A Novel Digital Patient-Reported Outcome Platform (Noona) for Clinical Use in Patients With Cancer: Pilot Study Assessing Suitability

Background As the incidence of cancer is on the rise, there is a need to develop modern communication tools between patients and the medical personnel. Electronic patient-reported outcome (ePRO) measures increase the safety of cancer treatments and may have an impact on treatment outcome as well. ePRO may also provide a cost-efficient way to organize follow-up for patients with cancer. Noona is an internet-based system for patients to self-report symptoms and adverse events of cancer treatments from home via a computer or a smart device (eg, smartphone, tablet). Objective In this pilot study, we assessed the suitability of a novel ePRO application (Noona) for patients with cancer, nurses, and doctors at the Helsinki University Hospital, Finland. Methods The study included 44 patients with cancer (different solid tumor types) and 17 health care professionals (nurses or medical doctors). Patients were either operated or received systemic treatment or radiotherapy. Patients reported their symptoms to the medical staff via Noona. In addition, patients and clinicians answered a questionnaire, based on which Noona’s suitability for clinical use was evaluated in terms of usability (ease of use, operability, and learnability), reliability (subjective opinion of the participant), and incidence of harmful events reported by the participants. Results A total of 41/44 (93%) patients and 15/17 (88%) professionals reported that the program was easy or quite easy to use; 38/44 (86%) patients and 11/17 (65%) professionals found Noona reliable, and 38/44 (86%) patients and 10/17 (59%) professionals would recommend Noona to other patients or their colleagues. No harmful incidences caused by the use of Noona were reported by the patients; however, 1 harmful incidence was reported by one of the professionals. Conclusions The majority of the participants felt that Noona appeared reliable and it was easy to use. Noona seems to be a useful tool for monitoring patient’s symptoms during cancer therapy. Future studies will determine the impact of this ePRO platform in routine clinical practice.


Introduction
According to the Finnish Cancer Registry, approximately 30,000 people receive cancer diagnoses in Finland every year, and the number of patients with cancer continues to rise.
Cancer treatments cause adverse events and long-term consequences. Patients receiving radiotherapy may experience irritation, redness of skin, pain, and fatigue. If the acute reactions remain improperly treated, patients may discontinue radiotherapy, leading to a loss of local control [1].
During chemotherapy patients commonly experience side effects such as nausea, fatigue, neutropenic infections, mucositis, peripheral neuropathy, and pain. These side effects impair patients' quality of life and may require emergency room visits, hospital stays, reductions in the following chemotherapy doses, or lead to treatment interruption [2]. Recognizing adverse events of chemotherapy early remains important to ensure proper medical interventions [3].
Digital communication between patients and cancer clinics via electronic patient-reported outcomes (ePROs) enables early detection of adverse events during chemotherapy, decreases emergency room visits and hospitalization, increases quality of life, and may even improve survival [3]. In the study by Denis et al [4], after primary treatment of lung cancer, disease relapse was detected earlier and the patients lived longer if they reported their symptoms via electronic software, compared with traditional follow-up visits. The overall survival was 19 months (95% CI 12.5 to noncalculable) in the study arm, compared with 12 months (95% CI 8.6-16.4, P=.001) in the control arm [4]. Because of these advantages, ePROs will likely be implemented in routine cancer care in the near future [5].
The aim of this study is to describe the usability of the first version of Noona, a web-mediated PRO application.

