Support for Chronic Pain Management for Breast Cancer Survivors Through Novel Digital Health Ecosystems: Pilot Usability Study of the PainRELife Mobile App.

BACKGROUND: Chronic pain is one of the most common and critical long-term effects of breast cancer. Digital health technologies enhance the management of chronic pain by monitoring physical and psychological health status and supporting pain self-management and patient treatment decisions throughout the clinical pathway. OBJECTIVE: This pilot study aims to evaluate patients' experiences, including usability, with a novel digital integrated health ecosystem for chronic pain named PainRELife. The sample included patients with breast cancer during survivorship. The PainRELife ecosystem comprises a cloud technology platform interconnected with electronic health records and patients' devices to gather integrated health care data. METHODS: We enrolled 25 patients with breast cancer (mean age 47.12 years) experiencing pain. They were instructed to use the PainRELife mobile app for 3 months consecutively. The Mobile Application Rating Scale (MARS) was used to evaluate usability. Furthermore, pain self-efficacy and participation in treatment decisions were evaluated. The study received ethical approval (R1597/21-IEO 1701) from the Ethical Committee of the European Institute of Oncology. RESULTS: The MARS subscale scores were medium to high (range: 3.31-4.18), and the total app quality score was 3.90. Patients with breast cancer reported reduced pain intensity at 3 months, from a mean of 5 at T0 to a mean of 3.72 at T2 (P=.04). The total number of times the app was accessed was positively correlated with pain intensity at 3 months (P=.03). The engagement (P=.03), information (P=.04), and subjective quality (P=.007) subscales were positively correlated with shared decision-making. Furthermore, participants with a lower pain self-efficacy at T2 (mean 40.83) used the mobile app more than participants with a higher pain self-efficacy (mean 48.46; P=.057). CONCLUSIONS: The data collected in this study highlight that digital health technologies, when developed using a patient-driven approach, might be valuable tools for increasing participation in clinical care by patients with breast cancer, permitting them to achieve a series of key clinical outcomes and improving quality of life. Digital integrated health ecosystems might be important tools for improving ongoing monitoring of physical status, psychological burden, and socioeconomic issues during the cancer survivorship trajectory. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/41216.

Usability Testing of a New Digital Integrated Health Ecosystem (PainRELife) for the Clinical Management of Chronic Pain in Patients With Early Breast Cancer: Protocol for a Pilot Study.

BACKGROUND: Chronic pain (CP) and its management are critical issues in the care pathway of patients with breast cancer. Considering the complexity of CP experience in cancer, the international scientific community has advocated identifying cutting-edge approaches for CP management. Recent advances in the field of health technology enable the adoption of a novel approach to care management by developing integrated ecosystems and mobile health apps. OBJECTIVE: The primary end point of this pilot study is to evaluate patients' usability experience at 3 months of a new digital and integrated technological ecosystem, PainRELife, for CP in a sample of patients with breast cancer. The PainRELife ecosystem is composed of 3 main technological assets integrated into a single digital ecosystem: Fast Healthcare Interoperability Resources-based cloud platform (Nu platform) that enables care pathway definition and data collection; a big data infrastructure connected to the Fast Healthcare Interoperability Resources server that analyzes data and implements dynamic dashboards for aggregate data visualization; and an ecosystem of personalized applications for patient-reported outcomes collection, digital delivery of interventions and tailored information, and decision support of patients and caregivers (PainRELife app). METHODS: This is an observational, prospective pilot study. Twenty patients with early breast cancer and chronic pain will be enrolled at the European Institute of Oncology at the Division of Medical Senology and the Division of Pain Therapy and Palliative Care. Each patient will use the PainRELife mobile app for 3 months, during which data extracted from the questionnaires will be sent to the Nu Platform that health care professionals will manage. This pilot study is nested in a large-scale project named "PainRELife," which aims to develop a cloud technology platform to interoperate with institutional systems and patients' devices to collect integrated health care data. The study received approval from the Ethical Committee of the European Cancer Institute in December 2021 (number R1597/21-IEO 1701). RESULTS: The recruitment process started in May 2022 and ended in October 2022. CONCLUSIONS: The new integrated technological ecosystems might be considered an encouraging affordance to enhance a patient-centered approach to managing patients with cancer. This pilot study will inform about which features the health technological ecosystems should have to be used by cancer patients to manage CP. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/41216.

Knowledge and attitudes towards clinical trials among women with ovarian cancer: results of the ACTO study.

BACKGROUND: Despite several initiatives by research groups, regulatory authorities, and scientific associations to engage citizens/patients in clinical research, there are still obstacles to participation. Among the main discouraging aspects are incomplete understanding of the concepts related to a clinical trial, and the scant, sometimes confused, explanations given. This observational, cross-sectional multicenter study investigated knowledge, attitudes and trust in clinical research. We conducted a survey among women with ovarian cancer at their first follow-up visit or first therapy session, treated in centers belonging to the Mario Negri Gynecologic Oncology (MaNGO) and Multicenter Italian Trials in Ovarian Cancer (MITO) groups. A questionnaire on knowledge, attitudes and experience was assembled ad hoc after a literature review and a validation process involving patients of the Alliance against Ovarian Cancer (ACTO). RESULTS: From 25 centers 348 questionnaire were collected; 73.5% of responders were 56 years or older, 54.8% had a high level of education, more than 80% had no experience of trial participation. Among participants 59% knew what clinical trials were and 71% what informed consent was. However, more than half did not know the meaning of the term randomization. More than half (56%) were in favor of participating in a clinical trial, but 35% were not certain. Almost all responders acknowledged the doctor's importance in decision-making. Patients' associations were recognized as having a powerful role in the design and planning of clinical trials. CONCLUSIONS: This study helps depict the knowledge and attitudes of women with ovarian cancer in relation to clinical trials, suggesting measures aimed at improving trial "culture", literacy and compliance, and fresh ways of communication between doctors and patients.

Quality of life and psycho-emotional wellbeing in bladder cancer patients and their caregivers: a comparative analysis between urostomy versus ileal orthotopic neobladder.

BACKGROUND: The impact of neobladder and urostomy on bladder cancer patient's health-related quality of life (HR-QoL) is controversial and many issues currently remain under-investigated. Initial studies pointed out that the emotional responses of caregivers might be 'contagious', influencing emotional reactions in bladder cancer patients undergoing radical cystectomy. METHODS: Three hundred and eighty-two bladder cancer patients (aged M = 67.29 years; SD = 9.23) (16.9% (65) were female and 82.9% (319) were male) and their caregivers were enrolled. Data were collected prospectively: at T0 (1 month before the surgery), at T1 (2 weeks after the surgery, at patient discharge from the hospital) and at T2 (6-month follow-up). At each time point (T0, T1 and T2), a set of questionnaires (EORT QLQ-C30 and emotion thermometer) were given to patients and their caregivers. RESULTS: All patients reported a general improvement in the HR-QoL and global health status/QoL from T0 to T2 (p < 0.001). No significant differences were observed between neobladder and urostomy. At T0, the emotional thermometer total scoring in caregivers was positive in relation to HR-QoL (p < 0.001) and negative in relation to the patient's perception of QoL (p < 0.001) and global health (p < 0.001). Similar trends were observed at T1 and T2. CONCLUSIONS: These results suggest that patients and their caregiver's emotional reactions to cancer are deep-rooted and strongly interconnected, and they provide innovative insights for the clinical management of bladder cancer patients.

The clinical-care focused psychological interview (CLiC): a structured tool for the assessment of cancer patients' needs.

Integrating the psychosocial perspective in oncology is warranted. Here, we introduce a structured psychological intervention, the clinical-care focused psychological interview (CLiC), to address patients' needs in the relationship with health professionals, clinical pathway and decision-making process. The perceived utility and feasibility of the CLiC were evaluated in a preliminary sample of 30 patients who were candidates to undergo a radical cystectomy at the European Institute of Oncology, Milan, Italy. Patients reported a very high satisfaction with the interview, because it prepared them for their upcoming surgery by gathering more information about their clinical pathway and allowed them to discover the information they still needed. 30% stated that CLiC helped them to reorganise their thoughts and 36.7% understood the role of psychological intervention in the clinical pathway. Only 20% considered the CLiC useful in helping to build their relationship with the clinical staff. Before an invasive surgery such as radical cystectomy, patients' need for information regarding the upcoming surgery seems to prevail. Knowing the future consequences and adjusting toward the disease could be paramount for patients in facing uncertainty and they might feel that creating a relationship with physicians could be a secondary issue. However, our data show that a structured psychological intervention such as the CLiC interview can collect important information for patients and healthcare professionals to develop real patient-centred care.

