Pilot Study of an Intimacy Enhancement Intervention for Couples Facing Breast Cancer
2018年10月24日 更新者：Fox Chase Cancer Center
The central goal of this study is to examine the feasibility, acceptability, and preliminary efficacy of the IE intervention on patient and partner sexual QOL and relationship outcomes, and on patient psychosocial outcomes.
We expect that the IE will show adequate feasibility, acceptability, and preliminary efficacy.
Secondarily, based on the rationale that barriers exist that limit participation in intensive sexual QOL interventions for breast cancer survivors, an innovative secondary aim will investigate the perspectives of study-eligible patient candidates who opt out of participating in the pilot trial.
We expect that we will be able to identify the participation barriers and intervention preferences of breast cancer survivors with sexual concerns who opt out of the intensive trial in order to inform the development of different interventions for future study.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
89
阶段
- 不适用
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
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、美国、19111
- Fox Chase Cancer Center
-
-
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
有资格学习的性别
女性
描述
Inclusion Criteria:
- Female
- Age > 21 years
- Has diagnosis of non-recurrent stage I-III breast cancer
- Completed active treatment (e.g., chemotherapy, radiation therapy, surgery) 6 months-5 years ago (current use of endocrine therapy is acceptable)
- Has a partner or spouse who is > 21
- Lives with a romantic partner > 6 months
- Score of > 3 on Patient Care Monitor Sexual Concerns screening item
- No hearing impairment in patient or partner
Exclusion Criteria:
- Not able to speak English, as stated in medical record or as observed by study team member
- ECOG Performance score > 2 OR too ill to participate as judged by physician/in medical record
- Overt cognitive dysfunction or psychiatric disturbance such as suicidal ideation or severe mental illness, as observed or judged by the researcher, referring source, or other qualified observer.
- Past history of any cancer other than non-melanoma skin cancer
- Currently participating in couple/marital therapy
- Currently pregnant
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
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Intimacy Enhancing Intervention
Participants attend 4 intimacy enhancement intervention sessions over 75 minutes every other week for 4 weeks.
The intimacy enhancement intervention comprises 4 main sessions: understanding impact of breast cancer on sex and intimacy, communication about sex/intimacy, problem-solving and changing thoughts, and planning ahead and preparing for challenges.
Participants are encouraged to participate in written and behavioral activities at home.
|
Participants attend 4 intimacy enhancement intervention sessions over 75 minutes every other week for 4 weeks.
The intimacy enhancement intervention comprises 4 main sessions: understanding impact of breast cancer on sex and intimacy, communication about sex/intimacy, problem-solving and changing thoughts, and planning ahead and preparing for challenges.
Participants are encouraged to participate in written and behavioral activities at home.
Receive couple-based intimacy enhancement intervention
|
|
有源比较器：Living Healthy Together
Participants receive educational information and support about breast cancer every other week for 4 weeks.
The educational information and support comprises topics about breast cancer, its treatments, sleep, energy, stress, stress management, nutrition, and diet.
Participants are encouraged to read educational materials.
|
Participants receive educational information and support about breast cancer every other week for 4 weeks.
The educational information and support comprises topics about breast cancer, its treatments, sleep, energy, stress, stress management, nutrition, and diet.
Participants are encouraged to read educational materials.
Receive educational information and support
|
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 |
|---|---|---|
|
Feasibility of the Treatment as Measured Through Study Accrual
大体时间：Up to 8 weeks
|
Feasibility is measured through the percentage of study eligible individuals who enrolled in the intervention study (i.e., acceptance rate).
|
Up to 8 weeks
|
|
Feasibility of the Treatment as Measured Through Study Attrition
大体时间：Up to 8 weeks
|
Feasibility of treatment is measured through the number of randomized participants who completed the study.
|
Up to 8 weeks
|
|
Feasibility of the Treatment as Measured Through Session Completion by Participant
大体时间：Up to 8 weeks
|
Feasibility of the treatment as measured through number of randomized participants who completed all 4 telephone sessions.
|
Up to 8 weeks
|
|
Acceptability Measured Using the Client Satisfaction Questionnaire (CSQ-8)
大体时间：Up to 8 weeks
|
Acceptability was measured through the median score on a validated acceptability measure.
Item responses run on a scale of 1 to 4, with a total score range of 8-32.
Higher scores indicate higher satisfaction with the service (acceptability).
A median score of 28 or higher is considered acceptable.
This measure was collected for both patients and partners.
|
Up to 8 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Sexual Function Measured Using the Female Sexual Function Index (FSFI)
大体时间：Baseline to up to 8 weeks
|
Total scale scores range from 2 to 36.
Higher scores indicate higher level of functioning.
Change in mean patient FSFI score from pre-intervention to post-intervention is reported.
Positive mean change scores indicate increase in sexual functioning from pre- to post-intervention.
|
Baseline to up to 8 weeks
|
|
Change in Sexual Function Measured Using the International Index of Erectile Function
大体时间：Baseline to up to 8 weeks
|
Total scale scores range from 1 to 75, with higher scores indicating a higher level of sexual functioning.
