Trial Title:
Metabolomic Evaluation of Psycho-surgical Synergy on Body Image Restoration After Breast Cancer
NCT ID:
NCT05616988
Condition:
Psychological
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Mind-Body Intervention
Metabolomics
Breast Reconstruction
Body Image
Breast Cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Other
Intervention name:
psychological-clinical intervention with three days of expressive writing by Pennebaker
Description:
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).
Arm group label:
Experimental Group
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).
Detailed description:
Breast cancer is the most prevalent cancer globally and is the leading cause of cancer
death among women of any age after puberty. Often the diagnosis and treatments of this
disease coincide with a long-term worsening of psychophysical well-being, with the
following , with consequent impacts on quality-of-life. Among the different treatments,
mastectomy with breast reconstruction seems to have relevant effects on psychosocial
aspects.
Women with breast cancer show symptoms such as distress, anxiety, depression, and
hopelessness for the future, especially between the preliminary diagnosis and the
reconstruction surgery.
Furthermore, the psychological and emotional impact concomitant to the treatment pathway
can be influenced by the perception of one's body image and aspects related to sexuality.
In cancer patients, this psychological distress can be associated with neurophysiological
changes, where an acute state of stress can lead to increased cortisol levels and
stimulation of the inflammatory response, thereby increasing the release of numerous
pro-inflammatory cytokines and interleukins. All of this may influence the conversion of
the essential amino acid tryptophan and its consequent conversion to kynurenine. This
psychophysiological interaction appears to play a key role in breast cancer development,
progression, metastasis, and therapeutic outcome. Currently, there is evident the need to
include a psychological-clinical intervention, supported by the expressive writing
technique, within the treatment process for women undergoing surgical mastectomy
treatment with breast reconstruction, to bring about an increase in patients' awareness
and efficiency and improve their general health status. Moreover, the
psychological-clinical intervention could modulate the complex metabolic and inflammatory
responses of the body that characterize the oncological condition, going to improve
psychophysical well-being.
The main objective of this study is to verify the effects of a psychological-clinical
intervention supported by the expressive writing technique, on the post-operative course
in terms of mental and physical health in patients undergoing post-oncological breast
reconstruction. In particular, the present study intends to combine the evaluation of the
therapeutic process through specific psychological scales with the variations of the
phenotypic profile, based on the evaluation by Point Of Care Testing (POCT) of
physiological parameters of interest, such as the values of inflammatory markers (Serum
Amyloid A and IL-6), the tryptophan/kynurenine ratio and cortisol levels. It is
hypothesised that patients undergoing the psychological-clinical intervention improve
their psychological, emotional, and social well-being in the phase following the surgical
treatment, together with an improvement in the inflammatory profile and a possible change
in the tryptophan/kynurenine ratio and cortisol.
This study and its results will prompt an innovative multidisciplinary view of the
psychophysical well-being of the woman involved in the post-oncological reconstructive
care path. Patients' health will be pursued through the integration of the reconstructed
part of the breast which will be evaluated on a phenotypic level, general aspects taking
into account both psychological and biological ones.
80 female patients undergoing mastectomy surgery with post-oncological breast
reconstruction will be recruited at the Plastic Surgery Unit (OU) of the Sant'Andrea
Hospital, Faculty of Medicine and Psychology "La Sapienza'' University of Rome. Patients
will be required to participate voluntarily, free of charge and informed consent will be
required.
During the first consultation, the indication for the type of reconstruction (autologous
vs immediate prosthesis) will be decided on the basis of the type of mastectomy and the
characteristics of the patient.
Depending on the type of reconstruction, patients will be randomly assigned to the
following groups:
- Experimental Group A: 20 patients with indications for reconstruction using
autologous tissues (DIEP, FALD) who will carry out the psychological-clinical
intervention focused on expressive writing about their experience of surgical
treatment.
- Control Group B: 20 patients with indication for reconstruction using autologous
tissues (DIEP, FALD) who will not perform any psychological-clinical intervention.
- Experimental Group C: 20 patients with an indication for reconstruction using the
direct to implant reconstruction who will carry out the psychological-clinical
intervention focused on expressive writing about their experience of surgical
treatment.
- Control Group D: 20 patients with indication for reconstruction using the direct to
implant reconstruction who will not perform any psychological-clinical intervention.
Patients in the control group will be able to apply for the psychological-clinical
intervention at the end of the research.
In the first phase of the study, patients meeting the inclusion criteria will be
identified and ask them to sign informed consent for participation in the study. All
patients included in the study will undergo a preliminary visit before surgery where they
will receive standardised laboratory and radiologic exams needed to establish eligibility
for surgery.
Furthermore, will carry out a first measurement of the variables of interest of the
study. Measurements will include a salivary matrix sample, a blood sample and the battery
of psychological questionnaires.
Subsequently, all patients will be admitted to the department of Plastic Surgery the day
before surgery, and they will be asked to sign the informed consent for surgery and then
preoperative markings will be performed by the surgeon. The patients will be discharged
based on the type of reconstruction and the postoperative status between the 1st and 3rd
postoperative day. Finally, the patients will be randomized to double-blind research
groups (experimental and control).
In the second phase of the study, corresponding to the post-operative period, the
experimental group is scheduled for five weekly interviews interspersed with three days
of expressive writing by Pennebaker (1986).
Following the first three psychological-clinical interviews, the three days of expressive
writing will be carried out. During these days the patients of the experimental group
will be asked to write, for 20 minutes a day, their deepest emotions, thoughts, and
concerns related to the surgical treatment.
The patients of the experimental group will carry out the expressive writing session in
their homes, in a closed, silent room, which guarantees their privacy.
In the last two psychological-clinical interviews, the emotional aspects that emerged
during the three days of expressive writing will also be discussed with the patient.
No psychological-clinical intervention is envisaged for the control group, which can be
requested at the end of the research.
In addition, the concentrations of the different metabolites of the kynurenine pathway
involved in inflammatory processes and concomitant psychopathological mechanisms. In
particular, the dosages will be carried out on a salivary matrix collected immediately
before and 30 minutes after the psychological-clinical session. The results will be
normalized through the acquisition of the values of inflammation markers such as SAA and
IL-6.
The day after the end of the psychological-clinical intervention (T1) and in the various
follow-up months (T2, T3), a salivary sample and a capillary blood sample will be taken
from each patient, and will also be asked to fill out again the battery of questionnaires
previously reported.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sant'Andrea Hospital, Faculty of Medicine and Psychology "La Sapienza'' University of Rome
Address:
City:
Rome
Zip:
00189
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Fabio Santanelli Di Pompeo
Phone:
3483312278
Email:
fabio.santanelli@uniroma1.it
Contact backup:
Last name:
Maurizio Simmaco
Phone:
0633775405
Email:
maurizio.simmaco@uniroma1.it
Start date:
October 26, 2022
Completion date:
January 30, 2024
Lead sponsor:
Agency:
University of Roma La Sapienza
Agency class:
Other
Source:
University of Roma La Sapienza
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05616988
