NCT05808569

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
537

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Typical duration 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

June 3, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 11, 2023

Completed
Last Updated

April 11, 2023

Status Verified

March 1, 2023

Enrollment Period

2.3 years

First QC Date

March 2, 2023

Last Update Submit

March 30, 2023

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Breast cancer patients undergoing radiotherapy in adjuvant setting

Behavioral: Test

Interventions

TestBEHAVIORAL

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

Breast cancer patients undergoing radiotherapy in adjuvant setting

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing adjuvant radiotherapy for breast cancer

You may qualify if:

  • Patients undergoing adjuvant radiotherapy for breast cancer
  • Able to understand and sign informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario "A.Gemelli" IRCCS

Rome, RM, 00168, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

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

Study Record Dates

First Submitted

March 2, 2023

First Posted

April 11, 2023

Study Start

June 3, 2020

Primary Completion

September 28, 2022

Study Completion

September 28, 2022

Last Updated

April 11, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)