response level/better outcome.
4 months post-baseline (follow up 1)
Change in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Total Score for Women From Baseline to Follow up 2
大体时间:8 months post-baseline (follow up 2)
EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire ) is a well-validated instrument that assesses health-related quality of life in cancer patients. It is composed of 30-items, which factor into scales that evaluate physical functioning and role functioning, as well as emotional, social, and cognitive functioning and global QOL. Three symptom scales measure fatigue, pain, and emesis, while six single items assess financial impact, dyspnea, sleep disturbance, appetite, diarrhea, and constipation. The EORTC QLQ-C30 Summary Score is calculated from the mean of 13 of the 15 QLQ-C30 scales (the Global Quality of Life scale and the Financial Impact scale are not included). All of the scales and measures range in score from 0 to 100. A high scale score represents a higher response level/better outcome.
8 months post-baseline (follow up 2)
Change in Male-specific Variables (SEAR and Sexual Bother Subscale of the PHR-QOL) for Men From Baseline to Follow up 1
大体时间:4 months post-baseline (follow up 1)
The Sexual Self-Esteem and Relationship Questionnaire (SEAR) is a 14-item measure that assesses sexual relationship satisfaction, sexual self-esteem, and overall relationship satisfaction. This measure was developed for use in men with ED. The items are scored on a 5-point Likert scale with higher scores indicating higher sexual satisfaction and sexual self-esteem. Higher scores indicated a more favorable response (0 = least favorable, 100 = most favorable). The Sexual Bother (SB) subscale of the Prostate-Health Related QOL (PHR-QOL) questionnaire is a 4-question scale that assesses men on a 5-point Likert scale (0-20). The four questions assess how sexual function has impacted close relationships, how big a problem it has been, if the patients have felt ashamed or embarrassed by their sexual function, and if it has impacted their ability to enjoy life. Higher scores indicate better outcomes (better functioning; less bother).
4 months post-baseline (follow up 1)
Change in Male-specific Variables (SEAR and Sexual Bother Subscale of the PHR-QOL) for Men From Baseline to Follow up 2
大体时间:8 months post-baseline (follow up 2)
The Sexual Self-Esteem and Relationship Questionnaire (SEAR) is a 14-item measure that assesses sexual relationship satisfaction, sexual self-esteem, and overall relationship satisfaction. This measure was developed for use in men with ED. The items are scored on a 5-point Likert scale with higher scores indicating higher sexual satisfaction and sexual self-esteem. Higher scores indicated a more favorable response (0 = least favorable, 100 = most favorable). The Sexual Bother (SB) subscale of the Prostate-Health Related QOL (PHR-QOL) questionnaire is a 4-question scale that assesses men on a 5-point Likert scale (0-20). The four questions assess how sexual function has impacted close relationships, how big a problem it has been, if the patients have felt ashamed or embarrassed by their sexual function, and if it has impacted their ability to enjoy life. Higher scores indicate better outcomes (better functioning; less bother).
8 months post-baseline (follow up 2)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Christian Nelson, PhD、Memorial Sloan Kettering Cancer Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2008年6月24日

初级完成 (实际的)

2024年11月21日

研究完成 (实际的)

2024年11月21日

研究注册日期

首次提交

2008年7月7日

首先提交符合 QC 标准的

2008年7月7日

首次发布 (估计的)

2008年7月10日

研究记录更新

最后更新发布 (实际的)

2026年8月26日

上次提交的符合 QC 标准的更新

2026年8月4日

最后验证

2024年11月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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