Efficacy of Written Versus Video Patient Education Materials for Postmastectomy Breast Reconstruction
2026年6月10日 更新者：University of California, San Francisco
Evaluating the Efficacy of Written Versus Video Patient Education Materials for Postmastectomy Breast Reconstruction Patients: Knowledge, Confidence, and Anxiety
This is a prospective, randomized controlled trial evaluating the comparative efficacy of written, video, and combined written and video patient education materials relative to no supplemental education for University of California, San Francisco (UCSF) patients presenting for post-mastectomy breast reconstruction consultation.
研究概览
地位
招聘中
条件
详细说明
PRIMARY OBJECTIVES:
- Assess baseline knowledge, procedural confidence, and anxiety in patients presenting for breast reconstruction consultation.
- Compare post-intervention outcomes between patients receiving written, video, or combined educational materials relative to no supplemental education.
SECONDARY OBJECTIVES
1. Examine whether the relative efficacy of each modality differs across patient subgroups defined by age, area deprivation index score, and prior health literacy.
OUTLINE:
Participants will be randomized into 1 of 4 groups:
- Written educational intervention
- Video educational intervention
- Combined written and video educational intervention
- No additional educational intervention
Outcome measures are assessed at a single timepoint following participant review of assigned materials and prior to the clinical consultation. Enrolled participants who do not review their assigned educational materials prior to the clinical consultation will be excluded from primary analysis but will be included in secondary intent-to-treat analysis
研究类型
介入性
注册 (估计的)
100
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。
学习联系方式
- 姓名：Reta Behman, BA
- 电话号码：877-827-3222
- 邮箱：Reta.Behman@ucsf.edu
学习地点
-
-
California
-
San Francisco、California、美国、94143
- 招聘中
- University of California, San Francisco
-
接触：
- Reta Behnam-Hanona, BA
- 电话号码：877-827-3222
- 邮箱：Reta.Behnam@ucsf.edu
-
-
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
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Adults aged 18 or older
- Presenting as a new patient to the UCSF plastic surgery breast reconstruction clinic
- Considering mastectomy, including:
- - Therapeutic mastectomy in the setting of a breast cancer diagnosis
- - Prophylactic mastectomy in the setting of a confirmed high-risk genetic variant
- - Staged procedures, including delayed mastectomy with initial reduction
- Participants who are undecided between lumpectomy and mastectomy
Exclusion Criteria:
- Established patients returning for follow-up, in order to minimize confounding variables of individual surgeon education style on outcome measures
- Participants who are primarily considering lumpectomy or oncoplastic reduction at the time of their visit
- Non-English speakers, as educational materials are currently available in English only
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：Written Educational Intervention
On the day of consultation prior to meeting with the plastic surgeon, participants will receive a 20-page illustrated brochure covering the full range of reconstructive options and be asked to complete surveys.
Following the appointment, a medical chart review will be conducted.
|
Participants will complete health related questionnaires.
其他名称：
20-page illustrated brochure
其他名称：
Participants may have data collected from the medical record.
其他名称：
|
|
实验性的：Video Educational Intervention
On the day of consultation prior to meeting with the plastic surgeon, participants will receive a five-module video series totaling approximately 20 minutes featuring the senior author and will be asked to complete surveys; expected to take no longer than 10 minutes to complete.
Following the appointment, a medical chart review will be conducted.
|
Participants will complete health related questionnaires.
其他名称：
Participants may have data collected from the medical record.
其他名称：
Five-module video series
其他名称：
|
|
实验性的：Combined Educational Intervention
On the day of consultation prior to meeting with the plastic surgeon, participants in the combined arm will receive both written and video materials and will be asked to complete surveys.
Following the appointment, a medical chart review will be conducted.
|
Participants will complete health related questionnaires.
其他名称：
20-page illustrated brochure
其他名称：
Participants may have data collected from the medical record.
其他名称：
Five-module video series
其他名称：
|
|
其他：No Supplemental Education / Control Arm
On the day of consultation prior to meeting with the plastic surgeon, participants will be asked to complete surveys.
Following the appointment, a medical chart review will be conducted.
|
Participants will complete health related questionnaires.
其他名称：
Participants may have data collected from the medical record.
其他名称：
|
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 |
|---|---|---|
|
Mean scores on the Spielberger State-Trait Anxiety Inventory (STAI), State Form
大体时间：1 day, during appointment immediately prior to meeting with surgeon
|
STAI is a 20 items instrument for assessing trait anxiety and 20 for state anxiety for a total of 40 items.
State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure."
Trait anxiety items include: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person."
All items are rated on a 4-point scale (e.g., from "1=Almost Never" to 4="Almost Always") with a maximum score range of 40-160 when all 40 items are administered.
Higher scores indicate greater anxiety.
Participants will complete STAI at baseline and during clinic visit with surgeon.
Means, standard deviation, and group differences of the scores with confidence intervals will be reported.
|
1 day, during appointment immediately prior to meeting with surgeon
|
|
Mean scores on the Preparation for Decision Making (PrepDM) Scale -
大体时间：1 day, during appointment immediately prior to meeting with surgeon
|
The PrepDM is a validated 10-item tool that assesses a patient's perception of how well a decision aid or intervention, such as a decision aid, educational material, or clinical consultation, helps a patient feel prepared to make a health decision and discuss it with their practitioner.
It evaluates a patient's perceived readiness across several aspects of decision-making, including understanding available options, recognizing benefits and risks, clarifying personal values, and feeling confident about communicating with healthcare providers.
It uses a 5-point Likert scale (1=Not at all, 5=A great deal), with higher score reflecting greater perceived preparation for decision-making.
Participants will complete PrepDM at baseline and during clinic visit with surgeon.
Means, standard deviation, and group differences of the scores with confidence intervals will be reported.
|
1 day, during appointment immediately prior to meeting with surgeon
|
|
Mean scores on Reconstruction-Specific Knowledge Quiz
大体时间：1 day, during appointment immediately prior to meeting with surgeon
|
Reconstruction-specific knowledge quiz is a 7-item quiz.
It is an author-developed instrument assessing knowledge of the reconstructive options covered in the educational materials, including implant-based reconstruction, autologous reconstruction, Goldilocks reconstruction, and the option of going flat.
Participants will complete Reconstruction-Specific Knowledge Quiz at baseline and during clinic visit with surgeon.
Means, standard deviation, and group differences of the scores with confidence intervals will be reported.
|
1 day, during appointment immediately prior to meeting with surgeon
|
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：Merisa Piper, MD、University of California, San Francisco
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)
2026年6月6日
初级完成 (估计的)
2028年3月31日
研究完成 (估计的)
2029年3月31日
研究注册日期
首次提交
2026年5月11日
首先提交符合 QC 标准的
2026年5月18日
首次发布 (实际的)
2026年5月22日
研究记录更新
最后更新发布 (实际的)
2026年6月12日
上次提交的符合 QC 标准的更新
2026年6月10日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- 26754
- NCI-2026-03675 (注册表标识符：NCI Clinical Trials Reporting Program (CTRP))
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.