Levels of knowledge and perceived understanding among participants in cancer clinical trials – factors related to the informed consent procedure
Abstract
Background An informed consent from patients participating in cancer clinical trials is mandatory according to international and national guidelines and laws. Insufficient knowledge and understanding by trial participants have been reported in several studies. Purpose The aims of this study were to investigate factors of importance for knowledge and understanding about cancer clinical trials among trial participants. Methods All patients consenting to a phase II or III clinical trial during 1 year were invited ( n = 325). Data on knowledge and perceived understanding were collected by a questionnaire, Quality of Informed Consent. Results are based on data from 268 patients (82%). Associations between knowledge and perceived understanding as well as clinical, socio-economic factors, and factors related to the informed consent procedure were tested. Results In the multivariate analysis no statistically significant associations were found between knowledge and any of the factors. Patients who reported longer time for trial information before their decision to participate, those who found the decision easy to take, and patients who reported use of other information sources had statistically significant higher perceived understanding. No differences in mean scores for knowledge or perceived understanding were found for any of the clinical factors (age, gender, diagnostic group, trial phase), socio-economic factors (education, marital status), and the following factors related to the informed consent procedure; presence of relative or nurse at information about the trial or previous participation in clinical trials. Limitations No study specific questions were included due to the number of trials ( n = 35). Conclusion Strategies to increase patients’ knowledge needs to be elaborated in order to improve the fulfilment of the requirements of informed consent in participants in cancer clinical trials.
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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 [5]
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Beskow, L. M. (2016) · Annual Review of Genomics and Human Genetics · doi:10.1146/annurev-genom-083115-022536 · Cited by 146 · see citing works
Dellson, P., Nilsson, K., Jernström, H., & Carlsson, C. (2018) · Trials · doi:10.1186/s13063-018-2916-9 · Cited by 58 · see citing works
- Authors
- Bergenmar, M., Johansson, H., & Wilking, N.
- Affiliations
- Karolinska University Hospital (SE)
- Karolinska Institutet (SE)
- Corresponding author
- Bergenmar, Mia
- Venue
- Clinical Trials
- Publisher
- SAGE Publications
- Published
- 2010-11-25
- Volume
- 8
- Issue
- 1
- Pages
- 77-84
- ISSN
- 1740-7745 (ISSN-L)
- 1740-7753
- OpenAlex
- W2048952536
- Cited by
- 49
- References
- 0
- Citations by year
- 2026: 1 · 2025: 4 · 2024: 4 · 2023: 1 · 2022: 2 · 2021: 3 · 2019: 7 · 2018: 4 · 2017: 2 · 2016: 5 · 2015: 6 · 2014: 2 · 2013: 3 · 2012: 2
- FWCI
- 2.54
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Clinical Trials (publishedVersion)
- PubMed (publishedVersion)
- 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, trial participants, socioeconomic factors
- MeSH terms
- Adult, Aged, Clinical Trials as Topic, Female, Humans, Informed Consent, Health Knowledge, Attitudes, Practice, Male, Middle Aged, Neoplasms, Patient Education as Topic, Perception, Surveys and Questionnaires, Socioeconomic Factors, Sweden, Multivariate Analysis
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