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

ConditionPsychological
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Roma La Sapienza

About this trial

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

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • psychological-clinical intervention with three days of expressive writing by Pennebaker

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators