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Search / Trial NCT05616988

Metabolomic Evaluation of Psycho-surgical Synergy on Body Image Restoration After Breast Cancer

Launched by UNIVERSITY OF ROMA LA SAPIENZA · Nov 8, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Mind Body Intervention Metabolomics Breast Reconstruction Body Image Breast Cancer

ClinConnect Summary

This clinical trial is studying how a specific psychological support technique, called expressive writing, can help improve the mental and physical well-being of women recovering from breast cancer surgery, specifically those undergoing mastectomy and breast reconstruction. The researchers believe that writing about their experiences may help these patients feel better emotionally and may also improve their physical health by reducing inflammation in the body. Participants will be divided into two groups: one that engages in expressive writing sessions and interviews, and a control group that will not receive this support during the study.

To be eligible for this trial, participants must be women aged 65 to 74 who have been diagnosed with breast cancer and are planning to have surgery for mastectomy and reconstruction. They should have completed at least secondary school to ensure they can write effectively. Throughout the study, participants will undergo psychological evaluations and physical health assessments at different stages to see how the expressive writing affects their recovery. It’s important to note that women with advanced cancer, those who refuse reconstruction, or those with pre-existing mental health conditions will not be included in the study.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Presence of diagnosis of breast cancer
  • indication to undergo surgical mastectomy treatment
  • Italian nationality
  • level of education not lower than a secondary school diploma, ensuring sufficient writing skills.
  • Exclusion Criteria:
  • the occurrence of metastases and/or relapse during the study phase,
  • the refusal of patients to undergo reconstruction treatment
  • the presence of existing psychopathological diagnosis

About University Of Roma La Sapienza

The University of Roma La Sapienza, one of Italy's premier research institutions, is dedicated to advancing medical science and improving patient outcomes through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, the university harnesses its extensive expertise in diverse fields, including medicine, biotechnology, and public health, to conduct rigorous and ethically sound research. Committed to fostering educational excellence and promoting groundbreaking discoveries, La Sapienza actively engages in clinical trials that aim to address critical health challenges and contribute to the development of new therapeutic interventions.

Locations

Rome, , Italy

Patients applied

0 patients applied

Trial Officials

Carlo Lai

Principal Investigator

Department of Dynamic and Clinical Psychology, and Health Studies Sapienza University of Rome

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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