ArticleClinical trials (London, England)2015
Description of the types and content of phase 1 clinical trial consent conversations in practice.
Article in Clinical trials (London, England), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
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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
9 citing papers in PubMed.
- Trusting relationships between patients with non-curative cancer and healthcare professionals create ethical obstacles for informed consent in clinical trials: a grounded theory study.BMC palliative care · 2023Article
- Evaluating the impact of the Patient Preference Assessment Tool on clinicians' recommendations for phase I oncology clinical trials.Psycho-oncology · 2021Article
- Nothing to lose: a grounded theory study of patients' and healthcare professionals' perspectives of being involved in the consent process for oncology trials with non-curative intent.BMC palliative care · 2020Article
- Provider Recommendations for Phase I Clinical Trials Within a Shared Decision-Making Model in Phase I Cancer Clinical Trial Discussions.JCO oncology practice · 2020Article
- Before Consent: Qualitative Analysis of Deliberations of Patients With Advanced Cancer About Early-Phase Clinical Trials.JCO oncology practice · 2020Article
- Investigator Disclosure and Advanced Cancer Patient Understanding of Informed Consent and Prognosis in Phase I Clinical Trials.Journal of oncology practice · 2018Article
- What advanced cancer patients with limited treatment options know about clinical research: a qualitative study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2017Article
- Discussing molecular testing in oncology care: Comparing patient and physician information preferences.Cancer · 2017Article
- Ovarian cancer patients' and their family members' perspectives on novel vaccine and virotherapy trials.Clinical trials (London, England) · 2016Article
Corrections and comments
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Authors and funding
6 authors.
Funding
Abstract
BACKGROUND OR
aimsAll agree that informed consent is a process, but past research has focused content analyses on post-consent or on one conversation in the consent series. Our aim was to identify and describe the content of different types of consent conversations.
methodsWe conducted a secondary analysis of 38 adult oncology phase 1 consent conversations, which were audio-recorded, transcribed, coded, and qualitatively analyzed for type and content.
resultsFour types of consent conversations were identified: (1) priming, (2) patient-centered options, (3) trial centered, and (4) decision made. The analysis provided a robust description of the content discussed in each type of conversation. Two themes, supportive care and prognosis, were rarely mentioned. Four themes clustered in the patient-centered (type 2) conversations: affirmation of honesty, comfort, progression, and offer of supportive care.
conclusionWe identified and described four types of consent conversations. Our novel findings include (1) four different types of conversations with one (priming) not mentioned before and (2) a change of focus from describing the content of one phase 1 consent conversation to describing the content of different types. These in-depth descriptions provide the foundation for future research to determine whether the four types of conversations occur in sequence, thus describing the structure of the consent process and providing the basis for coaching interventions to alert physicians to the appropriate content for each type of conversation. A switch from a focus on one conversation to the types of conversations in the process may better align the consent conversations with the iterative process of shared decision making.
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Registered trials
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