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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Sant'Andrea Hospital, Faculty of Medicine and Psychology La Sapienza'' University of Rome
RECRUITING
Rome
Contact Information
Primary
Carlo Lai
carlo.lai@uniroma1.it
0649917599
Backup
Virginia Campedelli
virginia.campedelli@uniroma1.it
3402793686
Time Frame
Start Date: 2022-10-26
Estimated Completion Date: 2026-11
Participants
Target number of participants: 80
Treatments
Experimental: Experimental Group
The experimental group will consist of 20 patients with an indication for reconstruction using autologous tissues (DIEP, FALD) and 20 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.
No_intervention: Control Group
The control group will consist of 20 patients with an indication for reconstruction using autologous tissues (DIEP, FALD) and 20 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.
Related Therapeutic Areas
Sponsors
Leads: University of Roma La Sapienza

This content was sourced from clinicaltrials.gov