Multimedia-assisted Informed Consent Procedure for Patients Undergoing Mastectomy and Implant-based Reconstruction

August 2, 2024 updated by: European Institute of Oncology

Effect of a Multimedia-assisted Informed Consent Procedure on the Information Gain, Satisfaction and Anxiety of Patients Undergoing Mastectomy and Implant-based Reconstruction

Breast reconstruction is a women's right with positive psychological effects and it is an integral part of breast cancer treatment and care. A preoperative counselling is mandatory, providing information about oncologic surgery, the type of reconstruction and the expected results. This study plans to compare conventional informed consent process supported by informational brochures with a multimedia video-assisted procedure supported by the same informational brochures in breast cancer patients undergoing immediate implant-based reconstruction. The two processes will be compared in terms of information retention, patient satisfaction of the informed consent process and anxiety levels before surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Implant-based reconstruction is the most frequent procedure after mastectomy, able to preserve body integrity and femininity. Breast reconstruction is a women's right with positive psychological effects. It is an integral part of breast cancer treatment and care, and in the vast majority of cases it is performed in the immediate setting. Breast reconstruction is personalized and tailored to each patient, taking in consideration patient anatomy and comorbidities, cancer staging and oncologic rules and even patient desires. Patient expectations are very high and women are seeking for outstanding cosmetic results especially in case of prophylactic surgery, therefore preoperative counselling is mandatory, providing information about oncologic surgery, the type of reconstruction and the expected results. A detailed informed consent procedure must include explanations of the surgical procedure, including its benefits, alternatives and risks, information about the implants (temporary or definitive ones) and postoperative scenarios. The face-to-face discussion is supported by information brochures that include all this information. Unfortunately, the readability of these documents is often not high and the rate of information retention might be low. Recently, it has been observed that the amount of information retained by patients appears to improve using a multi-media video-assisted informed consent procedure. Aim of this study is to evaluate if a multimedia-assisted video tutorial before implant-based reconstruction could increase the information retained by patients, their satisfaction about the informed consent process and influence their anxiety levels before surgery.

Study Type

Observational

Enrollment (Actual)

265

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20141
        • European Institute of Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients undergoing mastectomy and implant-based reconstruction (both with definitive implants and temporary prostheses or expanders)

Description

Inclusion Criteria:

  • Patients undergoing mastectomy for breast cancer
  • High-risk healthy patients undergoing risk reducing mastectomies
  • Unilateral and/or bilateral mastectomies
  • If unilateral mastectomy, both patients requiring or not contralateral mammaplasty of the healthy breast

Exclusion Criteria:

  • Patients undergoing mastectomy and autologous reconstruction
  • Patients who previously underwent unilateral mastectomy and implant reconstruction, requiring contralateral mastectomy
  • Patients not available for e-correspondence

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Standard Informed Consent Procedure
Face-to-face informed consent procedure supported by an informational brochure approved by the hospital committee
Other: Standard informed consent procedure
Face-to-face informed consent procedure supported by informational brochure
Multimedia Assisted Informed Consent Procedure
Face-to-face informed consent procedure supported by an informational brochure approved by the hospital committee, followed by a multimedia presentation on implant-based reconstruction
Other: Standard informed consent procedure
Face-to-face informed consent procedure supported by informational brochure
Other: Multimedia video
Multimedia presentation on implant-based reconstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of current state of anxiety
Time Frame: 2 weeks
Collection of Spielberger State/Trait Anxiety Inventory (STAI) Y1 questionnaire (minimum value: 1, maximum value: 4 - higher scores mean greater anxiety)
2 weeks
Evaluation of anxiety proneness
Time Frame: 2 weeks
Collection of Spielberger State/Trait Anxiety Inventory (STAI) Y2 questionnaire (minimum value: 1, maximum value: 4 - higher scores mean greater anxiety)
2 weeks
Evaluation of uncertainty and perceptions of effective decision-making
Time Frame: 2 weeks
Collection of Decisional Conflict Scale (DCS) questionnaire (minimum value: 1, maximum value: 5 - higher scores mean higher decisional conflict)
2 weeks
Evaluation of patients' understanding of plastic reconstruction procedures and surgical complications
Time Frame: 2 weeks
Collection of Reconstructive Breast Surgery Comprehension Questionnaire (minimum value: 1, maximum value: 4 - higher scores mean better understanding)
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Institute of Oncology

Investigators

  • Principal Investigator: Francesca De Lorenzi, MD, European Istitute of Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2024

Primary Completion (Actual)

June 25, 2024

Study Completion (Actual)

June 25, 2024

Study Registration Dates

First Submitted

August 2, 2024

First Submitted That Met QC Criteria

August 2, 2024

First Posted (Actual)

August 7, 2024

Study Record Updates

Last Update Posted (Actual)

August 7, 2024

Last Update Submitted That Met QC Criteria

August 2, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IEO 1999

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe