Mental health-related impact applying a scalp cooling technology solution in chemotherapy: a scoping review


 Background and ObjectiveA scalp cooling system, particularly, a digitised scalp-cooling system, is currently assuming an important role during adjuvant treatment within the oncological setting, promising the prevention of hair loss and turning an efficient procedure to reinforce the mental health of patients during chemotherapy by preventing chemotherapy-induced alopecia (CIA). We conducted a scoping review to map the literature on the efficacy of the scalp cooling technology in chemotherapy. We focused on the efficacy of the scalp cooling system in preventing CIA and the associated mental health effects, such as reducing mood changes, depression, anxiety, anger, sleep disorders, and fatigue.MethodsWe performed a systematic search of MEDLINE via PubMed, Embase, Web of Science, PsycINFO, and Scopus in May 2020. We conducted a descriptive analysis of the characteristics of the included literature. Based on the exclusion/inclusion criteria, a total of 17 articles were included in the scoping review process.ResultsThis review demonstrated the lack of research on the efficacy of adopting the scalp cooling system as preventive care for the well-being of patients through the prevention of their hair loss. Nevertheless, research on this topic is progressively increasing, and future studies should address specific key points.ConclusionThis study aimed to identify emerging and urgent research domains in order to design better clinical outcomes for innovative solutions, integrating the physical and mental health of oncological patients in survivorship.


Introduction
Cancer patients face a number of disease-related challenges that lead to clinically relevant mood disorders, psychological distress, and depression (Linden et al., 2012;Seiler & Jenewein, 2019;Di Giacomo et al., 2019). In primary treatment, patients have to deal with chemotherapy and its associated burdensome physical effects, as well as effects on body image (Mehnert et al., 2018). One such side-effect is chemotherapy-induced alopecia, a temporary form of hair loss that could in uence the mental health of patients who suffer from it. In order to support patients dealing with the side effects of adjuvant treatments, the scalp hypothermia technique was introduced as a preventative measure against the development of CIA. Technological innovations in clinical medicine, speci cally in oncological treatments, allowed for the introduction of a scalp cooling system aimed at preventing hair loss during chemotherapy treatment. Currently, DigniCap, a digitized scalp-cooling system, is assuming an important role in the clinical setting during adjuvant treatment, promising hair loss prevention and allowing an e cient procedure to reinforce the mental health of patients during chemotherapy by avoiding CIA. DigniCap comprise a refrigerator unit and a control unit integrated into a mobile cabinet and connected to a tight-tting cooling cap. This system maintains a constant scalp temperature of + 5°C during all chemotherapy treatments (lasting during the entire session, for minimum of 4 hours or longer, as part of the planned chemotherapy regimen). The application of this digital solution in medical treatments is primarily based on experimentation data demonstrating reduction in the rate of hair loss as the primary outcome for a higher quality of life during chemotherapy and post-primary treatment (Giarratano et al., 2019). The increasing application of scalp cooling systems in chemotherapy has led to the emergence of an innovative solution in clinical medicine related to mental health during oncological treatments.
The aim of this study is to map the literature regarding the mental health in uence of the DigniCap system's application in chemotherapy treatments, de ning the strengths and weaknesses of the research topic. This scoping review focuses on the e cacy of the DigniCap system in preventing CIA as well as its in uence on mental health, particularly, in reducing mood changes, depression, anxiety, anger, sleep disorders, and fatigue. Speci cally, we wanted to quantify and synthetize the studies conducted thus far regarding the e cacy of the mental health effect of the digitised scalp cooling systems and highlight the emerging key points for future research protocols. Ideally, our ndings could aid in the harmonisation of the implementation of cancer care toward high quality of life in survivorship. The scope of this review is to maximise the value of previously published ndings and to harmonise future study approaches, drawing on potential future challenges and prompting key components for future research.

