Clinical trial Recruiting at 1 site Interventional Ages 18 and up Women only

Evaluating the effects of expressive writing on body image after breast cancer surgery

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

Run by University of Roma La Sapienza · NCT05616988 · Data updated 2026-11-12

This study is testing if expressive writing can help improve body image and mental health for people recovering from breast cancer surgery compared to standard care.

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Quick facts

Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment80 (estimated)
SponsorUniversity of Roma La Sapienza
Academic / other
Locations1 site (Rome, Rome)
StatusRecruiting
StartedOctober 26, 2022
Main results expectedNovember 30, 2025
Study endsNovember 2026
Registry record updatedDecember 13, 2024
Trial IDNCT05616988 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are women diagnosed with breast cancer who are scheduled for surgical mastectomy and reconstruction.

Probably not a fit

Patients with metastatic disease, those refusing reconstruction, or those with existing psychopathological diagnoses may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the impact of a psychological intervention using expressive writing on the mental and physical health of patients undergoing mastectomy and breast reconstruction due to breast cancer. Participants will be randomly assigned to two groups: one receiving the expressive writing intervention and the other receiving standard care. The study will measure changes in psychological well-being, inflammatory markers, and the tryptophan/kynurenine ratio. The goal is to understand how emotional support can enhance recovery and body image perception post-surgery.

Why it matters

Potential benefit: If successful, this intervention could significantly improve the psychological well-being and body image of breast cancer patients after surgery.

How similar studies have gone: While the approach of using expressive writing in cancer care is promising, this specific application in breast cancer reconstruction is relatively novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Sant'Andrea Hospital, Faculty of Medicine and Psychology "La Sapienza'' University of Rome
    Rome, Rome, Italy
    Recruiting

Study contacts

  • Principal investigator: Carlo Lai — Department of Dynamic and Clinical Psychology, and Health Studies Sapienza University of Rome
  • Study coordinator: Carlo Lai
  • Email: carlo.lai@uniroma1.it
  • Phone: 0649917599

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.