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A prior commentary in this journal suggested that data-sharing from control cohorts in pharma-sponsored clinical trials could be a robust source of information to retrieve clinician-reported toxicities of systemic treatment [1]. A second one hypothesized that in depth information from exceptional responders without symptoms is as valuable as from the toxicity-laden patients [2]. We now advocate a broadly accessible, common infrastructure for patient-reported toxicities from all patients—in the so-called real-world—to facilitate enhanced collection of clinically meaningful and actionable data.
Advances in prevention and management of old and new toxicities begin with patient data to identify the nature, severity, and frequency of potential toxicities. Currently, most of our thinking about cancer regimen-related toxicities is based on clinician-reported data in clinical trials. Consequently, there are numerous examples of inconsistencies in the assessment of symptom frequency, severity, or consequences. The gap between provider-based toxicity assessment and what is actually experienced by patients is well known [3]. Importantly, we believe that more continuous patient-reported feedback is more valuable for documenting and understanding patient experiences in the community and at home compared to a cross-sectional inquiry in the consultation room.
We also believe that collecting “real-world” data from patients not participating in clinical trials provides an additional opportunity to chronicle and understand symptom data, because we then will include more extreme outcomes, i.e., toxicity-laden and also toxicity-free patients. In this way, we may begin to address the “whom?” and “why this person?” questions. In addition, it is essential that patients are followed from diagnosis (or at least before the start of treatment) until follow-up. Firstly, to assure that acquired treatment-associated symptoms can be differentiated from those symptoms which may already afflict treatment-naïve patients, and secondly, because we might use toxicity data collected during treatment to predict, and therefore act in the prevention of long-term complaints.
How can we achieve such a broad objective?
Monitoring patients and collecting patient-reported symptoms can be accomplished through the many emerging online applications [4]. The ultimate goal is blunting symptom progression through early intervention with the expectation of favorably impacting the health-related quality of life (HRQOL) by providing actionable outcomes [5]. The latter is particularly important, as information in the absence of it impacting a clinical response is merely an academic exercise.
Possibly most demanding would be the development of an internationally acceptable, affordable, and standardized data collection platform that integrates with existing electronic infrastructures. While challenging, there are examples of concept feasibility. The Dutch Patient Reported Outcomes Following Initial treatment and Long-term Evaluation of Survivorship (PROFILES) registry is a successful established infrastructure to collect patient-reported outcomes, including a web-based application to collect symptoms [6]. PROFILES contains over 60 patient-reported outcome measures (PROMs), has run online for 11 years in The Netherlands, and is also used in the UK. In recent years, data collection also includes activity trackers, online food diaries, online cognitive test batteries, and weighing scales with a bioelectrical impedance analysis system. Until now, over 30,000 cancer patients have been included in longitudinal data collection in over 100 Dutch health institutes. For the symptom-monitoring application, patients are asked to fill it out at least once a week in the phase of active treatment and thereafter each half a year. Subsequently, the patient as well as the health care provider receives an overview of symptoms over time [7]. In addition, patients receive an alert in case of severe or increasing symptoms, but only if it is plausible that (early) intervention can yield health benefits.
In our opinion, MASCC should take lead in such a broadly accessible, common registry collecting symptoms and other PROs to run research projects. It would generate a wealth of data for accelerating developments in prevention and management of toxicities of cancer care. Given the international nature of MASCC, an additional value is that such an infrastructure is inclusive; It minimizes the digital divide and gives healthcare providers and patients around the world the opportunity to benefit from the technological developments of symptom monitoring for individual care. For an association like MASCC, the small investments could return data of real potential value to industry stakeholders, which introduces a source for funding of future collaborative projects. Such a registry should be implemented through the MASCC Study Groups, as they cover all domains of supportive care in cancer. It will lead to a multitude of scientific publications on behalf of the study groups, which are keys for growth and impact of MASCC and its study groups.
Practically, we propose a restricted access, online MASCC environment to be build, so MASCC can coordinate access itself and reuse the content and data. Each research project should have a separated project section within the environment, so the project leads can monitor and manage the data collection themselves. It as well enables the lead to specify the type and timing of PRO-questionnaires for the particular project. In the project section, the leads can add participating hospitals and corresponding health care providers, who in turn provide access to their patients by automatically generating accounts. Subsequently, patients provide informed consent to use the data for scientific research at first log in and fill out questionnaires at the set time points. Security of data traffic and privacy regulations are of course of outmost importance, so hosting can only be done by a certified enterprise. Besides, collaborative international projects need consortium agreements about, e.g., data ownership. In the OncoDermatology Study Group, such a project environment, including agreements, has already been created in PROFILES for evaluation of chemotherapy-induced alopecia and scalp cooling, and can serve as a user case.
In conclusion, MASCC should facilitate its study groups with an online research tool. This secure, common infrastructure to capture patient-reported symptoms in the real-world would greatly contribute to knowledge about symptoms and accelerate developments and interventions for symptom management. It is an (cost-)efficient way to study the old and new toxicities as oncological care advances. Such a one-size infrastructure run by MASCC members can form the nidus of addressing needs of the MASCC Study Groups and therefore serve patients everywhere.
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Dr. van den Hurk received institutional implementation and research grants from AstraZeneca, Boehringer-Ingelheim, Bristol Myers Squibb, Ipsen, and Merck.
Dr. Sonis is an employee of Biomodels, LLC, and Primary Endpoint Solutions, LLC. Both companies assist industry, government, and academics to study and enable drugs, biologicals, and devices to treat patients for a broad range of indications including toxicities of cancer therapy. Dr. Sonis does not have equity or receive payment from any clients. Dr. Sonis is an Associate Editor for Supportive Care in Cancer.
Dr. Epstein serves on an advisory role for Galera Therapeutics, Tosk Pharma, and Rakuten Medical. Dr. Epstein is an Associate Editor-in-Chief for Supportive Care in Cancer.
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van den Hurk, C.J.G., Sonis, S.T. & Epstein, J.B. A common infrastructure for real-world patient-reported symptoms: one size fits many. Support Care Cancer 30, 7833–7834 (2022). https://doi.org/10.1007/s00520-022-07295-w
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DOI: https://doi.org/10.1007/s00520-022-07295-w