NCT05616988 Metabolomic Evaluation of Psycho-surgical Synergy on Body Image Restoration After Breast Cancer
| NCT ID | NCT05616988 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Roma La Sapienza |
| Condition | Psychological |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2022-10-26 |
| Primary Completion | 2025-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2022-10-26 with a primary completion date of 2025-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 (DIEP, FALD) and 10 patients with an indication for reconstruction using the immediate prosthesis technique who will not undergo any kind of psychological-clinical intervention and will be able to apply for the latter at the end of the research. In order to verify the effectiveness of the psychological-clinical intervention, the patients will undergo a psychological evaluation (anxiety, depression, alexithymia, distress, resilience, hope for the future, quality of life, body image, psychological and affective experiences related to breast reconstruction) and a survey of physiological variables (inflammatory response, ratio tryptophan/kynurenine ratio and salivary cortisol) at the various times envisaged in the study: T0 (1 month pre-surgery mastectomy with breast reconstruction), T1(the day after the end of the psychological-clinical intervention), T2 (3 months post psychological-clinical intervention) and T3 (6 months post psychological-clinical intervention).
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
Contact & Investigator
Carlo Lai
PRINCIPAL INVESTIGATOR
Department of Dynamic and Clinical Psychology, and Health Studies Sapienza University of Rome
Frequently Asked Questions
Who can join the NCT05616988 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Psychological. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05616988 currently recruiting?
Yes, NCT05616988 is actively recruiting participants. Contact the research team at carlo.lai@uniroma1.it for enrollment information.
Where is the NCT05616988 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT05616988 clinical trial?
NCT05616988 is sponsored by University of Roma La Sapienza. The principal investigator is Carlo Lai at Department of Dynamic and Clinical Psychology, and Health Studies Sapienza University of Rome. The trial plans to enroll 80 participants.