Education Materials for Breast Surgery

RB
Overseen ByReta Behman, BA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, San Francisco
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests various educational materials to determine which best helps patients understand breast reconstruction options after a mastectomy (breast removal surgery). Participants will receive either written health education materials, video health education materials, a combination of both, or no extra materials before their consultation. The goal is to identify which method enhances understanding and decision-making for patients. This trial suits new UCSF patients considering a mastectomy, whether due to breast cancer, genetic risk, or other factors, and who speak English. As an unphased trial, it provides a unique opportunity for patients to contribute to improving educational resources for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these educational materials are safe for patients?

Research has shown that using videos and written materials to educate patients is generally safe. Health education videos help patients understand their medical choices and have not been linked to negative effects. These resources aim to inform, not treat, so they don't pose direct health risks.

Similarly, healthcare has long used written materials to help patients grasp complex information about their conditions and treatments. Like videos, written materials have no known side effects or safety concerns.

In summary, both video and written educational materials are safe for patients. They serve as tools to improve understanding and are not associated with direct health risks.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the impact of educational materials on patients undergoing breast surgery. Unlike standard care, which often involves verbal explanations and pamphlets, this trial tests video and written materials separately and in combination. The video modules feature expert insights delivered in an engaging format, while the comprehensive illustrated brochure offers a deep dive into reconstructive options. By using these innovative educational tools, the trial aims to enhance patient understanding and satisfaction, potentially leading to better-informed decisions and improved outcomes.

What evidence suggests that these educational materials are effective for breast surgery patients?

Research has shown that videos can greatly enhance understanding of breast cancer and assist patients in making better decisions. One study found that video lessons increased women's awareness and understanding of breast cancer treatments. Written materials also prove effective, as studies have shown they can clearly explain complex information and aid memory retention. In this trial, participants may receive video materials, written materials, or a combination of both. Combining video and written materials might further improve understanding, as different formats cater to various learning styles. These educational tools aim to equip patients with the knowledge needed to make informed choices about their breast reconstruction options.678910

Who Is on the Research Team?

MP

Merisa Piper, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults 18 or older who are new patients at UCSF considering breast reconstruction after a mastectomy, whether due to breast cancer, high genetic risk, staged procedures, or if they haven't yet decided between lumpectomy and mastectomy.

Inclusion Criteria

Presenting as a new patient to the UCSF plastic surgery breast reconstruction clinic
I am planning to have a mastectomy for my breast cancer.
I am 18 years old or older.
See 3 more

Exclusion Criteria

Established patients returning for follow-up to minimize confounding variables of individual surgeon education style on outcome measures
Non-English speakers as educational materials are currently available in English only
I am planning to have a lumpectomy or breast reduction surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Participants receive assigned educational materials (written, video, or combined) and complete surveys prior to consultation

1 day
1 visit (in-person)

Consultation

Participants meet with the plastic surgeon for consultation after reviewing educational materials

1 day
1 visit (in-person)

Follow-up

Participants' medical charts are reviewed post-consultation to assess outcomes

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Video Health Education Materials
  • Written Health Education Materials

Trial Overview

The study compares how well written materials, video materials, both together, or no extra education help patients understand their options before post-mastectomy breast reconstruction. Participants are randomly assigned to one of these groups.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Group I: Written Educational InterventionExperimental Treatment3 Interventions
Group II: Video Educational InterventionExperimental Treatment3 Interventions
Group III: No Supplemental Education / Control ArmExperimental Treatment2 Interventions
Group IV: Combined Educational InterventionExperimental Treatment4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

Citations

The Effectiveness of Educational Interventions on Breast ...

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The Comparative Effectiveness of Education Modalities on ...

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Efficacy of Written Versus Video Patient Education ...

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Education Materials for Breast Surgery · Info for Participants

The study compares how well written materials, video materials, both together, or no extra education help patients understand their options ...

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Simple Summary. Our research addresses the challenges in informed consent in postoperative radiotherapy for breast cancer.

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