Patients Living With Breast Cancer During the Coronavirus Pandemic: The Role of Family Resilience, Coping Flexibility, and Locus of Control on Affective Responses.

The coronavirus disease 2019 (COVID-19) pandemic has strongly affected oncology patients. Many screening and treatment programs have been postponed or canceled, and such patients also experience fear of increased risk of exposure to the virus. In many cases, locus of control, coping flexibility, and perception of a supportive environment, specifically family resilience, can allow for positive emotional outcomes for individuals managing complex health conditions like cancer. This study aims to determine if family resilience, coping flexibility, and locus of control can mitigate the negative affect caused by the pandemic and enhance positive affect in breast cancer patients. One hundred and fifty-four female patients with breast cancer completed the Walsh's Family Resilience Questionnaire, the Perceived Ability to Cope With Trauma Scale, the Positive-Negative Affect Schedule, and the Mini Locus of Control Scale. Family resilience and internality of locus of control contribute significantly to positive affective responses. Family resilience is responsible for mitigating the negative affect perceived during the pandemic and is enhanced by external locus of control. Evidence suggests that clinical psychologists should develop and propose programs to support oncology patients' family resilience, coping flexibility, and internal locus of control, allowing for decreased stress and improved adaptability for effectively managing cancer treatment during the pandemic.

Memories of paternal relations are associated with coping and defense mechanisms in breast cancer patients: an observational study.

BACKGROUND: Breast cancer diagnosis and treatment represent stressful events that demand emotional adjustment, thus recruiting coping strategies and defense mechanisms. As parental relations were shown to influence emotion regulation patterns and adaptive processes in adulthood, the present study investigated whether they are specifically associated to coping and defense mechanisms in patients with breast cancer. METHODS: One hundred and ten women hospitalized for breast cancer surgery were administered questionnaires assessing coping with cancer, defense mechanisms, and memories of parental bonding in childhood. RESULTS: High levels of paternal overprotection were associated with less mature defenses, withdrawal and fantasy and less adaptive coping mechanisms, such as hopelessness/helplessness. Low levels of paternal care were associated with a greater use of repression. No association was found between maternal care, overprotection, coping and defense mechanisms. Immature defenses correlated positively with less adaptive coping styles, while mature defenses were positively associated to a fighting spirit and to fatalism, and inversely related to less adaptive coping styles. CONCLUSIONS: These data suggest that paternal relations in childhood are associated with emotional, cognitive, and behavioral regulation in adjusting to cancer immediately after surgery. Early experiences of bonding may constitute a relevant index for adaptation to cancer, indicating which patients are at risk and should be considered for psychological interventions.

Stress Exposure in Significant Relationships Is Associated with Lymph Node Status in Breast Cancer.

OBJECTIVE: Life stress exposure may impact on health and disease. Previous literature showed that stressful life events are associated with cancer incidence, survival and mortality. In animal models, patterns of maternal care have been shown to critically affect stress sensitivity and immunity trajectories later in life, by modifying DNA methylation during critical periods early in life. However, the role of parental care in breast cancer progression and survival has only limitedly been explored. Here, we investigated whether these factors may be linked to biological prognostic variables. METHODS: One hundred twenty-three women hospitalized for surgery of primary breast cancer completed a questionnaire assessing parental bonding. Stressful events throughout the life span were also assessed. RESULTS: We found that the absence of optimal parental relationships is significantly associated with an increased risk of lymph node involvement, adjusting for confounders, while cumulative stress in the area of sentimental relationships is borderline significantly associated with the same prognostic factor. CONCLUSIONS: Our results suggest that parental bonding and sentimental relations may have a role in breast cancer progression. These variables represent an important evolutionary aspect which may modulate cancer progression through psycho-physiological stress pathways and influence the immune system.

Nipple-sparing mastectomy--is it worth the risk?

