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Study identifier: NCT05616988 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Psychological  ·  Sponsor: University of Roma La Sapienza

PhaseNA
Planned participants80
Who can joinFemale, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 who will carry out the psychological-clinical intervention focusing on expressive writing about their experience of the surgical treatment. The psychological-clinical intervention includes five interviews interspersed with three days of expressive writing by Pennebaker (1986). The writing task consists of writing about a traumatic experience or an event significant to the person, for a controlled period of time (usually 15 to 30 minutes) and on consecutive days (2 to 3 days). The second control group will consist of 10 patients with an indication for reconstruction using autologous tissues …

This description comes directly from the study's public registry record.

Talk to the study team

Carlo Lai  ·  0649917599  ·  carlo.lai@uniroma1.it

Virginia Campedelli  ·  3402793686  ·  virginia.campedelli@uniroma1.it

Always discuss trial participation with your own doctor first.

Locations (1)

Sant'Andrea Hospital, Faculty of Medicine and Psychology "La Sapienza'' University of RomeRome, Rome, ItalyRecruiting

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Source record: clinicaltrials.gov/study/NCT05616988