Breast CancerNCT06541223
Multimedia-assisted Informed Consent Procedure for Patients Undergoing Mastectomy and Implant-based Reconstruction
An observational study of Breast Cancer, run by European Institute of Oncology at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Standard informed consent procedure and Multimedia video
- How many people
- 265 participants
- Where
- 1 siteItaly
- Study dates
- 2 Jan 2024to 25 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing mastectomy and implant-based reconstruction (both with definitive implants and temporary prostheses or expanders)
Who may be able to join
- 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
Who cannot join
- Patients undergoing mastectomy and autologous reconstruction
- Patients who previously underwent unilateral mastectomy and implant reconstruction, requiring contralateral mastectomy
- Patients not available for e-correspondence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Standard informed consent procedure, Multimedia video
- Keywords
- Breast Cancer, High-risk healthy patients, Implant-based reconstruction, Multimedia-assisted informed consent procedure
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard informed consent procedureOther
Face-to-face informed consent procedure supported by informational brochure
Multimedia videoOther
Multimedia presentation on implant-based reconstruction
| Study group | Role | What they receive |
|---|---|---|
| Standard Informed Consent Procedure | Face-to-face informed consent procedure supported by an informational brochure approved by the hospital committee Receives: 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 Receives: Other: Standard informed consent procedure; Other: Multimedia video |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start2 Jan 2024
- Primary completion25 Jun 2024
- Study completion25 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesca De Lorenzi, MD, Principal investigator, European Istitute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06541223
- Sponsor's protocol ID
- IEO 1999
- Status last verified
- Jul 2024
- First submitted
- 2 Aug 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Multimedia-assisted Informed Consent Procedure on the Information Gain, Satisfaction and Anxiety of Patients Undergoing Mastectomy and Implant-based Reconstruction
- ClinicalTrials.gov ID
- NCT06541223
- Acronym / sponsor ID
- IEO 1999
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, High-risk healthy patients, Implant-based reconstruction, Multimedia-assisted informed consent procedure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 25 Jun 2024 (actual)
- Study completion
- 25 Jun 2024 (actual)
- First posted
- 7 Aug 2024 (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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Informed Consent Procedure | – | Other: Standard informed consent procedureFace-to-face informed consent procedure supported by an informational brochure approved by the hospital committee |
| Multimedia Assisted Informed Consent Procedure | – | Other: Standard informed consent procedure, Other: Multimedia videoFace-to-face informed consent procedure supported by an informational brochure approved by the hospital committee, followed by a multimedia presentation on implant-based reconstruction |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing mastectomy and implant-based reconstruction (both with definitive implants and temporary prostheses or expanders)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patients undergoing mastectomy and autologous reconstruction
- Patients who previously underwent unilateral mastectomy and implant reconstruction, requiring contralateral mastectomy
- Patients not available for e-correspondence
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 |
|---|---|---|
| Standard informed consent procedureFace-to-face informed consent procedure supported by informational brochure | Other | Multimedia Assisted Informed Consent Procedure, Standard Informed Consent Procedure |
| Multimedia videoMultimedia presentation on implant-based reconstruction | Other | Multimedia Assisted Informed Consent Procedure |
Primary outcome
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
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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. This study is not recruiting at the moment.
Francesca De Lorenzi, MD principal investigator
European Istitute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by European Institute of Oncology at 1 site in Italy.
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 4 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: finished, as of the sponsor's last update on 7 Aug 2024. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of current state of anxiety (time frame: 2 weeks). The study lists 4 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 7 Aug 2024.