Nipple-sparing mastectomy (NSM) is a surgical protocol designed to reduce the disabling psychological effects of radical or skin-sparing mastectomy. The preservation of the nipple-areola complex produces a more-natural result of the breast reconstruction, but this preservation is suspected of increasing tumor local recurrence. To reduce this risk, different approaches have been proposed: restrict the inclusion criteria and/or add localized radiation therapy. The local recurrence rate in recent series of patients receiving NSM is comparable with the local recurrence rate in modified radical or skin-sparing mastectomies. Today, the quality of the subcutaneous mastectomy technique allows for a more radical glandular removal, especially in the retroareolar area; therefore, local recurrence is observed in 3-6% of patients at 5 years, consistent with traditional mastectomy.

No impact of central venous insertion site on oncology patients' quality of life and psychological distress. A randomized three-arm trial.

PURPOSE: Though totally implantable access ports (TIAP) are extensively used, information from randomized trials about the impact of insertion site on patient's quality of life (QoL) and psychological distress is unavailable. PATIENTS AND METHODS: Four hundred and three patients eligible for receiving intravenous chemotherapy for solid tumours were randomly assigned to implantation of a single type of TIAP, either through a percutaneous landmark access to the internal jugular or an ultrasound-guided access to the subclavian or a surgical cut-down access through the cephalic vein at the deltoid-pectoralis groove. Patients' QoL and psychological distress were investigated at regular intervals by means of EORTC QLQ-C30 and HADS (Hospital Anxiety and Depression Scale) questionnaires, using univariate and multivariate repeated measure linear mixed models. A post hoc analysis investigated the impact of type of administered chemotherapy (adjuvant vs palliative). RESULTS: Three hundred and eighty-four patients (95.2%) were evaluable, 126 with the internal jugular, 132 with the subclavian and 126 with the cephalic vein access. The median follow-up was 361 days (range, 0-1,087). Mean score changes for the items of the EORTC QLQ-C30 scales were significantly associated with type of administered chemotherapy only (P < 0.001), and not with implantation site. Frequency distribution of patients with depression and anxiety score greater than 10 at HADS was not significantly different, with respect either to type of administered chemotherapy or TIAP implantation site. CONCLUSION: Central venous insertion sites had no impact on patients' QoL and psychological distress. Patients undergoing palliative therapies showed worse EORTC QLQ-C30 scales.

A psychosocial cancer phone center staffed by professional psychologists as an integral part of the standard process of care: Its utility during the course of illness.

OBJECTIVE: Major cancer centers cannot ignore psychosocial patient needs that have a significant impact on the process of adjustment to cancer and on compliance to treatments. We introduced a new service, the Gigi Ghirotti Psychosocial Cancer Phone Center (GGPCPC), staffed by professional psychologists, for use by our patients and their relatives. This article investigates its feasibility as a support delivery vehicle for patients in their follow-up phase, and also investigates patients' sense of abandonment related to their care setting. METHOD: A close collaboration was set up between GGPCPC psychologists and European Institute of Oncology (IEO) psychologists. Education and awareness sessions regarding the importance of such a source of psychological support were conducted by IEO psychologists with nurses, secretaries, and receptionists. IEO psychologists input monthly data, recorded on specific paper-tabs by GGPCPC psychologists for each call received by the phone center between March 2007 and March 2009, into a SPSS database. RESULTS: Four hundred and thirty individuals contacted the center mainly to receive psychological support during their treatment phase, when they visited IEO for treatment sessions. Multiple indicators suggest that this telephone support program was feasible and provided support to a broad range of cancer patients. Patients seemed to prefer it to face-to-face psychological support during their treatment-phase. SIGNIFICANCE OF RESULTS: The GGPCPC was demonstrated to be an efficacious support and information delivery vehicle for patients and relatives during the illness course.

Impact of medical discipline and observer gender on cosmetic outcome evaluation in breast reconstruction using transverse rectus abdominis myocutaneous (TRAM) flap and radiotherapy.

