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.
調査の概要
状態
募集
条件
詳細な説明
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
研究の種類
介入
入学 (推定)
100
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Reta Behman, BA
- 電話番号：877-827-3222
- メール：Reta.Behman@ucsf.edu
研究場所
-
-
California
-
San Francisco、California、アメリカ、94143
- 募集
- University of California, San Francisco
-
コンタクト：
- Reta Behnam-Hanona, BA
- 電話番号：877-827-3222
- メール：Reta.Behnam@ucsf.edu
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
他の名前：
20-page illustrated brochure
他の名前：
Participants may have data collected from the medical record.
他の名前：
|
|
実験的：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.
他の名前：
Participants may have data collected from the medical record.
他の名前：
Five-module video series
他の名前：
|
|
実験的：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.
他の名前：
20-page illustrated brochure
他の名前：
Participants may have data collected from the medical record.
他の名前：
Five-module video series
他の名前：
|
|
他の：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.
他の名前：
Participants may have data collected from the medical record.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean scores on the Spielberger State-Trait Anxiety Inventory (STAI), State Form
時間枠：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 -
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Merisa Piper, MD、University of California, San Francisco
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年6月6日
一次修了 (推定)
2028年3月31日
研究の完了 (推定)
2029年3月31日
試験登録日
最初に提出
2026年5月11日
QC基準を満たした最初の提出物
2026年5月18日
最初の投稿 (実際)
2026年5月22日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月12日
QC基準を満たした最後の更新が送信されました
2026年6月10日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 26754
- NCI-2026-03675 (レジストリ識別子：NCI Clinical Trials Reporting Program (CTRP))
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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