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Assessment of Patient Reported Outcomes (PROs) in Outpatients Taking Oral Anticancer Drugs Included in the Real-Life Oncoral Program.

ABSTRACT: Background In previous studies, patient-reported outcomes (PROs) have been shown to improve survival in cancer patients. The aim of the present study was to assess symptoms potentially related to adverse events experienced by cancer outpatients treated by oral anticancer agents (OAAs) using PROs. Methods Between September 2018 and May 2019, outpatients starting OAAs were included in a 12-week follow-up to assess 15 symptoms listed in the National Cancer Institute PRO Common Terminology Criteria for Adverse Events, using a 5-point scale of severity or frequency. Patients were requested to alert a referral nurse or pharmacist when they self-assessed high-level (level 3 or 4) symptoms. Results 407 questionnaires were completed by 63 patients in which 2333 symptoms were reported. Almost three-quarters (74.6%) reported at least one high-level symptom. The symptoms that were most commonly experienced were fatigue (>9 in 10 patients; 13.2% of symptoms declared), various psychological disorders (>9 in 10 patients; 28.6% of symptoms declared) and general pain (>8 in 10 patients; 9.4% of symptoms declared). Conclusion PROs are appropriate to detect potential adverse events in cancer outpatients treated by OAAs. This study is the first step for integrating the patient's perspective in a digital e-health device in routine oncology care.

SUBMITTER: Collomb B

PROVIDER: S-EPMC8833408 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature

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Assessment of Patient Reported Outcomes (PROs) in Outpatients Taking Oral Anticancer Drugs Included in the Real-Life Oncoral Program.

Collomb Bastien B Dubromel Amélie A Caffin Anne Gaëlle AG Herledan Chloé C Larbre Virginie V Baudouin Amandine A Cerutti Ariane A Couturier Laurence L Maire Magali M Karlin Lionel L Maucort-Boulch Delphine D Huot Laure L Dalle Stéphane S Bachy Emmanuel E Ghesquieres Hervé H Salles Gilles G Couraud Sébastien S You Benoit B Freyer Gilles G Trillet-Lenoir Véronique V Ranchon Florence F Rioufol Catherine C

Cancers 20220128 3

Background In previous studies, patient-reported outcomes (PROs) have been shown to improve survival in cancer patients. The aim of the present study was to assess symptoms potentially related to adverse events experienced by cancer outpatients treated by oral anticancer agents (OAAs) using PROs. Methods Between September 2018 and May 2019, outpatients starting OAAs were included in a 12-week follow-up to assess 15 symptoms listed in the National Cancer Institute PRO Common Terminology Criteria ...[more]

PMID: 35158928

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Project description:IntroductionThe development of oral anticancer agents (OAA) has profoundly changed cancer care, leading patients to manage their chemotherapy treatment on an outpatient basis. The prevention of iatrogenic effects of OAA remains a major concern, especially since their side effects are not less serious than those of intravenous chemotherapy. The ONCORAL programme was set up to secure the management of OAA in cancer patients followed at the Lyon University Hospital. This multidisciplinary programme involves hospital pharmacists, nurses, oncologists, and haematologists, as well as community health professionals. Given the economic stakes that this programme entails for the health system, a medico-economic study was designed.Methods and analysisThis is a prospective controlled study, with individual open-label randomisation. A total of 216 outpatients treated with OAA and at risk of developing a drug-related iatrogenic event, will be randomised (2:1) to undergo follow-up in the ONCORAL programme or usual care. The primary outcome will be the estimation of the incremental cost-effectiveness ratio (difference in total costs per quality adjusted life years gained) at 12 months between the two groups. The secondary outcomes will be evaluation of OAA management consequences (relative-dose intensity, adherence, adverse drug events, drug-drug interactions, and proven medication errors), evaluation of overall survival and cancer-related quality of life, and patient-reported outcomes in relation to the treatment. A budget impact analysis will be implemented. Patient and health professional satisfaction regarding the ONCORAL programme will be measured.Ethics and disseminationApproval to conduct this study was obtained from an Ethics Committee (Comité de Protection des Personnes Ile-de-France VI) in October 2019, and from the French data protection agency (Commission Nationale de l'Informatique et des Libertés), according to the French Law. Trial results will be disseminated at clinical conferences and published in peer-reviewed journals.Trial registrationNCT03660670.