BACKGROUND: Despite the complication rate, the majority of studies report a satisfactory cosmetic outcome in patients undergoing transverse rectus abdominis myocutaneous (TRAM) flap breast reconstruction both before and after radiotherapy (RT). The lack of a universal agreement on the use of a validated scale for cosmetic assessment in clinical practise leads to subjective criteria of evaluation and causes a great deal of interobserver variability. This study investigates whether there is any difference in the evaluation of cosmesis according to gender and specialisation of the observer. METHODS: Fifty-two photographs of the patients who had undergone TRAM reconstruction for breast cancer, divided into three groups according to the treatment (TRAM only, TRAM→RT, RT→TRAM), were evaluated by 21 specialists, 10 male and 11 female from radiotherapy, breast surgery and plastic reconstructive surgery. Cosmetic outcome was classified using the four-category Harvard scale: a score of excellent/good was considered acceptable. RESULTS: The overall rate of good/excellent ratings was 66.6%, which was lower than the score reported in the literature. A significantly worse score was registered in the TRAM→RT group compared with the other groups. The probability for male physicians to award a positive judgement is 24% higher than that of female ones. In general, there is a decent agreement among the judgement raters. CONCLUSIONS: No statistically significant difference in cosmetic evaluation was noted overall between male physicians and female ones. However, within each specialisation, the difference between the two genders was great. Breast surgeons gave the worst opinion, and among them female surgeons judged most severely, whereas plastic surgeons gave the best opinion, and among them females provided the highest favourable judgement.

Does a personalized approach improve patient satisfaction in thoracic oncology?

OBJECTIVE: To evaluate patients' quality of life (QOL) at admission to permit definition and implementation of a personalized plan of multidimensional care. METHODS: In 2007, patients hospitalized for more than 24 hours at the Thoracic Surgery Department of a tertiary referral cancer center received QOL assessment at admission by European Organisation for Research and Treatment of Cancer (EORTC) questionnaires QLQ-C30 and LC13. Patients were asked to anonymously express their satisfaction with care at discharge by using the EORTC IN-PATSAT32 questionnaire. During the second part of the study (July-December 2007), specific interventions were proposed in critical areas identified by the questionnaires. RESULTS: During 2007, 898 patients completed QOL assessment at admission and 805 patients anonymously expressed their satisfaction with care at discharge. Overall patient satisfaction significantly improved in the second part of the study (85.4 +/- 16.7 vs 91.9 +/- 13.1; P = .009). The most significant improvement was recorded in nurses' information provision (67.7 +/- 24.1 vs 80.2 +/- 20.2; P = .0014) and availability (70.4 +/- 22.8 vs 84.3 +/- 19.2; P <.001). Surprisingly, the third-ranking improvement was recorded for the hospital access scale, which was the item with the lowest score in both periods and for which no specific modification occurred during the study period. CONCLUSIONS: Use of a simple and reliable evaluation of QOL at admission contributed to improved quality of administered care. This approach permits focused management of ongoing problems, close cooperation between caregivers, and a more flexible response to patient needs.

A double-blind, randomised, vehicle-controlled clinical study to evaluate the efficacy of MAS065D in limiting the effects of radiation on the skin: interim analysis.

Our aim was to assess the efficacy of MAS065D, a non-steroidal water-in-oil cream, in preventing and limiting skin reactions caused by radiation therapy (RT). 40 women treated with conservative breast cancer surgery followed by radiotherapy, were randomised to receive MAS065D (22 pts) or vehicle (18 pts). Radiotherapy was delivered in 20 fractions: 2.25 Gy to the whole breast plus a concomitant boost of 0.25 Gy to the tumour bed up to a total dose of 50 Gy. Evaluations of skin toxicity, erythema, and subjective symptoms were carried out weekly and 3 weeks after treatment completion. A statistically significant difference between vehicle and MAS065D groups was recorded regarding the maximum severity of skin toxicity (p < 0.0001), burning within the radiation field (p = 0.039) and desquamation (p = 0.02), in favour of the latter. We conclude that MAS065D may be considered a safe and effective treatment in the prevention and minimization of skin reactions and associated symptoms.

Nipple-sparing mastectomy in association with intra operative radiotherapy (ELIOT): A new type of mastectomy for breast cancer treatment.

