SynthesisBMC cancer2019
Health-related quality of life as an endpoint in oncology phase I trials: a systematic review.
Synthesis in BMC cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 3 of them syntheses that pooled it.
What it found
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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
26 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Quality of Life Endpoints in Advanced Gastrointestinal Cancer Trials: Systematic Review of Inclusion, Challenges, and Implications (2020-2024).Clinical oncology (Royal College of Radiologists (Great Britain)) · 2026Pooled it
- Precision Oncology Clinical Trials: A Systematic Review of Phase II Clinical Trials with Biomarker-Driven, Adaptive Design.Cancer research and treatment · 2024Pooled it
- Patient reported outcomes in oncology: changing perspectives-a systematic review.Health and quality of life outcomes · 2022Pooled it
- Patient Versus Clinician Reported Symptoms Agreement in Advanced Metastatic Bladder Cancer Patients.Cancer medicine · 2025Trial
- Cardiopulmonary-related patient-reported outcomes in a randomized clinical trial of radiation therapy for breast cancer.BMC cancer · 2021Trial
- Patient-Reported Outcomes in Early-Phase Oncology Clinical Trials: A Stepping Stone to a Patient-Centered Drug Development.The patient · 2026Review
- Measuring What Matters: RECIST Response Does Not Predict HRQoL in Early-Phase Clinical Trials.Cancers · 2026Article
- Prospective assessment of health-related quality of life in early phase oncology clinical trials: PEARLER.JNCI cancer spectrum · 2025Article
- Review
- Factors Associated with Health-Related Quality of Life Among Breast Cancer Survivors in Saudi Arabia: Cross-Sectional Study.Asian Pacific journal of cancer prevention : APJCP · 2024Article
- Analysis of oncological drugs authorised in Spain in the last decade: association between clinical benefit and reimbursement.The European journal of health economics : HEPAC : health economics in prevention and care · 2024Article
- Health-related quality of life outcomes reporting associated with FDA approvals in haematology and oncology.BMJ oncology · 2024Article
- Statistical methods and data visualisation of patient-reported outcomes in early phase dose-finding oncology trials: a methodological review.EClinicalMedicine · 2023Article
- Evaluation of supportive care needs, sexuality and quality of life in phase 1 trials: a prospective monocentric study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2022Article
- Patient-Reported Outcomes in Early Phase Clinical Trials: An Opportunity to Actively Promote Patient-Centered Care.The oncologist · 2022Article
- Using Patient-Reported Outcomes in Dose-Finding Oncology Trials: Surveys of Key Stakeholders and the National Cancer Research Institute Consumer Forum.The oncologist · 2022Article
- Validation of the BC-Brain Patient-Reported Outcome Questionnaire for Patients with Central Nervous System Tumours Treated with Radiotherapy.Current oncology (Toronto, Ont.) · 2022Article
- Adding a fatigue item to the EQ-5D-5L improves its psychometric performance in the general population.Journal of patient-reported outcomes · 2022Article
- The value of patient-reported outcomes in early-phase clinical trials.Nature medicine · 2022Article
- Trends in patient-reported outcome use in early phase dose-finding oncology trials - an analysis of ClinicalTrials.gov.Cancer medicine · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPhase I trials aim to identify the recommended dose for further development. Health-related quality of life (HRQoL) could be a complement to the usual National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) scale to detect adverse events and define the doses. The objective of this study is to review the phase I in oncology which used HRQoL as endpoint.
methodsA search in PubMed database identified phase I trials in oncology with HRQoL as endpoint, published between January 2012 to May 2016. Hematological and pediatric phase I were excluded.
resultsA total of 1333 phase I were identified and 15 trials were identified with HRQoL as endpoint (1.1%). The European Organisation for Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) was the most frequently used instrument: 5 studies (33.3%). The targeted dimensions of HRQoL and the minimal clinically important difference were prespecified in 1 study (6.7%) and 2 studies (13.3%), respectively. Twelve studies (80%) described the statistical approach to analyze HRQoL data. Eight studies used the mean change from baseline (60%) to analyse longitudinal HRQoL data, two the mean score at certain times (13.3%), one the linear mixed model for repeated measures (6.7%), one the time to HRQoL score deterioration (6.7%), one percentage of patient-reported symptoms (6.7%). None of the studies used HRQoL to determine the recommended doses.
conclusionFew phase I studies used HRQoL as endpoint and among studies with HRQoL as endpoint, the methodology of HRQoL measurement and statistical analysis was heterogeneous. HRQoL. endpoint not used for assessing the recommended phase II doses.
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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.