A multicenter randomized trial for quality of life evaluation by non-invasive intelligent tools during post-curative treatment follow-up for head and neck cancer: Clinical study protocol.

Patients surviving head and neck cancer (HNC) suffer from high physical, psychological, and socioeconomic burdens. Achieving cancer-free survival with an optimal quality of life (QoL) is the primary goal for HNC patient management. So, maintaining lifelong surveillance is critical. An ambitious goal would be to carry this out through the advanced analysis of environmental, emotional, and behavioral data unobtrusively collected from mobile devices. The aim of this clinical trial is to reduce, with non-invasive tools (i.e., patients' mobile devices), the proportion of HNC survivors (i.e., having completed their curative treatment from 3 months to 10 years) experiencing a clinically relevant reduction in QoL during follow-up. The Big Data for Quality of Life (BD4QoL) study is an international, multicenter, randomized (2:1), open-label trial. The primary endpoint is a clinically relevant global health-related EORTC QLQ-C30 QoL deterioration (decrease ≥10 points) at any point during 24 months post-treatment follow-up. The target sample size is 420 patients. Patients will be randomized to be followed up using the BD4QoL platform or per standard clinical practice. The BD4QoL platform includes a set of services to allow patients monitoring and empowerment through two main tools: a mobile application installed on participants' smartphones, that includes a chatbot for e-coaching, and the Point of Care dashboard, to let the investigators manage patients data. In both arms, participants will be asked to complete QoL questionnaires at study entry and once every 6 months, and will undergo post-treatment follow up as per clinical practice. Patients randomized to the intervention arm (n=280) will receive access to the BD4QoL platform, those in the control arm (n=140) will not. Eligibility criteria include completing curative treatments for non-metastatic HNC and the use of an Android-based smartphone. Patients undergoing active treatments or with synchronous cancers are excluded. Clinical Trial Registration: ClinicalTrials.gov, identifier (NCT05315570).

Genetic Testing Consumers in Italy: A Preliminary Investigation of the Socio-Demographic Profile, Health-Related Habits, and Decision Purposes.

Aim of the study: Genetic testing is becoming increasingly common in clinical practice and health management; nonetheless, little is known about how the population approaches genetic services through private companies. Our study aims to describe socio-demographic aspects, health-related habits, and overall beliefs and knowledge about genetic risk and testing in a population of Italian citizens who decided to undergo a genetic examination through a private genetic company. Study design: A sample of 152 clients from an Italian private genetic company completed an ad-hoc survey from September 2016 to February 2018, addressing socio-demographic data, health habits, psycho-physic condition, perceived utility of genetic results, decision purposes about data sharing, and behavioral changes after results. Results: Participants (mean age 42.4) were predominantly female (82.2%) and were overall well-educated. Their main source of information were physicians (77%), and 41.1% entrusted the management of results to the same. Thirty-eight percentage underwent genetic analysis for cancer predisposition, 31.3% for fertility problems, 24% for dietary or intolerance issues in the period of enrolment. More than half of them (62.7%) reported a family history of the disease, and overall 69% had a current or past experience with a disease. Clients perceived the genetic screening as useful to adopt behaviors that may prevent disease onset (37.7%), to know their "real health status" (27.4%), and to adopt health-related behaviors (23.3%). 62.8% claimed they were motivated to change behaviors after results (healthier diet, practice exercise, medical checks), and they wanted to share results with their physician and family members. Discussion/Conclusion: The overview of consumers' profiles in Italy and other European countries can contribute to tailoring and regulating genetic services in a way that could be efficient in terms of healthy choices, behaviors, and health resource expenditures for the general public.

Patients' experience with MRI-guided in-bore biopsy versus TRUS-guided biopsy in prostate cancer: a pilot study.

