The prosthetic device

The CNC prosthesis is a certified (ISO 90011400018000) medical device produced by a patented process by Advihair srl. Briefly, a polymer, manufactured in-house by a proprietary method, is shaped on the mold of the patients head and colored with a biologic pigment according to her scalp skin color. Natural untreated hair with the features of the patients hair is applied by hand on the molded polymer. Specialized personnel fit the device to the head and fix it with an adhesive substance; a patch test rules out possible intolerance. The device needs sanitization once a month. A total of 21 devices were donated by Cesare Ragazzi Laboratories (Italy) to perform this study.

Patients enrolled in the study were provided with a personalized device. They wore it as long as desired and they were allowed to remove the device when satisfied with the length of hair. Application began before alopecia was induced by chemotherapy.

Enrollment was performed from October 2017 to July 2020 within the Complex Structure of Medical Oncology 1 of Fondazione IRCCS Istituto Nazionale dei Tumori of Milan. Patients with recurrent breast cancer and CIA, and meeting the following inclusion criteria were enrolled: use of a traditional wig in the previous experience of CIA, age>18years, absence of cognitive disorders, anxiety and/or depression, and willingness to apply the proposed device. A psychologist [AP] explained the study aims and procedures to the patients. Thereafter, if willing to use the prosthetic system and participate in the study, they signed a written consent form.

The patient sample was limited to 21 subjects due to the number of available devices.

The primary endpoint was to evaluate the impact of wearing the CNC prosthetic system in patients with a relapse of breast cancer with CIA on body image and psychological well-being. The secondary endpoints included satisfaction, strengths and weaknesses of the device. Both endpoints were compared with the previous use of a conventional wig.

A mixed-method approach [14] which includes a survey and a focus group was used to achieve research aims.

Survey A questionnaire was administered to all participants.

The Italian validated version of the Body Image Scale (BIS) was used to evaluate the perception of body image [15, 16]. This 10-item scale investigates affective, behavioral, and cognitive dimensions of body image in patients affected with neoplasia. The total score ranged from 0 to 30: zero scores represent no symptoms or distress; higher scores correspond to increasing symptoms and distress or more body image concerns.

The psychological well-being was assessed by the Italian version of the Psychological Well-Being Scale (PWB) [17, 18]. Answers are given on a 6-point Likert scale, and 18 items are considered. This questionnaire investigates six dimensions: autonomy, relationships, mastery of the environment, personal development, acceptance of oneself and purpose in life. Each dimension ranged from 3 to 18: the higher the score, the higher the psychological well-being.

The perception of hair was evaluated by two additional items (Hair is important to me and Hair is an important aspect of my look) concerning how important hair is to the patient and the impact on physical appearance. Each answer is given on a 5-point Likert scale, and the resulting score was considered their average: the higher the score, the higher the importance of hair.

Sociodemographic and clinical data of patients were collected. Occurrence of any discomfort with the device was also recorded.

The beginning of a new regimen of chemotherapy was the baseline. At this time, patients were required to answer the BIS by referring to their previous experience with a conventional wig, while the PWB investigated their current well-being. Assessments were repeated 3 and 6months after applying the device, asking the patient to evaluate the recent experience with both BIS and PWB.

Focus group The first 12 patients who completed the use of the device were asked to participate in the focus group. A focus group is a qualitative research technique used to deepen a theme through group interaction of people who have a common experience or characteristic [19]. A psychologist with experience in qualitative research [SA] facilitated the focus group. A semi-structured interview was used for the discussion, and the interviewer used a non-directive modality. The following topics were considered: baseline expectations regarding the device, comparison of standard wigs with the CNC device, perception and evaluation of the device, possible weaknesses and willingness to buy the device.

The scores of the perception of hair, BIS and PWB scales were calculated according to the developers indications. Descriptive statistics were applied to obtain summary results for each score by time point.

Nonparametric rank-based models for longitudinal data were used to model the time trends for each scale [20, 21]. Those models are suitable for non-Gaussian-distributed variables, are robust to outliers, and exhibit competitive performance for small sample sizes. These models allow to statistically test the null hypothesis of no time effect using an ANOVA-type test [22, 23]. As additional analysis when ANOVA-type test was significant, the WilcoxonMannWhitney exact paired test adjusted for tied values was used to compare distributions of scores at baseline versus 3months and baseline versus 6months [24].

The statistical significance level of tests was 0.05. Analysis was conducted in R [25].

Cronbach alpha values were calculated at baseline (complete data), with Bootstrap 95% CI with 2000 replications.

The focus group was audio-recorded, and transcriptions were analyzed through a paperpencil thematic analysis [26]. Thematic analysis is one of the most popular method of analyzing qualitative data. With the word theme we referred to a topic or concept that emerges throughout the text and that answer to the research aims. The themes can be articulated into sub-themes, each of them focused on specific aspects. The qualitative study followed the Consolidated criteria for reporting qualitative research (COREQ) [27].

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Evaluation of the CNC prosthetic system in recurrent breast cancer patients with chemotherapy-induced alopecia: a pilot study - BMC Women's Health -...