Trial reportJCO oncology practice2021
Electronic Patient Reporting of Adverse Events and Quality of Life: A Prospective Feasibility Study in General Oncology.
Trial report in JCO oncology practice, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
24 citing papers in PubMed, 25 citations in OpenAlex.
- Trial
- Adverse events self-reported by patients with extensive-stage small-cell lung cancer in the phase III CASPIAN study.Future oncology (London, England) · 2025Trial
- Remote Patient-Reported Outcomes and Activity Monitoring to Improve Patient-Clinician Communication Regarding Symptoms and Functional Status: A Randomized Controlled Trial.JCO oncology practice · 2023Trial
- Development and Validation of a Predictive Model of Severe Fatigue After Breast Cancer Diagnosis: Toward a Personalized Framework in Survivorship Care.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2022Trial
- Effectiveness of electronic patient-reported outcomes in patients with cancer undergoing immunotherapy: a real-world retrospective study.International journal of clinical oncology · 2026Article
- Electronic patient-reported outcome monitoring system for sarcoma patients undergoing drug treatment: a development and feasibility study.BMC cancer · 2026Article
- Heavy Metal Toxicity in Clinical and Environmental Health: Sources, Mechanisms, Diagnostics, and Evidence-Based Management of Mercury, Lead, Cadmium, and Arsenic.International journal of molecular sciences · 2026Review
- Electronic patient-reported adverse event monitoring in academic early-phase clinical trials: A feasibility study.Clinical trials (London, England) · 2026Article
- Article
- Scoping review of oncology clinical trials nursing: Roles, competencies, and evolving practice in cancer research.Canadian oncology nursing journal = Revue canadienne de nursing oncologique · 2026Article
- Under the radar-frequency, timing, duration, and trajectory of lower-grade adverse events in clinical trials of anti-cancer therapies.The oncologist · 2025Article
- A Text Message Intervention to Minimize the Time Burden of Cancer Care.NEJM catalyst innovations in care delivery · 2025Article
- Glioblastoma Patient and Caregiver Perspectives of Treatment Side-Effects and Information Provision.Journal of patient experience · 2025Article
- Patients' daily reporting of symptoms via mobile application reveals a significant difference between patients' perceptions and doctors' interpretations.Frontiers in oncology · 2025Article
- Active symptom monitoring for premenopausal women with breast cancer initiating adjuvant endocrine therapy: Protocol for the SWOG S2010 randomized controlled efficacy trial.Contemporary clinical trials · 2024Article
- Unleashing patient voices: empowering adverse event assessment with complete patient-reported outcomes.The oncologist · 2024Article
- Digital Health Applications in Oncology: An Opportunity to Seize.Journal of the National Cancer Institute · 2022Article
- Article
- Developing a Mobile Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events Administration System to Capture Postradiation Toxicity in Oncology: Usability and Feasibility Study.JMIR formative research · 2022Article
- Safety culture and adverse event reporting in Ghanaian healthcare facilities: Implications for patient safety.PloS one · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 3 institutions in 1 country.
Funding
Abstract
purposeAdverse event (AE) reporting is essential in clinical trials. Clinician interpretation can result in under-reporting; therefore, the value of patient self-reporting has been recognized. The National Cancer Institute has developed a Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) for direct patient AE reporting. A nonrandomized prospective cohort feasibility study aimed to explore the compliance and acceptability of an electronic (Internet or telephone) system for collecting patient self-reported AEs and quality of life (QOL).
methodsOncology patients undergoing treatment (chemotherapy, targeted agents, hormone therapy, radiotherapy, and/or surgery) at 2 hospitals were sent automated weekly reminders to complete PRO-CTCAE once a week and QOL (for a maximum of 12 weeks). Patients had to speak/understand English and have access to the Internet or a touch-tone telephone. Primary outcome was compliance (proportion of expected questionnaires), and recruitment rate, attrition, and patient/staff feedback were also explored.
resultsOf 520 patients, 249 consented (47.9%)-mean age was 62 years, 51% were male, and 70% were married-and 230 remained on the study at week 12. PRO-CTCAE was completed at 2,301 (74.9%) of 3,074 timepoints and QOL at 749 (79.1%) of 947 timepoints. Individual weekly/once every 4 weeks compliance reduced over time but was more than 60% throughout. Of 230 patients, 106 (46.1%) completed 13 or more PRO-CTCAE, and 136 (59.1%) of 230 patients completed 4 QOL questionnaires. Most were completed on the Internet (82.3%; mean age, 60.8 years), which was quicker, but older patients preferred the telephone option (mean age, 70.0 years). Positive feedback was received from patients and staff.
conclusionSelf-reporting of AEs and QOL using an electronic home-based system is feasible and acceptable. Implementation of this approach in cancer clinical trials may improve the precision and accuracy of AE reporting.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.