Ethical approval to conduct this study was granted by the Institutional Review Board of the University of L’Aquila, Italy (Prot. N° 36032/2017), and S. Salvatore Hospital of L’Aquila (Italy) (i.e. the hospital from which the participants were recruited).
Informed consent was obtained from each participant, and the study adhered to guidelines outlined in the Declaration of Helsinki .
A total of 44 30–55-year-old (mean = 40.4 ± 5.9) women participated in this study. They were living in Italy, and their education levels were as follows: high school graduate (45.5%), graduate (34.5%), and not graduated (20.5%). Further, 70.5% of them were employed.
We contacted 56 eligible patients, and 44 of them provided informed consent. Twelve patients declined the invitation to participate in the study. The participants were classified into 2 groups: a) the RS group, which consisted of 22 women who had undergone mammoplasty (mastectomy) after receiving a diagnosis of breast cancer and b) the AS group, which consisted of 22 women who had undergone mammoplasty for aesthetic reasons. RS group women have been enrolled in Oncological Division of S. Salvatore Hospital during their scheduled follow-up; A group women have been enrolled in hospital during their screening session for cancer prevention. Medical staff identified the eligible women and the recruitment was voluntary.
Eligible participants met the following inclusion criteria: a) age > 18 years, b) outpatients who have undergone breast surgery, and c) willingness to participate in the study and provide written informed consent.
The exclusion criteria were as follows: a) contraindications for mammoplasty (e.g. the presence of severe psychopathology, dysmorphic disorder, and/or severe systemic diseases), c) cancer recurrence, d) a prior diagnosis of cancer or concurrent diagnosis of another cancer, e) mastectomy after breast cancer recurrence, and f) the presence of severe chronic diseases or significant physical or psychological disabilities that could invalidate informed consent or their responses.
Table 1 presents the demographic characteristics of the participants.
Two types of data were collected. First, demographic data were collected using self-report measures. we selected independent variables for inclusion in the analyses if they were characteristic of the age/life stage (e.g. educational level, occupational and marital status). Second, clinical data were collected using psychological assessments.
The psychological measurement was conducted by the self-report questionnaire in order to detect demographic characteristics of the participants and the BREAST-Q test to evaluate the emotional impact of breast surgery.
Demographic Questionnaire. This self-report measure was used to assess the demographic characteristics of the participants (e.g. age, educational level, occupational status, time since mammoplasty, type of surgical intervention).
Italian Version of the BREAST-Q (i.e. post-operative version) . The BREAST-Q assesses the patient-reported outcomes of plastic and reconstructive breast surgery. We applied respectively subscale for both kind of surgery composed of five indexes measuring well-being and satisfaction: satisfaction with breasts, satisfaction with outcome, psychosocial well-being, sexual well-being. All subscales are scored from 0 to 100 by Rasch score. Higher scores are indicative of greater satisfaction or better functioning.
This study was conducted in collaboration with general practitioners and breast cancer specialists. They identified eligible participants, who were subsequently enrolled by appointments. Informed consent was obtained at the time of enrolment. Trained clinical psychologists, who were blinded to the objectives of the study, administered the psychological assessments in a quiet, dedicated room within the hospital. The duration of the evaluation procedure was 40 minutes. The data were collected anonymously.
The participants were divided into two groups depending on the type of breast surgery (i.e. AS vs. RS) that they had undergone and the time that had elapsed since their surgery (i.e. ≤ 3 years vs. > 3 years). Descriptive statistics were computed to examine their characteristics. With regard to continuous variables (e.g. age, scores on the BREAST-Q scales), their medians and 25th to 75th percentiles (IQRs) were ascertained. The Wilcoxon-Mann-Whitney test was used to examine between-groups differences. A χ2 analysis was performed to compare the categorical variables (age classes, geographical location, education, occupation, time after surgery) reported as counts and column percentages.
All statistical analyses were conducted using Stata (Release 15/IC, College Station, TX: Stata Corp LP). All the tests were two-tailed, and the statistical significance was defined as p < 0.05.