Actively Recruiting
Metabolomic Evaluation of Psycho-surgical Synergy on Body Image Restoration After Breast Cancer
Led by University of Roma La Sapienza · Updated on 2024-12-13
80
Participants Needed
1
Research Sites
209 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Metabolomic Evaluation of Psycho-surgical Synergy on Body Image Restoration After Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of breast cancer
- Scheduled to undergo surgical mastectomy treatment
- Italian nationality
- At least a secondary school diploma ensuring sufficient writing skills
You will not qualify if you...
- Presence of metastases or relapse during the study phase
- Refusal to undergo reconstruction treatment
- Existing psychopathological diagnosis
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sant'Andrea Hospital, Faculty of Medicine and Psychology "La Sapienza'' University of Rome
Rome, Rome, Italy, 00189
Actively Recruiting
Research Team
C
Carlo Lai
CONTACT
V
Virginia Campedelli
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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