Methods
We conducted a scoping review to map the literature on the e cacy of the DigniCap technology in chemotherapy. The framework outlined by Arksey and O'Malley (2005) in their methodological paper on scoping studies was adopted. Our aim was 1) to summarise and disseminate current available evidence for the impact of DigniCap on the psychological needs of oncological patients, and 2) to propose key points for future research.
Speci cally, the research objectives of this review have been: 1. to summarise the current evidence on the DigniCap's impact on the quality of life and wellness of patients; 2. to identify gaps in the literature that may require further research; and 3. to identify relevant research questions, particularly, the determinants of future implementation approaches.

Search strategy
We performed a systematic search of MEDLINE via PubMed, Embase, Web of Science, PsycINFO, and Scopus in May 2020 with the terms 'dignicap', 'scalp cooling', 'scalp hypothermia', and 'hypothermic cap', combined with 'quality of life', 'wellness', and 'clinical psychology', published from May 2000 to May 2020.

Inclusion and exclusion criteria
We included all literature related to the Dignicap system published in English until 30 May 2020 without restrictions. This comprised reviews, clinical studies, basic research, epidemiological studies, and clinical trials. However, we excluded news reports that were not published in scienti c journals and articles whose full text we were unable to access despite contacting the authors.

Article selection and data extraction
Two reviewers independently screened all titles, abstracts, and full texts and resolved disagreements by consensus or consultation with a third reviewer. The following information were extracted: (i) title, (ii) authors, (iii) journal, (iv) publication or posted date, (v) type of article/study, (vi) topic, (viii) objectives of study, and (ix) results.

Statistical analysis
We conducted a descriptive analysis of the characteristics of the included literature. We described the source, publication date, type of article/study, and topic of article/study to examine the existing gaps in research. We categorised the literature into reviews, clinical studies (including randomised controlled trials and observational studies), basic research, epidemiological studies, editorial comments, and other categories if identi ed. We conducted this scoping review in accordance with the PRISMA-ScR Checklist (Tricco et al., 2018).

Search results
Our initial search returned n 35 papers from our database. After duplicate and inadequate articles were removed, we identi ed n 20 records that underwent title and abstract review for relevance. Then, three articles were excluded during full-text review.. The articles included in the scoping review were cohort studies, review studies, clinical trials, and basic research.
The platform of publication is generally on oncological outlook (Current Oncology, Cancer Research, and Breast Cancer Research & Treatment), involving mostly Italian and American authors. Moreover, looking at the posted date of publication, interest in this topic is seen to be increasing progressively over time.  Table 1b reports the typologies of the studies conducted to date. The cohort study design seemed to be more widely applied than the other study designs. By contrast, there was a lower rate of published basic research and clinical trial study designs. Finally, the research topic that had been more relevant in the literature was the investigation of CIA prevention e cacy. Following this was the focus on the impact on psychological needs (quality of life and emotional traits).
In Table 2, screened articles highlighting the details of each research protocol were grouped into three study designs: clinical trials (n = 3), cohort studies (n = 8), and basic research (n = 4). Clinical trials Smetanay et al., 2018;Munzone et al., 2019) have been conducted mostly from a multicentric perspective and observational studies. In cohort study designs (Rugo et al., 2012;Fehr et al., 2016;Rugo et al., 2017;Vassalli et al., 2018;Chan et al., 2019;Giarratano et al., 2019;Prochilo et al., 2019;Orlando et al., 2019) prospective observational studies have been conducted mostly in multicentric research, focusing on CIA and quality of life, satisfaction, and patient-reported performance variables in an oncological population diagnosed with breast cancer. All studies reported a good rate of success for the DigniCap technology associated with chemotherapy treatment, particularly, regarding hair loss (average: 25% of CIA). The included studies reported an average of 30% drop-out rate from the scalp cooling application. Finally, an average of 10% of patients reported adverse events (headache) and/or were discontinued from the treatment due to feeling cold. Regarding the positive psychological impact of the DigniCap technology, preventing CIA and improving the quality of life was not signi cantly detected. Vassalli et al. (2018)  The basic research category (Friedrichs et al., 2014;Campos-Gomez et al., 2015;Peerbooms et al., 2015;Shaw et al., 2016) are composed of three observational studies and one qualitative study. Observational studies detected higher well-being in successfully scalp-cooled patients, as indicated by a generally better health-related quality of life associated with the conservative effect of the DigniCap technology for hair loss. A qualitative study offered a thematic analysis of the patient experience of scalp cooling: the promise of faster regrowth seemed a motivator for adherence to the DigniCap application.
In Table 3, review studies (n = 2) are reported. Breed's review (2011)  that there were either non-signi cant or no improvements, and 1 (7.7%) provided a mixed conclusion. Although 2 (50%) randomised controlled trials demonstrated that scalp cooling can effectively prevent CIA depending on the chemotherapy regimen, these studies did not show that successful hair preservation was associated with improved quality of life measures. The screened reviews showed increasing interest in the DigniCap technology over time, and implemented investigations to analyse the magnitude of impact on mental health of oncological patients during and after chemotherapy intervention.

