Breast CancerMODESTYNCT05808569
Evaluating Breast Cancer Patients Modesty During Radiotherapy. A Multicentric Study
An observational study of Breast Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Patients affected by breast cancer undergo radiotherapy with bare chest and can therefore live the moments in which they undress in front of the radiation therapy technologists (RTTs) in charge of their treatment as an extremely embarrassing one. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Test
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 537 participants
- Where
- 1 siteItaly
- Study dates
- 3 Jun 2020to 28 Sep 2022
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing adjuvant radiotherapy for breast cancer
Who may be able to join
- Patients undergoing adjuvant radiotherapy for breast cancer
- Able to understand and sign informed consent
Who cannot join
- Patients with inadequate linguistic abilities and inability to express informed consent
- Patients denying informed consent
- Patients receiving palliative treatments
- Patients affected by major psychiatric disorders
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario "A.Gemelli" IRCCS
Rome, RM, 00168
About this study
Patients affected by breast cancer undergo radiotherapy with bare chest and can therefore live the moments in which they undress in front of the radiation therapy technologists (RTTs) in charge of their treatment as an extremely embarrassing one.
Furthermore, for some of these patients the relationship with their bodies has indeed changed since surgery (i.e. mutilations, scars), particularly for specific age or socio-economic groups. In this context, sub-standard care in maintaining modesty during breast cancer radiotherapy has been reported in literature, even if poorly studied. Aim of this multicentric observational study is to describe how modesty is perceived by patients undergoing radiotherapy for breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Test
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestBehavioural
A specific self-test composed by 16 questions , will be administered to BC patients undergoing adjuvant RT.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer patients undergoing radiotherapy in adjuvant setting | Not described Receives: Behavioral: Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary aim of this study is to identify patients perception of modesty during RT for breast cancer through the use of a dedicated 16 items questionnaire validated in a Delphi consensus for the purposes of this study
Measured: 1-5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start3 Jun 2020
- Primary completion28 Sep 2022
- Study completion28 Sep 2022
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 Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 537 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808569
- Sponsor's protocol ID
- 3049
- Acronym
- MODESTY
- Status last verified
- Mar 2023
- First submitted
- 2 Mar 2023
- Last updated
- 11 Apr 2023
- Results posted
- 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 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Breast Cancer Patients Modesty During Radiotherapy. A Multicentric Study
- ClinicalTrials.gov ID
- NCT05808569
- Acronym / sponsor ID
- MODESTY / 3049
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 537 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 3 Jun 2020 (actual)
- Primary completion
- 28 Sep 2022 (actual)
- Study completion
- 28 Sep 2022 (actual)
- First posted
- 11 Apr 2023 (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.
Patients affected by breast cancer undergo radiotherapy with bare chest and can therefore live the moments in which they undress in front of the radiation therapy technologists (RTTs) in charge of their treatment as an extremely embarrassing one.
Furthermore, for some of these patients the relationship with their bodies has indeed changed since surgery (i.e. mutilations, scars), particularly for specific age or socio-economic groups. In this context, sub-standard care in maintaining modesty during breast cancer radiotherapy has been reported in literature, even if poorly studied. Aim of this multicentric observational study is to describe how modesty is perceived by patients undergoing radiotherapy for breast cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients undergoing radiotherapy in adjuvant setting | – | Behavioral: Test |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing adjuvant radiotherapy for breast cancer
Key inclusion criteria (2 listed)
- Patients undergoing adjuvant radiotherapy for breast cancer
- Able to understand and sign informed consent
Key exclusion criteria (4 listed)
- Patients with inadequate linguistic abilities and inability to express informed consent
- Patients denying informed consent
- Patients receiving palliative treatments
- Patients affected by major psychiatric disorders
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 |
|---|---|---|
| TestA specific self-test composed by 16 questions , will be administered to BC patients undergoing adjuvant RT. | Behavioural | Breast cancer patients undergoing radiotherapy in adjuvant setting |
Primary outcome
Primary aim of this study is to identify patients perception of modesty during RT for breast cancer through the use of a dedicated 16 items questionnaire validated in a Delphi consensus for the purposes of this study
Time frame: 1-5 weeks
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 11 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
Not yet recruitingPhase 1
A Study to Evaluate the Effects of GDC-4198 in Combination With Letrozole, Fulvestrant, or Giredestrant in Participants With Locally Advanced or Metastatic Hormone Receptor-Positive, HER2-Negatve Breast Cancer
Advanced or Metastatic Breast Cancer
Not yet recruitingPhase 2
Netupitant/Palonosetron for Prevention of Nausea and Vomiting in Breast Cancer ADC Therapy
Breast Cancer
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-)
Not yet recruiting
Molecular Subtype-Guided Postoperative Radiotherapy for Phyllodes Tumor of the Breast
Radiotherapy, Adjuvant, Phyllodes Breast Tumor
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 2 inclusion and 4 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 11 Apr 2023. 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?
Primary aim of this study is to identify patients perception of modesty during RT for breast cancer through the use of a dedicated 16 items questionnaire validated in a Delphi consensus for the purposes of this study (time frame: 1-5 weeks). 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 11 Apr 2023.