Breast SurgeryNCT07602374
Efficacy of Written Versus Video Patient Education Materials for Postmastectomy Breast Reconstruction
A study testing Questionnaires, Video Health Education Materials and Written Health Education Materials in people with Breast Surgery, run by University of California, San Francisco at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Surgery
- What is being tested?
- Questionnaires, Video Health Education Materials and Written Health Education Materials
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2026to 31 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Reta Behnam-Hanona, BA, 877-827-3222, Reta.Behnam@ucsf.edu
About this study
Official title: 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.
Read the detailed description
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
- 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
- Conditions
- Breast Surgery
- Being tested
- Questionnaires, Video Health Education Materials, Written Health Education Materials, Medical Chart Review
- Keywords
- Health Education
- Medical subject headings
- Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Also called Surveys
Participants will complete health related questionnaires.
Video Health Education MaterialsOther
Also called Health Education Materials
Five-module video series
Written Health Education MaterialsOther
Also called Health Education Materials
20-page illustrated brochure
Medical Chart ReviewOther
Also called Chart Review
Participants may have data collected from the medical record.
| Study group | Role | What they receive |
|---|---|---|
| Written Educational Intervention | Experimental | 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. Receives: Other: Questionnaires; Other: Written Health Education Materials; Other: Medical Chart Review |
| Video Educational Intervention | Experimental | 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. Receives: Other: Questionnaires; Other: Video Health Education Materials; Other: Medical Chart Review |
| Combined Educational Intervention | Experimental | 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. Receives: Other: Questionnaires; Other: Video Health Education Materials; Other: Written Health Education Materials; Other: Medical Chart Review |
| No Supplemental Education / Control Arm | Other | 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. Receives: Other: Questionnaires; Other: Medical Chart Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean scores on the Spielberger State-Trait Anxiety Inventory (STAI), State Form
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.
Measured: 1 day, during appointment immediately prior to meeting with surgeon
Mean scores on the Preparation for Decision Making (PrepDM) Scale -
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.
Measured: 1 day, during appointment immediately prior to meeting with surgeon
Mean scores on Reconstruction-Specific Knowledge Quiz
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.
Measured: 1 day, during appointment immediately prior to meeting with surgeon
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start6 Jun 2026
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast SurgeryStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Merisa Piper, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07602374
- Sponsor's protocol ID
- 26754
- Other IDs
- NCI-2026-03675
- Status last verified
- Jun 2026
- First submitted
- 11 May 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Written Versus Video Patient Education Materials for Postmastectomy Breast Reconstruction Patients: Knowledge, Confidence, and Anxiety
- ClinicalTrials.gov ID
- NCT07602374
- Acronym / sponsor ID
- 26754
- Conditions
- Breast Surgery
- Keywords
- Health Education
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 6 Jun 2026 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- 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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Written Educational Intervention | Experimental | Other: Questionnaires, Other: Written Health Education Materials, Other: Medical Chart ReviewOn 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. |
| Video Educational Intervention | Experimental | Other: Questionnaires, Other: Video Health Education Materials, Other: Medical Chart ReviewOn 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. |
| Combined Educational Intervention | Experimental | Other: Questionnaires, Other: Video Health Education Materials, Other: Written Health Education Materials, Other: Medical Chart ReviewOn 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. |
| No Supplemental Education / Control Arm | Other | Other: Questionnaires, Other: Medical Chart ReviewOn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesAlso: SurveysParticipants will complete health related questionnaires. | Other | Combined Educational Intervention, No Supplemental Education / Control Arm, Video Educational Intervention, Written Educational Intervention |
| Video Health Education MaterialsAlso: Health Education MaterialsFive-module video series | Other | Combined Educational Intervention, Video Educational Intervention |
| Written Health Education MaterialsAlso: Health Education Materials20-page illustrated brochure | Other | Combined Educational Intervention, Written Educational Intervention |
| Medical Chart ReviewAlso: Chart ReviewParticipants may have data collected from the medical record. | Other | Combined Educational Intervention, No Supplemental Education / Control Arm, Video Educational Intervention, Written Educational Intervention |
Primary outcome
Mean scores on the Spielberger State-Trait Anxiety Inventory (STAI), State Form
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.
Mean scores on the Preparation for Decision Making (PrepDM) Scale -
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.
Mean scores on Reconstruction-Specific Knowledge Quiz
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Merisa Piper, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires, Video Health Education Materials and Written Health Education Materials in people with Breast Surgery, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reta Behman, BA (877-827-3222, Reta.Behman@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean scores on the Spielberger State-Trait Anxiety Inventory (STAI), State Form (time frame: 1 day, during appointment immediately prior to meeting with surgeon). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.