NCT06541223

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
265

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 2, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 7, 2024

Completed
Last Updated

August 7, 2024

Status Verified

July 1, 2024

Enrollment Period

6 months

First QC Date

August 2, 2024

Last Update Submit

August 2, 2024

Conditions

Breast Cancer

Keywords

Breast CancerHigh-risk healthy patientsImplant-based reconstructionMultimedia-assisted informed consent procedure

Outcome Measures

Primary Outcomes (4)

  • Evaluation of current state of anxiety

    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

    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

    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

    Collection of Reconstructive Breast Surgery Comprehension Questionnaire (minimum value: 1, maximum value: 4 - higher scores mean better understanding)

    2 weeks

Study Arms (2)

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

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 procedureOther: Multimedia video

Interventions

Standard informed consent procedureOTHER

Face-to-face informed consent procedure supported by informational brochure

Multimedia Assisted Informed Consent ProcedureStandard Informed Consent Procedure
Multimedia videoOTHER

Multimedia presentation on implant-based reconstruction

Multimedia Assisted Informed Consent Procedure

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European Institute of Oncology

Milan, 20141, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Francesca De Lorenzi, MD

    European Istitute of Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2024

First Posted

August 7, 2024

Study Start

January 2, 2024

Primary Completion

June 25, 2024

Study Completion

June 25, 2024

Last Updated

August 7, 2024

Record last verified: 2024-07

Locations

IT(1)