Addressing Sexual Concerns in Breast Cancer: Patient Intervention Study
2021年3月15日 更新者：Fox Chase Cancer Center
Enhancing Patient-Provider Communication About Sexual Concerns in Breast Cancer: Patient Intervention Study
The goal of this study is to evaluate an educational video intervention (called Starting the Conversation) aimed to enhance breast cancer patients' beliefs about and communication with respect to sexual concerns.
In the current study, 128 breast cancer outpatients will be randomized to either participate in the video intervention and to receive a resource guide addressing sexual and menopausal health or to receive the resource guide alone.
Patients will be asked to participate in the video and/or read through the resource guide prior to their clinic visit with their breast cancer provider.
The investigators will examine effects of the interventions on patients' beliefs about communication about sexual health and on patients' communication about sexual health during clinic visits with their providers.
Secondarily, the investigators will examine effects of the interventions on sexual outcomes and other health outcomes, including psychological well-being and health-related QOL.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
153
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
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19111
- Fox Chase Cancer Center
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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:
- Receiving any treatment for breast cancer or have completed acute treatment for breast cancer < 10 years ago
- Attending clinic visits in the course of follow-up care (i.e., not an initial consult visit)
- Willing to have clinic visit audio recorded
Exclusion Criteria:
- Unable to speak English
- Eastern Cooperative Oncology Group (ECOG) Performance score > 2 OR too ill to participate as judged by physician, self-report, or observation of the research team member
- Overt cognitive dysfunction or psychiatric disturbance or severe mental illness (e.g., dementia, suicidal behavior, or psychosis), as observed or judged by the researcher or referring source.
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 |
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有源比较器：Resources Only
Patients will receive a list of resources on sexual and menopausal health in breast cancer.
They will be asked to review the resources before their next clinic visit.
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Patients will receive a resource list that includes both web-based resources on menopausal and sexual health and center-specific resources, such as contact information for a menopausal & sexual health clinic.
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实验性的：Resources + Video
Patients will receive a list of web resources on sexual and menopausal health in breast cancer.
In addition to the resources, patients will be asked to view an online video called "Starting the Conversation" and to complete an accompanying workbook.
Patients in this arm will be asked to review the resource list, watch the Starting the Conversation video, and complete the workbook before their next clinic visit.
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Patients will receive a resource list that includes both web-based resources on menopausal and sexual health and center-specific resources, such as contact information for a menopausal & sexual health clinic.
The Starting the Conversation program is designed to increase self-efficacy and outcome expectancies for communicating with providers about sexual health and related issues, reduce barriers to communication, and provide basic training in skills for communicating with providers about these topics, including prioritizing concerns, tips for effective communication, communication practice, and self-feedback.
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无干预：Clinician Arm
Clinicians were consented in order to have their clinic visits audio recorded.
No outcomes data were collected from clinician participants.
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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 |
|---|---|---|
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Self-Reported Self-Efficacy for Communicating About Sexual Health Issues
大体时间：2 weeks
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Two items assessed patients' self-efficacy (confidence) for communicating with their breast cancer clinician about sexual health concerns in terms of either talking (item 1) or asking (item 2) about sexual health.
Response options used an 11-point scale (0=not at all confident/not at all to 10=extremely confident/very much).
Mean scores across the two items were used, ranging from 0-10.
Higher scores indicate higher self-efficacy.
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2 weeks
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Self-Reported Self-Efficacy for Communicating About Sexual Health Issues
大体时间：2 months
|
Two items assessed patients' self-efficacy (confidence) for communicating with their breast cancer clinician about sexual health concerns in terms of either talking (item 1) or asking (item 2) about sexual health.
Response options used an 11-point scale (0=not at all confident/not at all to 10=extremely confident/very much).
Mean scores across the two items were used, ranging from 0-10.
Higher scores indicate higher self-efficacy.
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2 months
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Self-Reported Outcome Expectancies for Sexual Health Communication
大体时间：2 weeks
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Five items assessed the belief that discussing sexual health with her breast cancer clinician would lead to positive outcomes (e.g., "find a solution to a problem").
Response options used an 11-point scale (0=not at all to 10=very much).
Mean scores across the five items were used, ranging from 0-10.
Higher scores indicate higher expectancies for positive outcomes.
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2 weeks
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Self-Reported Outcome Expectancies for Sexual Health Communication
大体时间：2 months
|
Five items assessed the belief that discussing sexual health with her breast cancer clinician would lead to positive outcomes (e.g., "find a solution to a problem").
Response options used an 11-point scale (0=not at all to 10=very much).
Mean scores across the five items were used, ranging from 0-10.
Higher scores indicate higher expectancies for positive outcomes.
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2 months
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Number of Patients Who Asked at Least One Question About Sexual Health at Their Clinic Visit
大体时间：2 weeks
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As coded from clinic visit audio, the number of patients who ask at least one question about sexual health.
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2 weeks
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Number of Patients Who Initiate Conversation About Sexual Health in Their Clinic Visit
大体时间：2 weeks
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As coded from clinic visit audio, the number of patients who raise the topic of sexual health during their encounter (out of encounters where a sexual health discussion occurred).
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2 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Recruitment Rates (Feasibility)
大体时间：baseline
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Recruitment rates, as measured by percentage of patients enrolled (i.e., baselined) out of eligible patients approached for the study.
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baseline
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Retention Rates (Feasibility)
大体时间：2 weeks
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Retention rates, as measured by percentage of patients who remain on study for 2-week follow-up assessment.
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2 weeks
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Retention Rates (Feasibility)
大体时间：2 months
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Retention rates, as measured by percentage of patients who remain on study for 2-month follow-up assessment.
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2 months
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Intervention Acceptability
大体时间：2 weeks
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Acceptability of intervention, as measured through the item "Overall, how satisfied were you with this program?".
Responses options include Very Satisfied, Satisfied, Dissatisfied, and Very Dissatisfied.
Responses of "satisfied" or "very satisfied" indicate acceptability.
Number of patients reporting acceptability and number of patients not reporting acceptability are presented.
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2 weeks
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Sexual Activity
大体时间：2 months
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Sexual activity was measured by a single item asking (yes/no) whether the participant had any kind of sexual activity in the past 30 days.
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2 months
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Sexual Function
大体时间：2 months
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Sexual function was assessed using the Lubrication, Vaginal Discomfort, Satisfaction, and Interest domain scores from the Patient-Reported Outcomes Measurement Information System Sexual Function and Satisfaction scale (PROMIS SexFS) Brief Profile Version 2.0.
Scores are converted to a T-score metric where a score of 50 equates to the mean of the U.S. population of sexually active adults (SD=10).
Higher scores for all domains except Vaginal Discomfort signify better function.
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2 months
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General Self-Efficacy for Communication With Provider
大体时间：2 months
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Patients' self-efficacy for communicating with provider generally, as measured through the Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5).
The PEPPI-5 is a five-item scale that measures patient confidence in communicating with providers.
Response options are on a scale from 1 (Not at All Confident) to 5 (Very Confident) and are summed for a total self-efficacy score (Range: 5-25).
Higher scores indicate higher self-efficacy.
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2 months
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Barriers to Communicating About Sexual Health
大体时间：2 months
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Patient barriers to communication about sexual health, as measured through a 13-item scale.
Scale items cover potential reasons a patient might not want to discuss sexual health concerns with her provider (e.g., "I might become embarrassed").
Items are scored on a 1-5 scale where 1=Strongly Disagree and 5=Strongly Disagree.
A total barrier score will be taken from this scale (Range: 13-65).
Higher scores indicate more perceived barriers to communication.
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2 months
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Self-Reported Anxiety
大体时间：2 months
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Patients self-reported anxiety, as measured through anxiety subscale of the Hospital Anxiety & Depression Scale (HADS).
The anxiety subscale consists of 7 items that are scored from 0 to 3. Summed scores range from 0 to 21, with higher scores indicating higher levels of anxiety.
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2 months
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Self-Reported Depression
大体时间：2 months
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Patients self-reported depression, as measured through depression subscale of the Hospital Anxiety & Depression Scale (HADS).
The depression subscale consists of 7 items that are scored from 0 to 3. Summed scores range from 0 to 21, with higher scores indicating higher levels of depression.
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2 months
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Self-Reported Quality of Life
大体时间：2 months
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Quality of life, as measured through the Abbreviated Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) total score.
