Negotiating Decisions during Informed Consent for Pediatric Phase I Oncology Trials

Abstract

During informed consent conferences (ICCs) for Phase I trials, oncologists must present complex information while addressing concerns. Research on communication that evolves during ICCs remains largely unexplored. We examined communication during ICCs for pediatric Phase I cancer trials using a stratified random sample from six pediatric cancer centers. A grounded theory approach identified key communication steps and factors influencing the negotiation of decisions for trial participation. Analysis suggests that during ICCs, families, patients, and clinicians exercise choice and control by negotiating micro-decisions in two broad domains: drug logic and logistics, and administration/scheduling. Micro-decisions unfold in a four-step communication process: (1) introduction of an issue; (2) response; (3) negotiation of the issue; and (4) resolution and decision. Negotiation over smaller micro-decisions is prominent in ICCs and merits further study.

Advancing the field of communication research in pediatric oncology: A systematic review of the literature analyzing medical dialogue

“…The majority of studies ( n = 18, 69%) involved recordings of informed consent conversations . One study recorded conversations at the time of diagnosis, and a minority of studies ( n = 4, 15%) recorded conversations at random visits across the illness trajectory without aiming to capture a specific time point .…”

“…The majority of studies (19/26, 73%) conducted analyses of recorded data using primarily quantitative methods, with application of standardized, validated tools or a priori coding schemata across transcripts to describe frequencies and query associations between values and other demographic features . Five studies (19%) conducted analyses exclusively through traditional qualitative methodology, using standard constant comparative or semantic content analysis to guide the de novo creation of a coding lexicon and subsequently discover themes to inform a conceptual model . Two studies (8%) used mixed methods to integrate quantitative analysis with traditional qualitative methodology …”

“…Three studies (12%) exclusively aimed to describe the content of communication, without qualifying the perceived value or influence of the communication . The remainder of the studies ( n = 23, 88%) presented data with the goal of drawing conclusions about communication quality .…”

“…All articles were published within the last 15 years from the original search date, with half published within the last 5 years. [14][15][16][17][18][19][20][21][22][23][24][25][26][27] The majority of studies (20/26, 77%) were conducted in the United States, 14,15,[20][21][22][23][24][25][27][28][29][30][31][32][33][34][35][36][37][38] with 3 studies from the United Kingdom, 16,18,39 1 study from Brazil, 26 1 from the Netherlands, 17 and 1 from Norway. 19 A total of 8 separate investigative protocols were conducted, resulting in 26 publications.…”

“…19 The majority of studies (n = 18, 69%) involved recordings of informed consent conversations. 14,15,[20][21][22][23][24][28][29][30][31][32][33][34][35][36][37][38] One study recorded conversations at the time of diagnosis, 17 and a minority of studies (n = 4, 15%) recorded conversations at random visits across the illness trajectory without aiming to capture a specific time point. 16,18,26,39 One study recorded conversations at visits following completion of cancer therapy.…”