University of California, San Francisco
San Francisco, California, 94143, United States
Location status: Recruiting
NCT Number: NCT07602374
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
San Francisco, California, 94143, United States
Location status: Recruiting
PRIMARY OBJECTIVES:
SECONDARY OBJECTIVES
OUTLINE:
Participants will be randomized into 1 of 4 groups:
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will complete health related questionnaires.
Other names: Surveys
Five-module video series
Other names: Health Education Materials
20-page illustrated brochure
Other names: Health Education Materials
Participants may have data collected from the medical record.
Other names: Chart Review
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
University of California, San Francisco
Other
Evaluating the Efficacy of Written Versus Video Patient Education Materials for Postmastectomy Breast Reconstruction Patients: Knowledge, Confidence, and Anxiety
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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