Discussion And Conclusion
The aim of this scoping review was to map and determine the current literature regarding the mental health impact of DigniCap technology applied to chemotherapy treatment in terms of quality of life and wellness of oncological patients. Considering the exclusion/inclusion criteria, a total of 17 articles were included in the scoping review process.
The DigniCap technological solution was designed to reduce the distressing factor induced by CIA as a side-effect of exposure to chemotherapy in oncological patients. This innovative solution aimed to be a preventive intervention that could improve patient care.
This review has demonstrated the lack of research conducted on the e cacy of the DigniCap system adoption as preventive care for the well-being of patients through the prevention of their hair loss. Progressively, researchers have investigated the e cacy of the DigniCap technology for measuring physical preservation, taking into account the rate of hair loss and measuring the degree of satisfaction. Innovative solutions should be better studied by considering mental health-related effects during pharmacological treatment and post-treatment. Our results showed a lack of investigation focused on well-being and emotional impact indexes, as well as the patient-oriented perspective for quality of life. The implementation of research in this area, particularly, the progress in the number of research protocols on this topic, are increasing. Future research should address these key points: DigniCap-targeted aims for mental e cacy. The main objective of this study was to evaluate hair quantity (preserved or lost) as a measure of quality of life in terms of mental health and well-being. According to Marks et al. (2019), the correlation between successful hair preservation and improved quality of life has not yet been veri ed, even if studies focused on this topic apply different evaluation systems. Targeted aims should be addressed and tailored to develop DigniCap-speci c measurements for the quality of life of cancer patients. Moreover, the associated effect of DigniCap application should be expanded to the evaluation of the patient's mental health, and not just hair measurements. Over time follow-ups could be able to explain mental health e cacy and/or adverse effects.
Consent about what constitutes a successful rate during DigniCap use. The scoping review highlighted the lack of consent regarding what constitutes the scalp cooling success rate. Researchers have applied evaluation processes based on various tests and measures: hair preservation rate, fast regrowth rate, growth rate time, heterogeneous patient reports, and medical reports. However, future research should focus on mental health effects, paying attention to the personality, psychological traits, and social determinants of patients as in uencing factors for the successful impact of the technological solution (DigniCap) in chemotherapy. Qualitative and quantitative assessments would address compound wellness and quality of life endpoints.
Mental health outcomes of DigniCap use. The e cacy of the DigniCap system should be better tested. Preventive interventions for better adherence and successful effects of DigniCap treatment could be performed. Structured and accurate informative psychological mediation could be developed to mitigate the negative effects (mood issues) and boost the potential positive mental impact on quality of life and well-being during treatment, and even more after the treatment.
Clinical Implication. Guidelines and recommendations might be identi ed in order to reduce unexpected psychological distress, personal unmodulated expectations, drop-outs, and a lower sense of well-being. Lastly, aesthetic learning and self-caring should be tested as an adjuvant individual action to improve the psychological adaptation process of patients to the intensive clinical treatment, preventing mental distress during medical pathways.
Limitations. The limitation of this review is the low number of studies that met our inclusion criteria. This limit highlights the need to improve research interest in this topic, as well as on the direct and quick impact to the clinical practice of oncological treatments. A better tailored clinical pathway can enhance the exploitation of the potential of innovative technological solutions in chemotherapy.

Declarations Funding
This study did not receive funding from any source.