Project description:BACKGROUND:Widespread adoption by patients is imperative for the success of app-based interventions for enhancing adherence to oral anticancer medications. Patients' attitudes and beliefs should be evaluated to understand determinants of their acceptance and adoption of such interventions. OBJECTIVE:To identify factors that influence cancer patients' intention to adopt an app-based system for enhancing oral anticancer medication adherence. METHODS:This study was conducted as part of the usability evaluation of an app-based system for enhancing adherence. We followed the grounded theory approach employing audio-recorded face-to-face interviews for data collection from patients taking oral anticancer medications (n = 15) and caregivers of such patients (n = 3). Data analysis involved verbatim transcription of all interviews, coding of the transcripts and field notes, detailed memo writing, and constant comparative evaluation of emergent categories. RESULTS:A conceptual framework of facilitating and hindering factors for users' adoption intention for an oral anticancer medication adherence app was developed. Findings suggest that facing difficulties in maintaining adherence and patients' perceived superiority of the app over their current methods facilitate adoption intention. In contrast, having to pay, lack of language options and users' perception of low competence in using an app were the hindrance factors. CONCLUSION:This study showed that adoption of adherence apps could be explained by technology acceptance constructs, such as performance expectancy. Adoption intention was also facilitated by patients perceived vulnerabilities in maintaining adherence to their medications, which was a health behaviour construct. Implementation of app-based programs should address patients' perceived vulnerabilities and relative advantage of the app over their current methods. Clinicians and app developers should also consider the financial, technological and language barriers for end users.

Project description:ImportanceMedications are associated with substantial environmental outcomes, yet frequently end up being unused by patients. Waste-minimizing interventions, such as redispensing of quality-approved oral anticancer drugs remaining unused by patients at home, could reduce the environmental footprint of cancer treatment.ObjectivesTo assess the environmental outcomes of redispensing quality-assured oral anticancer drugs and to explore how redispensing could be environmentally optimized.Design, setting, and participantsIn this quality improvement study, a cradle-to-grave life cycle assessment was performed in the outpatient pharmacy of 4 Dutch hospitals, based on a prospective multicenter trial comprising 1071 patients with a clinical diagnosis of cancer and an active prescription for an oral anticancer drug stored at room temperature from February 1, 2021, to February 1, 2023, with a follow-up of 12 months per patient.InterventionParticipants received prescribed oral anticancer drugs with additional quality-assurance materials (ie, seal bags and time-temperature indicators), so the pharmacy could redispense quality-assured drugs based on authenticity, appearance, remaining shelf life, and/or adequate storage.Main outcomes and measuresThe estimated environmental outcomes avoided due to waste reduction (ie, production and transport and incineration of redispensed oral anticancer drugs) corrected for outcomes of process burdens (ie, quality assurance materials), quantified in 3 outcome measures: human health damage (disability-adjusted life-years), ecosystems damage (species × year), and climate change (kg of carbon dioxide equivalent [CO2-eq]) per patient per year.ResultsA volunteer sample of 1071 patients (median age, 70 years [IQR, 62-75 years]; 622 men [58.1%]) participated in the intervention. Redispensing oral anticancer drugs was initially associated with an environmental burden, mainly because of the high impact of time-temperature indicators. However, when quality-assurance materials were selectively used for temperature-sensitive oral anticancer drugs (ie, maximum storage temperature of 25 °C), redispensing was environmentally beneficial to human health and ecosystems, providing estimated climate benefits of 1.9 kg (95% CI, 1.4-2.6 kg) of CO2-eq per patient per year.Conclusions and relevanceIn this quality improvement study, redispensing unused oral anticancer drugs was found to be a suitable strategy to reduce waste and improve environmental sustainability of cancer treatment after process optimization. Redispensing unused oral anticancer drugs could contribute to sustainability of cancer treatment through reduced costs and environmental outcomes.

Dataset Information

Assessment of Patient Reported Outcomes (PROs) in Outpatients Taking Oral Anticancer Drugs Included in the Real-Life Oncoral Program.

Publications

Assessment of Patient Reported Outcomes (PROs) in Outpatients Taking Oral Anticancer Drugs Included in the Real-Life Oncoral Program.

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