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

Condition(s) studied

Investigational drug(s) / intervention(s)

psychological-clinical intervention with three days of expressive writing by Pennebaker: The 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).

Study 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

Primary outcome measure(s)

• Change of Depressive symptoms — 6 months
  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 — 6 months
  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 — 6 months
  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 — 6 months
  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.
• Change of Psychological distress — 6 months
  In order to investigate the impact of oncological disease and treatment in terms of psychological distress, all participants completed Psychological Distress Inventory - PDI 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). High scores correspond to a high degree of distress perceived by the subject. We will expect lower level of distress in those who carried out clinical psychology intervention with expressive writing task.
• Change of People's Dispositional Optimism — 6 months
  In order to investigate how optimistic or pessimistic people feel about the future, all participants completed Life Orientation Test Revised - LOT-R 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). Scores range from zero to 24; higher scores indicate greater optimism and lower scores indicate lower optimism, often referred to as pessimism. We will expect higher level of optimism in those who carried out clinical psychology intervention with expressive writing task.
• Change of Hopelessness — 6 months
  In order to investigate hope for the future in the participants, the Beck Hopelessness Scale - BHS 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). Higher scores indicate the increased respondent's negative expectations for the future. We will expect lower level of negative attitudes, or pessimism, about the future in those who carried out clinical psychology intervention with expressive writing task.
• Change of Body Image — 6 months
  In order to investigate the discomfort related to the one's body image, all participants completed Body Uneasiness Test - BUT 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 ratings indicate higher levels of body uneasiness. We will expect lower level of body uneasiness in those who carried out clinical psychology intervention with expressive writing task.
• Change of Breast Cancer Core — 6 months
  In order to investigate expectations, results and experience of women undergoing breast cancer surgery, all participants completed BREAST-Q 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). We will expect greater satisfaction and better health-related quality of life in those who carried out clinical psychology intervention with expressive writing task.

Trial sites (1)

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