Evaluating the Efficacy of Written Versus Video Patient Education Materials for Postmastectomy Breast Reconstruction Patients: Knowledge, Confidence, and Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Medical Chart Review (Other)
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.
干预措施: Questionnaires (Other)
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.
干预措施: Video Health Education Materials (Other)
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.
干预措施: Medical Chart Review (Other)
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.
干预措施: Questionnaires (Other)
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.
干预措施: Video Health Education Materials (Other)
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.
干预措施: Written Health Education Materials (Other)
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.
干预措施: Medical Chart Review (Other)
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.
干预措施: Questionnaires (Other)
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.
干预措施: Medical Chart Review (Other)
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.
干预措施: Questionnaires (Other)
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.
干预措施: Written Health Education Materials (Other)