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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
psychological-clinical intervention with three days of expressive writing by Pennebaker
Other interventionThe psychological-clinical intervention involves five interviews with three days of expressive writing by Pennebaker. During the psychological-clinical interviews the following aspects will be explored: * Emotions and expectations related to the breast reconstruction process. * Feelings related to the perception of one's own body image to promote an integration between the image of one's body and the aspects related to one's own identity and femininity. * Thoughts and feelings related to one's relational and social life. Expressive writing is a technique devised by Pennebaker (1986), who states that expressing deeper thoughts and feelings through writing can improve the physical and psychological health of the individual. The writing task consists of writing about a traumatic experience or a significant event for the person, for a controlled period (usually 15-30 minutes) and on consecutive days (from 2 to 3 days).
Treatment groups
Trial outcomes
Primary outcomes
Change of Depressive symptoms
In order to test any variation in depressive symptoms the Beck Inventory Scale - BDI was administered in the pre-operative phase (T0), on the day after the end of the clinical psychological intervention (T1) and at the 3-month (T2) and 6-month follow-ups (T3). The Scores 0-13 indicate an absence of depressive content, the scores between 14-19 a mild depression, the scores 27-29 a moderate grade depression and the scores 30-63: a severe depression. We will expect a lower level of depression in those who carried out clinical psychology intervention with expressive writing task.
Change of Anxiety Levels
In order to test any variation in anxiety levels all participants completed State-Trait Anxiety Inventory - STAI in the pre-operative phase (T0), on the day after the end of the clinical psychological intervention (T1) and at the 3-month (T2) and 6-month follow-ups (T3). The scores between 80-71 represent very high level of state and trait anxiety, 70-51 represent medium-high level, 50-31 represent medium-low level and 30-20 none or very low level. We expected lower level of anxiety in those who carried out clinical psychology intervention with expressive writing task.
Change of Alexithymia
In order to evaluate the level of alexithymia the TAS-20 will be administered in the pre-operative phase (T0), on the day after the end of the clinical psychological intervention (T1) and at the 3-month (T2) and 6-month follow-ups (T3). It is a self-administered questionnaire, consisting of 20 items. The scale ranges between 20 to 100 and it allows to identify alexithymic (\> 60), not alexithymic (\< 51) and probably alexithymic patients (51-60). We will expect lower level of difficulties in identifying, recognizing and describing emotions in those who carried out clinical psychology intervention with expressive writing task.
Change of Resilience
In order to investigate resilience, all participants completed 14-item Resilience Scale - RS-14 in the pre-operative phase (T0), on the day after the end of the clinical psychological intervention (T1) and at the 3-month (T2) and 6-month follow-ups (T3). Higher scores mean superior levels of resilience tendencies. We will expect higher level of resilience in those who carried out clinical psychology intervention with expressive writing task.
Secondary outcomes
Change of kynurenine/tryptophan ratio
Physiological parameters related to the kynurenine/tryptophan ratio will be determined in a salivary matrix and assessed by POCT.
Change of Cortisol
Physiological parameters related to the cortisol will be determined in a salivary matrix and assessed by POCT.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.