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OpenTrials
Completed

NCT Number: NCT05808569

Evaluating Breast Cancer Patients Modesty During Radiotherapy. A Multicentric 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Fondazione Policlinico Universitario "A.Gemelli" IRCCS

Rome, RM, 00168, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Test

Behavioral

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

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

    Time frame: 1-5 weeks

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Acronym: MODESTY

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 11, 2023
Registry last updated
Apr 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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