Change in mean male partner IIEF score from pre-intervention to post-intervention is reported.
Positive mean change scores indicate increase in sexual functioning from pre- to post-intervention.
|
Baseline to up to 8 weeks
|
|
Change in Sexual Satisfaction Measured Using the Patient-Reported-Outcomes Measurement Information System (PROMIS) Sexual Satisfaction Items
大体时间：Baseline to up to 8 weeks
|
The PROMIS uses T-scores that are calculated against U.S. population norms with a M of 50 and SD of 10.
Higher T-scores indicate higher levels of sexual satisfaction.
Change in sexual satisfaction T-scores from pre-intervention to post-intervention are reported.
Positive change scores indicate increase in sexual satisfaction from pre- to post-intervention.
|
Baseline to up to 8 weeks
|
|
Change in Sexual Distress Measured Using the Female Sexual Distress Scale-Revised
大体时间：Baseline to up to 8 weeks
|
Total scale scores range from 0 to 52.
Higher scores indicate higher levels of sexual distress.
Change in patient mean sexual distress score from pre-intervention to post-intervention is reported.
Negative mean change scores indicate decrease in sexual distress from pre- to post-intervention.
|
Baseline to up to 8 weeks
|
|
Change in Beliefs (Self-efficacy)
大体时间：Baseline to up to 8 weeks
|
Total scale scores range from 0 to 100.
Higher scores indicate higher degree of self-efficacy for coping with sexual concerns.
Change in mean self-efficacy score from pre-intervention to post-intervention is reported.
Positive mean change scores indicate increase in self-efficacy from pre- to post-intervention.
|
Baseline to up to 8 weeks
|
|
Change in Emotional Intimacy Measured Using the Personal Assessment of Intimacy in Relationships (PAIR) Emotional Intimacy Scale
大体时间：Baseline to up to 8 weeks
|
Total scale scores range from 1 to 5. Higher scores indicate higher level of emotional intimacy with one's partner.
Change in mean emotional intimacy score from pre-intervention to post-intervention is reported.
Positive mean change scores indicate increase in emotional intimacy from pre- to post-intervention.
|
Baseline to up to 8 weeks
|
|
Change in Sexual Communication Measured Using the Dyadic Sexual Communication Scale
大体时间：Baseline to up to 8 weeks
|
Total scale scores range from 13 to 78.
Higher scores indicate more communication.
Change in mean sexual communication score from pre-intervention to post-intervention is reported.
Positive mean change scores indicate increase in sexual communication from pre- to post-intervention.
|
Baseline to up to 8 weeks
|
|
Change in Relationship Quality Measured Using the Dyadic Adjustment Scale-7 Item
大体时间：Baseline to up to 8 weeks
|
Total scale scores range from 0 to 36.
Higher scores indicate higher relationship quality.
Change in mean relationship quality score from pre-intervention to post-intervention is reported.
Positive mean change scores indicate increase in relationship quality from pre- to post-intervention.
|
Baseline to up to 8 weeks
|
|
Change in Body Image Distress Measured Using the Body Image Scale
大体时间：Baseline to up to 8 weeks
|
Total scale scores range from 0 to 30.
Higher scores indicate higher level of body image distress.
Change in mean body image distress score from pre-intervention to post-intervention is reported.
Negative mean change scores indicate decrease in body image distress from pre- to post-intervention.
|
Baseline to up to 8 weeks
|
|
Change in Depression Measured Using the Patient Health Questionnaire-9 Item
大体时间：Baseline to up to 8 weeks
|
Total scale scores range from 0 to 27.
Higher scores indicate higher level of depression.
Change in mean depression score from pre-intervention to post-intervention is reported.
Negative mean change scores indicate decrease in depression from pre- to post-intervention.
|
Baseline to up to 8 weeks
|
|
Change in Anxiety Measured Using the Generalized Anxiety Disorder 7-item
大体时间：Baseline to up to 8 weeks
|
Total scale scores range from 0 to 21.
Higher scores indicate higher levels of anxiety.
Change in mean anxiety score from pre-intervention to post-intervention is reported.
Negative mean change scores indicate decrease in anxiety from pre- to post-intervention.
|
Baseline to up to 8 weeks
|
|
Change in Cancer-related Distress Using the Impact of Events Scale-Revised
大体时间：Baseline to up to 8 weeks
|
Total scale scores range from 0 to 88.
Higher scores indicate higher levels of distress.
Change in mean cancer-related distress score from pre-intervention to post-intervention is reported.
Negative mean change scores indicate decrease in distress from pre- to post-intervention.
|
Baseline to up to 8 weeks
|
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。
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)
2015年10月27日
初级完成 (实际的)
2017年9月29日
研究完成 (实际的)
2017年9月29日
研究注册日期
首次提交
2016年3月14日
首先提交符合 QC 标准的
2016年3月28日
首次发布 (估计)
2016年3月29日
研究记录更新
最后更新发布 (实际的)
2018年10月25日
上次提交的符合 QC 标准的更新
2018年10月24日
最后验证
2018年10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.
Intimacy Enhancing Intervention的临床试验
-
University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动，不招人
-
University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University主动，不招人