Methods
The investigated ePRO tool Noona is a web-mediated application developed by Noona Healthcare Oy in collaboration with Helsinki University Hospital Comprehensive Cancer Center. The Noona mobile service is developed for remote monitoring of patients with cancer, and to be used as a support tool for communication between patients with cancer and health care professionals. Noona is an online application, which can be used with a web browser and a suitable device, such as desktop, laptop, tablet, and smartphone. Noona has 2 clear user groups: patients with cancer and cancer care professionals, specifically nurses and doctors working in cancer hospitals. At the beginning of their treatment, patients with cancer are registered to Noona, and they will continue to use Noona during the follow-up and rehabilitation periods. During the treatment phase, Noona is designed to evaluate symptoms and recovery progress based on patient-reported outcome data. During the follow-up and rehabilitation periods, the intended use is to enable fluent and accessible communication between the patient and the professionals, and to monitor patient recovery from cancer and related symptoms.
Noona has 2 user interfaces: one for the patients ( Figure 1) and the other for the professionals (Figure 2). The main functionalities of the patient interface are symptom reporting and a diary. Patients can report on cancer-and treatment-related symptoms using question wizards that cover the clinically relevant questions and evaluate the most common and relevant symptoms, such as pain, fatigue, nausea, vomiting, and bowel symptoms. In addition to the symptoms, patients may contact their clinic regarding other topics using an open question form. Patients can also receive messages from their care team via Noona.  The main functionalities for the professionals are (1) a work queue to monitor new patients who have asked assistance or responded to a scheduled questionnaire, (2) a view of patient information as well as symptom history, and (3) a possibility to send messages directly to patients. When a patient starts to use Noona, the application provides a tutorial for the patient. As part of its implementation in the hospital, nurses are trained to give patients end user support. In the first version of Noona no alarm or reminder function was included and professionals were asked to check Noona regularly as part of their clinical work.
As part of the clinical evaluation of Noona, a prospective pilot trial was designed to study its usability and reliability by recruiting both patients with cancer and medical personnel, as both groups are expected to use the software during cancer treatments (ie, chemotherapy and radiotherapy or after cancer surgery). This clinical evaluation was part of the mandatory process before introducing Noona as a medical device to the markets in Finland and countries in Europe.
Patients were eligible if they were at least 18 years old; could read Finnish; received either radiotherapy, surgery, or medical therapy as a treatment for their cancer; and had a computer, phone, or tablet with an internet access available to be able to use Noona. Patients were asked to participate in the study by their physician during their routine visit at the hospital; otherwise their treatment continued according to local guidelines.
Participants spontaneously reported via the ePRO system that Noona "was easy to use" and "system was safe." Some participants (13 patients and 12 professionals) gave suggestions for improvements. Recommendations included adding an alarm function when a new message has arrived, adding capability for users to send pictures through the program, possibility for logging in automatically with a saved password, and having more options for the questions.

Principal Findings
This pilot study suggests that an ePRO application called Noona is feasible and acceptable in clinical practice. Most patients and professionals found Noona easy to log in and easy or quite easy to use. None of the patients reported difficulty with using Noona. Most of both patients and professionals would recommend Noona to other patients or colleagues.
None of the patients and only 1 professional reported a harmful event related to the use of Noona. In that case, the patient (female) did not understand that her symptoms were related to the treatment of cancer and thus did not report them via Noona; however, as per the professional, a direct face-to-face contact would have probably clarified the nature of her symptoms. None of the participants declined to participate in the study and only 2 participants were excluded from the study as they did not fill in the questionnaire. The high compliance rate suggests that participants found Noona easy enough to use. Only 2 patients had initial technical problems logging in, but these were subsequently resolved. One explanation for these promising results is that Noona has been designed in collaboration with the Helsinki University Hospital Comprehensive Cancer Center and the needs and requirements of both patients and professionals were recognized while developing Noona. A possible limitation of the study is that most participants had good digital literacy, which can limit the expansion of the results to different countries and populations.
As much as 8/10 (80%) of the nurses used Noona daily while none of the doctors did. This finding also reflects the current clinical practice, where most of the communication happens between patients and nurses.
Our results are in line with previous studies utilizing electronic data-collection tools [1,[6][7][8][9][10][11], but currently no data comparing Noona with the other tools in a randomized setting are available. In their study of patients with breast cancer, Abernethy et al [6] demonstrated a high level of patient compliance and satisfaction using a tablet-based data-collection system. According to the study authors, the ePRO helped patients to identify symptoms that deserve reporting to their cancer care provider.
Advances in information technology have enabled the utilization of many ePRO systems in cancer clinics [12]. ePRO collection provides a unique opportunity to monitor symptoms in real-time and provide clinical management during cancer care [9]. Incorporation of the ePRO tool in clinical practice thus generates the opportunity to collect patient data via a comprehensive system [6]. Some studies have shown that ePROs have a positive impact on patients' satisfaction [4,13], whereas others have found that ePROs are both feasible and acceptable [5,[14][15][16] in clinical practice because published data show that their use may improve patient's quality of life and even prognosis [4]. Because of these advantages, there is a growing interest in the use of internet-based follow-up systems.

Conclusion
Noona seems to be an easy-to-use and suitable tool to monitor patient-reported outcomes during cancer treatments. However, larger studies are needed to compare ePROs with traditional methods of contact with regard to patient preference, quality of life, resource utility, and costs.