Parental decision making regarding consent to randomization on Children's Oncology Group AALL0932. 2021

Kellee Parker, and Erika Cottrell, and Linda Stork, and Susan Lindemulder
Division of Pediatric Hematology and Oncology, Department of Pediatrics, Oregon Health and Science University, Portland, Oregon.

Within pediatric oncology, parental decision making regarding participation in clinical trials that aim to reduce therapy to mitigate side effects is not well studied. The recently completed Children's Oncology Group trial for standard-risk acute lymphoblastic leukemia (AALL0932) included a reduction in maintenance therapy, and required consent for randomization immediately prior to starting maintenance. At our institution, 40% of children enrolled on AALL0932 were withdrawn from protocol therapy prior to randomization due to parental choice. This study sought to identify factors that impacted parental decision making regarding randomization on AALL0932. Parents of children enrolled on AALL0932 at our institution were eligible if their child met criteria for the average-risk randomization. Parents were invited to participate in a 30-50-minute phone interview. Questions focused on factors that shaped parental decision making about randomization, as well as their perspectives about the clinical trial experience more generally. Fear of receiving less therapy and subsequent relapse was the predominant reason to decline randomization. Reasons given for consenting to randomization included trust in the physician, altruism, hope for less therapy, and potential for fewer side effects. Parents also reflected on ways to support future families making decisions about clinical trial participation. While many parents recognize the importance of clinical trials aiming to mitigate side effects, the fear of their own child relapsing with less than standard therapy may dissuade them from study participation. Recognizing and addressing these concerns will be important for enrollment and retention in future clinical trials.

UI MeSH Term Description Entries
D007223 Infant A child between 1 and 23 months of age. Infants
D008297 Male Males
D010290 Parents Persons functioning as natural, adoptive, or substitute parents. The heading includes the concept of parenthood as well as preparation for becoming a parent. Step-Parents,Parental Age,Parenthood Status,Stepparent,Age, Parental,Ages, Parental,Parent,Parental Ages,Status, Parenthood,Step Parents,Step-Parent,Stepparents
D002648 Child A person 6 to 12 years of age. An individual 2 to 5 years old is CHILD, PRESCHOOL. Children
D002675 Child, Preschool A child between the ages of 2 and 5. Children, Preschool,Preschool Child,Preschool Children
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults
D000970 Antineoplastic Agents Substances that inhibit or prevent the proliferation of NEOPLASMS. Anticancer Agent,Antineoplastic,Antineoplastic Agent,Antineoplastic Drug,Antitumor Agent,Antitumor Drug,Cancer Chemotherapy Agent,Cancer Chemotherapy Drug,Anticancer Agents,Antineoplastic Drugs,Antineoplastics,Antitumor Agents,Antitumor Drugs,Cancer Chemotherapy Agents,Cancer Chemotherapy Drugs,Chemotherapeutic Anticancer Agents,Chemotherapeutic Anticancer Drug,Agent, Anticancer,Agent, Antineoplastic,Agent, Antitumor,Agent, Cancer Chemotherapy,Agents, Anticancer,Agents, Antineoplastic,Agents, Antitumor,Agents, Cancer Chemotherapy,Agents, Chemotherapeutic Anticancer,Chemotherapy Agent, Cancer,Chemotherapy Agents, Cancer,Chemotherapy Drug, Cancer,Chemotherapy Drugs, Cancer,Drug, Antineoplastic,Drug, Antitumor,Drug, Cancer Chemotherapy,Drug, Chemotherapeutic Anticancer,Drugs, Antineoplastic,Drugs, Antitumor,Drugs, Cancer Chemotherapy
D016032 Randomized Controlled Trials as Topic Works about clinical trials that involve at least one test treatment and one control treatment, concurrent enrollment and follow-up of the test- and control-treated groups, and in which the treatments to be administered are selected by a random process, such as the use of a random-numbers table. Clinical Trials, Randomized,Controlled Clinical Trials, Randomized,Trials, Randomized Clinical

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