Evaluating Breast Cancer Patients Modesty During Radiotherapy. A Multicentric Study

Breast Cancer Clinical Trial

— MODESTY  

Official title:

Evaluating Breast Cancer Patients Modesty During Radiotherapy. A Multicentric Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05808569
• Other study ID #: 3049
• Status: Completed
• Start date: June 3, 2020
• Est. completion date: September 28, 2022

Study information

• Verified date: March 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 537
• Est. completion date: September 28, 2022
• Est. primary completion date: September 28, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion criteria

• Patients undergoing adjuvant radiotherapy for breast cancer

• Able to understand and sign informed consent

Exclusion criteria

• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Test
A specific self-test composed by 16 questions , will be administered to BC patients undergoing adjuvant RT.

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario "A.Gemelli" IRCCS	Rome	RM

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		1-5 weeks