BACKGROUND: Ultrasound-guided magnetic resonance imaging (MRI)-fusion biopsy and in-bore MRI-guided biopsy (MRGB) have improved the diagnostic pathway in patients with suspected prostate cancer compared to the traditional random sampling of the prostate gland under transrectal ultrasound guidance (TRUS-Bx). The aim of our study was to assess the psychological experiences of patients undergoing MRGB and TRUS-Bx. METHOD: Participants completed an ad hoc set of 11 items to be rated from 0 (not at all) to 10 (very much) on visual analogue scales and one open question on the most worrisome aspect of the procedure. The set of items evaluated satisfaction with the information received and the possibility to ask questions to the staff; the tolerability of the irritation, duration and discomfort associated with the exam; their level of worry or calm before the exam; the perceived need to undergo the exam; their satisfaction with the exam and willingness to repeat it in the future; and acceptability of the exam. RESULTS: Between May 2018 and June 2019, 47 participants were enrolled on the day of their MRGB; 24 had previously undergone TRUS-Bx. The MRGB was rated with high positive scores on all 11 items. The lowest ratings regarded the duration of the exam (mean = 6.6) and feeling calm (mean = 6.6). Participants were significantly more satisfied with MRGB than TRUS-Bx, rating it as less painful and more comfortable, necessary and tolerable. CONCLUSION: These preliminary results indicate that the MRGB is likely to be more tolerable and acceptable to patients than TRUS-Bx.

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.

The patient perspective: investigating patient empowerment enablers and barriers within the oncological care process.

Patient empowerment is a multi-factorial concept and its relevance has led to a growing body of literature; despite this attention, there is still no agreement regarding the elements that define its expression. While several studies have already investigated the positive effect of empowerment interventions on the care process outcome, the aim of this study is to investigate which factors can foster an empowered management of the cancer condition from the patient's perspective. To examine patients' perception of empowerment enablers, we asked for participants' input on the role of three factors frequently cited as positively affected by empowerment: care quality, perception of direct control and relationships within the care context, during the care process. Three focus groups were conducted with 34 cancer patients. The results highlight the perception of direct control on their treatment as the least valued element (2.87, SD 0.566) when compared with care quality (3.75, SD 0.649) and relational support in the care context (3.91, SD 0.274). Unlike traditional approaches to empowerment, patient's expression of empowerment does not mainly reside in the direct control of their condition as much as in an active role within the relationship with caretakers, such as the ability to choose the doctor, the care team or the health organisation in charge of their healthcare. Emerging aspects from this analysis of patient's perspective are central in order to adequately consider empowerment in the care process and to provide more effective care strategies.

Training Cognitive Functions Using Mobile Apps in Breast Cancer Patients: Systematic Review.

BACKGROUND: Breast cancer is an invalidating disease and its treatment can bring serious side effects that have a physical and psychological impact. Specifically, cancer treatment generally has a strong impact on cognitive function. In recent years, new technologies and eHealth have had a growing influence on health care and innovative mobile apps can be useful tools to deliver cognitive exercise in the patient's home. OBJECTIVE: This systematic review gives an overview of the state-of-the-art mobile apps aimed at training cognitive functions to better understand whether these apps could be useful tools to counteract cognitive impairment in breast cancer patients. METHODS: We searched in a systematic way all the full-text articles from the PubMed and Embase databases. RESULTS: We found eleven studies using mobile apps to deliver cognitive training. They included a total of 819 participants. App and study characteristics are presented and discussed, including cognitive domains trained (attention, problem solving, memory, cognitive control, executive function, visuospatial function, and language). None of the apps were specifically developed for breast cancer patients. They were generally developed for a specific clinical population. Only 2 apps deal with more than 1 cognitive domain, and only 3 studies focus on the efficacy of the app training intervention. CONCLUSIONS: These results highlight the lack of empirical evidence on the efficacy of currently available apps to train cognitive function. Cognitive domains are not well defined across studies. It is noteworthy that no apps are specifically developed for cancer patients, and their applicability to breast cancer should not be taken for granted. Future studies should test the feasibility, usability, and effectiveness of available cognitive training apps in women with breast cancer. Due to the complexity and multidimensionality of cognitive difficulties in this cancer population, it may be useful to design, develop, and implement an ad hoc app targeting cognitive impairment in breast cancer patients.