Informing Patients About Phase I Trials—How Should It Be Done?

Willems, Yvonne; Sessa, Cristiana

doi:10.3109/02841868909111191

Cited by 12 publications

(13 citation statements)

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“…Furthermore, 11 patients (34%) indicated the response of 'The phase I trial might be ineffective, but I would There is inter-institutional variation in opinions and practices regarding patient selection, including that in the USA (Mick et al, 1994). There seem to be various methods and approaches based on cultural and individual considerations (Willems and Sessa, 1989) in the manner of informing cancer patients about phase I trials. Although much more information is being disclosed to cancer patients than in the past, there is still considerable disagreement and regional differences in Japan about how much information should be conveyed.…”

Section: Discussionmentioning

confidence: 99%

Patients in phase I trials of anti-cancer agents in Japan: motivation, comprehension and expectations

Itoh

Sasaki²,

Fujii³

et al. 1997

Br J Cancer

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Summary We attempted to characterize the motivation, comprehension and expectations of patients who had given informed consent to participate in phase I trials of anti-cancer agents at the National Cancer Center of Japan. Thirty-three patients were given a simple multiplechoice questionnaire and asked to return it at a later date. The completed survey was returned by 32 patients. The patients were surveyed before they had received any investigational phase agents. Nineteen per cent of patients were motivated to participate in the phase trials by the possibility of therapeutic benefit, 9% because participation seemed a better choice than no treatment and only 6% for altruistic reasons. Most patients comprehended the major features of a phase trial, namely its investigational nature, the unknown effects of the agent investigated and the unclear benefit to the patients themselves. Fifty-nine per cent of the patients anticipated that they might suffer severe or life-threatening side-effects if they participated in the phase trial, and 43% were able to indicate accurately the purpose of the phase trial as a dose determination study. Although only a minority of the patients indicated that their motivation to participate was possible treatment benefit to themselves, when answering questions regarding expectations, more than half indicated that there might be personal benefits of varying degrees by participation.

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Section: Discussionmentioning

confidence: 99%

Patients in phase I trials of anti-cancer agents in Japan: motivation, comprehension and expectations

Itoh

Sasaki²,

Fujii³

et al. 1997

Br J Cancer

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“…As a result, ethical concerns arise because some ACPs hold misconceptions about trial objectives and heightened expectations regarding the potential benefits gained by phase I trial participation. [7][8][9][10][11][12] For example, studies have revealed that ACPs report a less-than-ideal understanding of the elements of informed consent (IC), [6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23][24] which are required under federal regulations that govern research. 1,2 These elements include purpose of the research (ie, determination of agents' dose-limiting toxicity), likelihood of benefit, and alternatives to trial participation.…”

Section: Introductionmentioning

confidence: 99%

“…[6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23][24] Although studies have explored ACPs' understanding of the nature of phase I trials, relatively few have documented actual communications between oncologists and ACPs during phase I trial enrollment and compared that to ACP recall of federally required IC elements. [23][24][25][26][27][28][29] Research participation discussions, arguably, should include physician disclosure and patient understanding not only about a particular trial but also about the expected clinical course of the patient's illness. 15,[30][31][32][33][34][35][36][37][38][39][40][41] This seems especially important given that documented ACP median survivals are 6 to 8 months.…”

Section: Introductionmentioning

confidence: 99%

“…[30][31][32][33][34][35][36][37][38][39] As well, ACPs in phase I trials have reported inaccurate prognostic information [13][14][15][30][31][32][33][40][41][42] and have held unrealistic expectations of achievable benefit. [13][14][15][16][17][18][19][20][21][22][23][24] Furthermore, a paucity of information exists about the communication process between oncologists and ACPs who are considering early-phase clinical trial enrollment. [23][24][25][26][27][28][29] One study, however, reported that principal investigators (PIs) often use persuasive approaches when they provide recommendations for trial enrollment, which potentially compromises the IC process.…”

Section: Introductionmentioning

confidence: 99%

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Investigator Disclosure and Advanced Cancer Patient Understanding of Informed Consent and Prognosis in Phase I Clinical Trials

Hlubocky

Kass

Roter

et al. 2018

JOP

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“…There have been three studies 17–19 that have recognized phase 1 consent as a process. Each of these studies tested a pre-specified consent process with a series of three or four consent conversations.…”

Section: Introductionmentioning

confidence: 99%

Description of the types and content of phase 1 clinical trial consent conversations in practice

et al. 2015

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Background/Aims All agree that informed consent is a process, but past research has focused content analyses post-consent or in one conversation in the consent series. Our aim was to identify and describe the content of different types of consent conversations. Methods We 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. Results Four 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. Conclusion We identified and described four types of consent conversations. Our novel findings include 1) four different types of conversations with one – priming – not mentioned before; 2) a change of focus from describing the content of one consent conversation to describing the content of different types. These in-depth descriptions provide the foundation for future research to determine if 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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Informing Patients About Phase I Trials—How Should It Be Done?

Cited by 12 publications

References 1 publication

Patients in phase I trials of anti-cancer agents in Japan: motivation, comprehension and expectations

Patients in phase I trials of anti-cancer agents in Japan: motivation, comprehension and expectations

Investigator Disclosure and Advanced Cancer Patient Understanding of Informed Consent and Prognosis in Phase I Clinical Trials

Description of the types and content of phase 1 clinical trial consent conversations in practice

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