ArticleValue in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research2021
Inclusion of Patient-Reported Outcomes in Adolescent and Young Adult Phase III Therapeutic Trials: An Analysis of Cancer Clinical Trials Registered on ClinicalTrials.gov.
Article in Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 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
17 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Time to publication for results of clinical trials.The Cochrane database of systematic reviews · 2024Pooled it
- Patient-reported outcomes in Hodgkin lymphoma trials: a systematic review.Frontiers in oncology · 2024Pooled it
- A systematic review of health-related quality of life outcomes in psychosocial intervention trials for adolescent and young adult cancer survivors.Critical reviews in oncology/hematology · 2023Pooled it
- Longitudinal Health-Related Quality of Life Among Patients With High-Risk Pediatric Hodgkin Lymphoma Treated on the Children's Oncology Group AHOD 1331 Study.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024Trial
- Development of a Health-Related Quality of Life Tool for Adolescents and Young Adults With Cancer.JAMA network open · 2025Article
- Pragmatic paradigm for patient-reported outcome measure selection in lymphoma clinical trials: a rapid review study.BMJ open · 2025Review
- Defining and measuring tolerability in pediatric, adolescent, and young adult oncology: The essential voices.Cancer · 2025Review
- Incorporation of patient-reported outcomes in pediatric cancer clinical trials: design, implementation, and dissemination.Journal of the National Cancer Institute · 2025Article
- Predicting dropout and non-response to psychotherapy for personality disorders: A study protocol focusing on therapist, patient, and the therapeutic relationship.BMC psychology · 2024Article
- Joint Adult and Pediatric Working Group as a Successful Platform to Strengthen Adolescent and Young Adult (AYA) Clinical Trial Collaboration: A Report from the NCTN/SARC AYA Clinical Trials Sarcoma Working Group.Journal of adolescent and young adult oncology · 2023Article
- Colorectal cancer in adolescent and young adults: epidemiology in Japan and narrative review.Journal of gastrointestinal oncology · 2023Review
- Patient-Reported Outcomes in Pediatric Patients With Cancer.American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting · 2023Article
- Inclusion of a core patient-reported outcomes battery in adolescent and young adult cancer clinical trials.Journal of the National Cancer Institute · 2023Article
- Evaluating the role of financial navigation in alleviating financial distress among young adults with a history of blood cancer: A hybrid type 2 randomized effectiveness-implementation design.Contemporary clinical trials · 2023Article
- A Review of Patient-Reported Outcome Measures in Childhood Cancer.Children (Basel, Switzerland) · 2022Review
- Financial toxicity impact on younger versus older adults with cancer in the setting of care delivery.Cancer · 2022Article
- Advances in Hodgkin Lymphoma: Including the Patient's Voice.Frontiers in oncology · 2022Article
Corrections and comments
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Authors and funding
8 authors.
Funding
Abstract
objectivesThere is a paucity of research on the impact of cancer treatment on the health-related quality of life (HRQOL) of adolescent and young adult (AYA) patients with cancer. Patient-reported outcomes (PROs) are self-report measures used to assess HRQOL and symptom burden. The extent to which PROs have been included in trials that include common AYA cancer types has not been previously assessed.
methodsTherapeutic phase 3 trials among common AYA cancer types (Hodgkin lymphoma, non-Hodgkin lymphoma, acute lymphoblastic leukemia, sarcomas, and germ cell tumors) initiated between 2007 and 2020 were identified on ClinicalTrials.gov. The proportions and characteristics of trials including a PRO endpoint were assessed. For comparison with an older population, the proportion of breast and colorectal therapeutic phase 3 trials including PRO endpoints were assessed.
resultsEighty-seven studies met the inclusion criteria. Overall, 20.7% of therapeutic phase 3 AYA trials included a PRO endpoint, and only one trial published PRO data. Germ cell tumors (42.9%) and non-Hodgkin lymphoma (40%) trials had the highest proportions of PRO inclusion. The European Organization for Research and Treatment of Cancer generic, cancer-specific quality of life questionnaire was the most commonly used PRO measure; nevertheless, the measures used varied within and between cancer types. The proportion of trials including a PRO endpoint did not change significantly between 2007 to 2013 and 2014 to 2020 (18.6% vs 22.7%, P=.79).
conclusionsFew therapeutic phase 3 AYA cancer trials include PRO endpoints, fewer publish PRO data, and there is no homogeneity in the measures administered. Therapeutic trials represent an underused opportunity to capture PRO data in the AYA population with the goal of improving HRQOL outcomes.
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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.