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Knowledge and understanding among cancer patients consenting to participate in clinical trials
Abstract
The aim of this study was to explore the fulfilment of the requirements of informed consent in patients participating in cancer clinical trials. All patients consenting to a phase II or III clinical trial during one year were included (n=325, 176 women, 54%). Data were collected by a questionnaire, Quality of Informed Consent. The response rate was 87%. High levels of knowledge (>80%) were found for items concerning voluntariness, randomisation, benefits for future patients, participation in a research trial, and the right to withdraw. Less than 50% responded correctly to items about risks associated with the trial, the unproven nature of the trial and issues about insurances. High levels of perceived understanding were reported. Despite high levels of knowledge and perceived understanding in the majority of elements of informed consent, improvements are warranted regarding knowledge about risks, the unproven nature of the treatment and the duration of treatment.
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Many participants, including biobank participants, do not understand the information disclosed to them.
“and, not surprisingly, many participants do not understand the information disclosed (4–6,70,71, 83, 87, 97), including biobank participants (93,104,114).”
From Lessons from HeLa Cells: The Ethics and Policy of Biospecimens (2016) · cites this paper as [6]
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References 12 · Cited by 62
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Metadata
- Authors
- Bergenmar, M., Molin, C., Wilking, N., & Brandberg, Y.
- Affiliations
- Karolinska University Hospital (SE)
- Corresponding author
- Bergenmar, Mia
- Venue
- European Journal of Cancer
- Publisher
- Elsevier BV
- Published
- 2008-11
- Volume
- 44
- Issue
- 17
- Pages
- 2627-2633
- ISSN
- 0959-8049 (ISSN-L)
- OpenAlex
- W2134123342
- Cited by
- 62
- References
- 12
- Citations by year
- 2026: 1 · 2025: 5 · 2024: 2 · 2022: 1 · 2021: 4 · 2019: 4 · 2018: 2 · 2017: 1 · 2016: 6 · 2015: 7 · 2014: 7 · 2013: 4 · 2012: 5
- FWCI
- 4.29
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- European Journal of Cancer (publishedVersion)
- PubMed (publishedVersion)
- DigitalGeorgetown (Georgetown University Library) (submittedVersion)
- Funders
- Cancerfonden
- Stockholms Läns Landsting
- Cancerföreningen i Stockholm
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics and bioethics in healthcare
- Health Sciences › Health Professions › General Health Professions › Patient-Provider Communication in Healthcare
- Keywords
- informed consent, cancer clinical trials, patient knowledge, perceived understanding, randomization, right of withdrawal, treatment duration, insurance coverage, women with cancer
- MeSH terms
- Adolescent, Adult, Aged, Female, Humans, Informed Consent, Health Knowledge, Attitudes, Practice, Male, Middle Aged, Neoplasms, Surveys and Questionnaires, Clinical Trials, Phase II as Topic, Clinical Trials, Phase III as Topic, Comprehension, Young Adult
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