The experiences of children enrolled in pediatric oncology research: Implications for assent

Yoram Unguru, Anne M. Sill, Navnesh Kamani

Research output: Contribution to journalArticle

Abstract

BACKGROUND: Most children with cancer enroll in clinical research trials. Whenever possible, children must provide their assent before enrolling in research studies. We studied what children aged 7 to 18 with cancer understand about research, their research-related treatment, and their preferences for inclusion in decision-making. PROCEDURE; Thirty-seven face-to-face, audiorecorded interviews using a novel, semi-structured tool, the quality-of-assent instrument, were conducted. Exploratory univariate and bivariate analyses of the quantitative data elucidated patterns and trends of understanding and preferences. RESULTS: Nineteen of the 37 children (51%) did not know or recall that their treatment was considered research, and 19 of 22 (86%) did not understand their doctor when he or she discussed the trial. More children enrolled in trials to help future children with cancer (27 of 37 [73%]), than to get better personally (22 of 37 [60%]). Irrespective of age, children with Hodgkin's disease, germ-cell tumors, and leukemia had significantly greater research awareness and appreciation than children with other cancers (P = 019 and P < 001, respectively). Although all children wanted to be involved in decision-making, 18 of 37 (49%) did not have or recall having a role in deciding to enroll in their trial, and 14 of 37 (38%) did not feel free to dissent to trial enrollment. Only 4 of 37 children (11%) discussed increased decision-making roles with parents, and only 7 of 37 (19%) discussed them with their doctors. CONCLUSIONS: Most children have limited understanding of research despite physicians' explanations. Many children reported that they feel minimally involved in the decision to enroll in clinical trials. Tools to assist investigators ascertain that children understand what they are agreeing to when they assent to research and to determine their preferences for inclusion in research may help make assent more meaningful.

Original languageEnglish (US)
JournalPediatrics
Volume125
Issue number4
DOIs
StatePublished - Apr 2010

Fingerprint

Pediatrics
Research
Decision Making
Neoplasms
Clinical Trials
Dissent and Disputes
Germ Cell and Embryonal Neoplasms
Hodgkin Disease
Leukemia
Parents
Research Personnel
Interviews
Physicians
Therapeutics

Keywords

  • Assent
  • Clinical trials
  • Decision-making
  • Preferences
  • Research ethics
  • Understanding

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

Cite this

The experiences of children enrolled in pediatric oncology research : Implications for assent. / Unguru, Yoram; Sill, Anne M.; Kamani, Navnesh.

In: Pediatrics, Vol. 125, No. 4, 04.2010.

Research output: Contribution to journalArticle

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title = "The experiences of children enrolled in pediatric oncology research: Implications for assent",
abstract = "BACKGROUND: Most children with cancer enroll in clinical research trials. Whenever possible, children must provide their assent before enrolling in research studies. We studied what children aged 7 to 18 with cancer understand about research, their research-related treatment, and their preferences for inclusion in decision-making. PROCEDURE; Thirty-seven face-to-face, audiorecorded interviews using a novel, semi-structured tool, the quality-of-assent instrument, were conducted. Exploratory univariate and bivariate analyses of the quantitative data elucidated patterns and trends of understanding and preferences. RESULTS: Nineteen of the 37 children (51{\%}) did not know or recall that their treatment was considered research, and 19 of 22 (86{\%}) did not understand their doctor when he or she discussed the trial. More children enrolled in trials to help future children with cancer (27 of 37 [73{\%}]), than to get better personally (22 of 37 [60{\%}]). Irrespective of age, children with Hodgkin's disease, germ-cell tumors, and leukemia had significantly greater research awareness and appreciation than children with other cancers (P = 019 and P < 001, respectively). Although all children wanted to be involved in decision-making, 18 of 37 (49{\%}) did not have or recall having a role in deciding to enroll in their trial, and 14 of 37 (38{\%}) did not feel free to dissent to trial enrollment. Only 4 of 37 children (11{\%}) discussed increased decision-making roles with parents, and only 7 of 37 (19{\%}) discussed them with their doctors. CONCLUSIONS: Most children have limited understanding of research despite physicians' explanations. Many children reported that they feel minimally involved in the decision to enroll in clinical trials. Tools to assist investigators ascertain that children understand what they are agreeing to when they assent to research and to determine their preferences for inclusion in research may help make assent more meaningful.",
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