BACKGROUND: Breast-conserving surgery has become the standard approach for about 80% of patients treated for primary breast cancer in most centres. However, mastectomy is still required in case of multicentric and/or large tumours or where recurrences occur after conservative treatment. When a total mastectomy is performed, the removal of the nipple areola complex (NAC) is a strongly debated issue. In fact, although removal of the NAC greatly increases the patient's sensation of mutilation, and the risk of tumor involvement of the areola is reported as a very variable percentage, NAC excision still remains the standard treatment. PATIENTS AND METHODS: From March 2002 to September 2003, 106 nipple sparing mastectomies (NSM) were peformed in 102 patients, 63% of whom had invasive carcinoma and 37% of whom had in situ carcinoma. Four patients underwent bilateral surgery. In all cases, a large or multicentric tumour and/or diffuse microcalcifications, clinically distant from the NAC, were present. During surgery, the tissue under the areola was routinely sampled to exclude the presence of tumor. If disease-free at the frozen sections, the NAC was spared and a NSM was performed. Additionally, a total dose of 16 Gy of radiotherapy (ELIOT) was delivered intraoperatively in the region of the NAC. All the patients underwent an immediate plastic breast reconstruction. RESULTS: In eleven patients (10.4%), the breast tissue under the areola resulted infiltrated at the definitive histological examination: in 10 cases a single or multiple foci of in situ carcinoma and in one case an invasive component were present. Eleven patients (10.4%) developed a superficial skin areolar slough followed by spontaneous healing, and 5 patients (4.7%) lost their NAC due to total necrosis. Among these, one patient had a poor cosmetic result on the NAC with asymmetrical location and required further surgical removal and reconstruction with tattoo and local flap in a better position. When rating the results from 0 (bad) to 10 (excellent), on average, the colour of the areola was rated 9/10, the sensitivity of nipple 3/10, the overall aesthetic result was rated 8/10 by both the surgeon and the patients. Early radiodystrophy (pigmentation) was observed in eight cases (7.5%). After an average follow up of 13 months, one local recurrence, located under the clavicula, far from the NAC, was observed. The preliminary results of the psychological study show a very high satisfaction with the preservation of the nipple (97.6 %), with younger women expressing a higher satisfaction than older counterparts. CONCLUSIONS: In selected cases, NSM with ELIOT of NAC has so far permitted good local control of the disease and satisfactory cosmetic results. Wider surgical experience is required to minimise the risk of leaving tumor cells in the region of the spared NAC and a longer follow up is necessary to evaluate the long term tumor recurrence rate at the NAC.

Perception that oral anticancer treatments are less efficacious: development of a questionnaire to assess the possible prejudices of patients with cancer.

We developed and pilot tested a 12-item questionnaire, to approach the issue of patients' perception on efficacy of oral chemotherapy. An additional question was on 'trade-off' between treatment efficacy and the ease of oral administration. The motivating underlying hypothesis was that oral drugs might be perceived by patients as less effective than when drugs were delivered by injection. The questionnaire was given to 59 patients with advanced breast cancer who received oral chemotherapy. Ninety-percent of patients considered clear and completed the questionnaire. Oral chemotherapy was positively viewed by most patients, perceiving it as advantageous (58%), able to help them feel less ill (77%) and to reduce the effort in coping with the disease (67%). The most important feeling elicited was the sense of freedom. Younger patients (<45 years) required bigger effort to face their illness and expected the most from oral chemotherapy. The questionnaire was shown to be robust, reliable and reproducible instrument in assessing patients' prejudices towards oral anticancer treatments.

The nipple-sparing mastectomy: early results of a feasibility study of a new application of perioperative radiotherapy (ELIOT) in the treatment of breast cancer when mastectomy is indicated.

BACKGROUND: Breast cancer surgery has become less and less mutilating, however a mastectomy is required in the case of multicentric, large tumors or recurrences after conservative treatment. The removal of the nipple areola complex during the mastectomy dramatically increases the feeling of mutilation. To reduce this negative psychological impact, in cancers located outside of the central area of the breast, we propose a new type of nipple-sparing mastectomy associated with intraoperative electron beam radiotherapy (ELIOT) delivered on the region of the areola. The nipple-sparing mastectomy is performed leaving 5 mm of glandular tissue behind the nipple areola complex to preserve its blood supply. The reconstruction is immediately performed with a prosthesis or an autologous flap. PATIENTS AND METHODS: Twenty-five patients were included in the study; two of them had a bilateral nipple-sparing mastectomy. RESULTS: Pathological examinations demonstrated the presence of 19 infiltrating carcinomas and 8 ductal carcinoma in situ. Two patients had a superficial skin areolar slough followed by spontaneous healing. One necrosis of the areola occurred due to extensive retroareolar dissection. In the early follow-up, the color of the areola was preserved. All patients except one expressed their satisfaction of having kept their areola. CONCLUSIONS: These preliminary results are encouraging but they require further studies to evaluate the long-term results, the local recurrence rate and the psychological impact.