MODESTY: Evaluating Breast Cancer Patients Modesty During Radiotherapy. A Multicentric Study

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)

Overall Status

Completed

CT.gov ID

NCT05808569

Collaborator

(none)

537

Enrollment

Location

27.8

Actual Duration (Months)

19.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Behavioral: Test

Study Design

Study Type:

Observational

Actual Enrollment :

537 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Evaluating Breast Cancer Patients Modesty During Radiotherapy. A Multicentric Study

Actual Study Start Date :

Jun 3, 2020

Actual Primary Completion Date :

Sep 28, 2022

Actual Study Completion Date :

Sep 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
Breast cancer patients undergoing radiotherapy in adjuvant setting	Behavioral: Test A specific self-test composed by 16 questions , will be administered to BC patients undergoing adjuvant RT.

Arm

Intervention/Treatment

Breast cancer patients undergoing radiotherapy in adjuvant setting

Behavioral: Test

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

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione Policlinico Universitario "A.Gemelli" IRCCS	Rome	RM	Italy	00168

Sponsors and Collaborators

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

ClinicalTrials.gov Identifier:

NCT05808569

Other Study ID Numbers:

3049

First Posted:

Apr 11, 2023

Last Update Posted:

Apr 11, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Apr 11, 2023