The FACT-B contains 23 items about physical, functional, and emotional well-being in the context of breast cancer.
Scale items are scored from 0 to 4. Summed scores run from 0 to 92, with higher scores indicating higher quality of life.
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2 months
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Self-Reported Self-Efficacy for Communicating About About Treatment Side Effects
大体时间：2 weeks
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Patients' self-reported self-efficacy for communication about treatment side effects with their breast cancer provider.
The items about treatment side effects consist of 2 items within a larger 6-item scale which ask the patient how confident she is in talking to her provider about treatment side effects and asking her provider about treatment side effects.
Response options range from 0 (not at all confident) to 10 (extremely confident).
Mean scores will be reported.
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2 weeks
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Self-Reported Self-Efficacy for Communicating About About Treatment Side Effects
大体时间：2 months
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Patients' self-reported self-efficacy for communication about treatment side effects with their breast cancer provider.
The items about treatment side effects consist of 2 items within a larger 6-item scale which ask the patient how confident she is in talking to her provider about treatment side effects and asking her provider about treatment side effects.
Response options range from 0 (not at all confident) to 10 (extremely confident).
Mean scores will be reported.
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2 months
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Self-Reported Self-Efficacy for Communicating About About Menopausal Health
大体时间：2 weeks
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Patients' self-reported self-efficacy for communication about menopausal health with their breast cancer provider.
The items about menopausal health consist of 2 items within a larger 6-item scale which ask the patient how confident she is in talking to her provider about menopausal health and asking her provider about menopausal health.
Response options range from 0 (not at all confident) to 10 (extremely confident).
Mean scores will be reported.
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2 weeks
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Self-Reported Self-Efficacy for Communicating About About Menopausal Health
大体时间：2 months
|
Patients' self-reported self-efficacy for communication about menopausal health with their breast cancer provider.
The items about menopausal health consist of 2 items within a larger 6-item scale which ask the patient how confident she is in talking to her provider about menopausal health and asking her provider about menopausal health.
Response options range from 0 (not at all confident) to 10 (extremely confident).
Mean scores will be reported.
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2 months
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Self-Reported Outcome Expectancies for Communication About Treatment Side Effects
大体时间：2 weeks
|
Five items assessed the belief that discussing treatment side effects with her breast cancer clinician would lead to positive outcomes (e.g., "find a solution to a problem").
Response options used an 11-point scale (0=not at all to 10=very much).
Mean scores across the five items were used, ranging from 0-10.
Higher scores indicate higher expectancies for positive outcomes.
|
2 weeks
|
|
Self-Reported Outcome Expectancies for Communication About Treatment Side Effects
大体时间：2 months
|
Five items assessed the belief that discussing treatment side effects with her breast cancer clinician would lead to positive outcomes (e.g., "find a solution to a problem").
Response options used an 11-point scale (0=not at all to 10=very much).
Mean scores across the five items were used, ranging from 0-10.
Higher scores indicate higher expectancies for positive outcomes.
|
2 months
|
|
Self-Reported Outcome Expectancies for Communication About Menopausal Health
大体时间：2 weeks
|
Five items assessed the belief that discussing menopausal health with her breast cancer clinician would lead to positive outcomes (e.g., "find a solution to a problem").
Response options used an 11-point scale (0=not at all to 10=very much).
Mean scores across the five items were used, ranging from 0-10.
Higher scores indicate higher expectancies for positive outcomes.
|
2 weeks
|
|
Self-Reported Outcome Expectancies for Communication About Menopausal Health
大体时间：2 months
|
Five items assessed the belief that discussing menopausal health with her breast cancer clinician would lead to positive outcomes (e.g., "find a solution to a problem").
Response options used an 11-point scale (0=not at all to 10=very much).
Mean scores across the five items were used, ranging from 0-10.
Higher scores indicate higher expectancies for positive outcomes.
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2 months
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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)
2018年5月27日
初级完成 (实际的)
2019年12月31日
研究完成 (实际的)
2019年12月31日
研究注册日期
首次提交
2018年7月20日
首先提交符合 QC 标准的
2018年8月7日
首次发布 (实际的)
2018年8月10日
研究记录更新
最后更新发布 (实际的)
2021年3月16日
上次提交的符合 QC 标准的更新
2021年3月15日
最后验证
2021年3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.