ArticleESMO open2023
Time toxicity associated with early phase clinical trial participation.
Article in ESMO open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 1 of them a synthesis that pooled it.
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
25 citing papers in PubMed, 1 synthesis or guideline pooled it, 30 citations in OpenAlex.
- Time toxicity in cancer care: a systematic review of definitions and measurement methods.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Pooled it
- Time toxicity among patients with cancer: a scoping review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Article
- Considering the caregiver in early-phase clinical trials: a review of trial protocols and consent forms.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Review
- The experience of time toxicity in cancer patients: a meta-synthesis of qualitative research.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Review
- Withstanding the test of time for patients in oncology clinical trials.The oncologist · 2026Article
- Planned time burden for patients participating in phase 2 cancer trials.The oncologist · 2026Article
- Article
- Time toxicity associated with treatment of metastatic or unresectable gastro-oesophageal cancers in the second-line setting.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Article
- A novel patient-centered outcome in cancer care, days at home: a scoping review and guide for its future use.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Article
- Oncologist perspectives on the time toxicity of palliative systemic treatments for advanced cancer.JNCI cancer spectrum · 2026Article
- Healthcare workload associated with transition onto kidney replacement therapy: a retrospective cohort study.BMC nephrology · 2025Article
- Inclusion of Older Adults in Early-Phase Cancer Clinical Trials: Safety, Efficacy and a Way Forward.Drugs & aging · 2025Review
- Health Care Contact Days in Older Adults With Metastatic Cancer.JAMA network open · 2025Article
- A personal perspective of patient-centred clinical trials.Oncotarget · 2025Article
- Patient-, care partner-, and clinician-proposed solutions to address the time toxicity of cancer care.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025Article
- Time toxicity of nivolumab in metastatic head and neck squamous cell carcinoma patients: a single-institution experience.Immunotherapy · 2025Article
- Health Care Contact Days and Outcomes in Clinical Trials vs Routine Care Among Patients With Non-Small Cell Lung Cancer.JAMA network open · 2025Article
- Health Care Contact Days for Older Adults Enrolled in Cancer Clinical Trials.JAMA network open · 2025Article
- Evaluating patient diversity in early phase clinical trials in Australia through a prospective multicenter nonrandomized cohort study.JNCI cancer spectrum · 2025Article
- Social and Legal Needs in Patients and Families With Cancer: Interaction With Patient-Level Financial Toxicity.JCO oncology practice · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundEarly phase cancer clinical trials (EPCTs) involve experimental drugs being used for the first time in humans. These studies are designed for dose determination and safety, and represent the most time intensive of all clinical trials for both clinicians and patients. We sought to quantify the amount of patient time consumed through EPCT participation. PATIENTS AND
methodsA retrospective audit of patients treated in the EPCT unit at Liverpool Hospital, Sydney was carried out from 2013 to 2023. We defined 'time toxicity' (TT) as a composite measure where time-toxic days were considered days with any health care system contact, including clinic visits, infusions, procedures or blood work.
resultsA total of 219 patients across 36 EPCTs were included. The median age was 65 years (range 31-81 years). Patients spent a median of 29% (range 4%-100%) of their days in direct contact with the health care system during their study. Protocol-specified visits accounted for the greatest contribution to total TT in 101 (46%) patients. In 7% (n = 16) of patients, unscheduled visits due to either adverse events or cancer-related symptoms accounted for the greatest TT. TT reduced as patients completed additional cycles of treatment. Patients who completed >10 cycles spent 14% of their days interacting with health care systems compared with 35% for those who completed ≤2 cycles. No statistically significant difference in TT was noted between dose-expansion and dose-escalation studies or trials focusing on immune-oncology versus targeted therapy.
conclusionsOur study is the first to report TT in EPCTs with an extended follow-up. Clinicians should be aware of TT when discussing risks and benefits. TT also may not be the appropriate term when describing the time patients invest during EPCTs. Toxicity implies a negative impact, but for many patients, trial participation would be seen as positive. There should be efforts to streamline health care visits to limit TT in EPCTs.
Indexed as
Identifiers
What OpenQuestion holds
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.