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Reporting time toxicity in prospective cancer clinical trials: A scoping review

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Abstract

Purpose

This review aimed to assess the measurement and reporting of time toxicity (i.e., time spent receiving care) within prospective oncologic studies.

Methods

On July 23, 2023, PubMed, Scopus, and Embase were queried for prospective or randomized controlled trials (RCT) from 1984 to 2023 that reported time toxicity as a primary or secondary outcome for oncologic treatments or interventions. Secondary analyses of RCTs were included if they reported time toxicity. The included studies were then evaluated for how they reported and defined time toxicity.

Results

The initial query identified 883 records, with 10 studies (3 RCTs, 2 prospective cohort studies, and 5 secondary analyses of RCTs) meeting the final inclusion criteria. Treatment interventions included surgery (n = 5), systemic therapies (n = 4), and specialized palliative care (n = 1). The metric “days alive and out of the hospital” was used by 80% (n = 4) of the surgical studies. Three of the surgical studies did not include time spent receiving ambulatory care within the calculation of time toxicity. “Time spent at home” was assessed by three studies (30%), each using different definitions. The five secondary analyses from RCTs used more comprehensive metrics that included time spent receiving both inpatient and ambulatory care.

Conclusions

Time toxicity is infrequently reported within oncologic clinical trials, with no standardized definition, metric, or methodology. Further research is needed to identify best practices in the measurement and reporting of time toxicity to develop strategies that can be implemented to reduce its burden on patients seeking cancer care.

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Data availability

No datasets were generated or analysed during the current study.

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Authors and Affiliations

  1. The Ohio State University Wexner Medical Center, Columbus, OH, USA

    Patrick L. Quinn, Connor Hannon, Angela Sarna, Brittany L. Waterman, Jordan M. Cloyd, Laura J. Rush & Ann Scheck McAlearney

  2. University College Dublin, Dublin, Ireland

    Shah Saiyed

  3. Southern Ohio Medical Center, Portsmouth, OH, USA

    Rodney Spriggs

  4. Division of Surgical Oncology, Department of Surgery, University of Illinois Chicago, Chicago, IL, USA

    Aslam Ejaz

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Contributions

All authors contributed to the study’s conception and design. Material preparation, data collection, and analysis were performed by P.L.Q. and S.S. The first draft of the manuscript was written by P.L.Q. and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

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Correspondence to Aslam Ejaz.

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Quinn, P.L., Saiyed, S., Hannon, C. et al. Reporting time toxicity in prospective cancer clinical trials: A scoping review. Support Care Cancer 32, 275 (2024). https://doi.org/10.1007/s00520-024-08487-2

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