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

RecruitingNAAges 18 Years - anyFemaleUniversity of Roma La Sapienza
NCT05616988 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The aim of the present study is to verify the effects of a psychological-clinical intervention supported by the technique of expressive writing, on the post-operative course in terms of mental and physical health in patients undergoing surgical mastectomy treatment with post-oncological breast reconstruction. In particular, it is hypothesised that patients undergoing psychological, emotional and social well-being in the phase following surgical treatment, together with an improvement in the inflammatory profile and a possible change in the tryptophan/kynurenine ratio and cortisol. For this purpose, the recruited patients will be randomly divided into two groups. The first experimental group will consist of 10 patients with an indication for reconstruction using autologous tissues (DIEP, FALD) and 10 patients with an indication for reconstruction using the immediate prosthesis technique

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📋 Eligibility rules (as published)
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
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What it tests

  • psychological-clinical intervention with three days of expressive writing by Pennebaker
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Where

1 site
Sant'Andrea Hospital, Faculty of Medicine and Psychology "La Sapienza'' University of Rome
Rome, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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