title: A Qualitative Study of Phase III Cancer Clinical Trial Enrollment Decision-Making: Perspectives from Adolescents, Young Adults, Caregivers, and Providers.
abstract: Purpose:The mortality reduction rate for adolescents and young adults (AYAs) with cancer has not demonstrated the same rate of improvement as for children, due partly to insufficient phase III cancer clinical trial enrollment. This study describes three key components of phase III cancer clinical trial enrollment-family decision-making patterns, factors that influence AYAs' involvement, and attitudes (perceived barriers and benefits) toward trial participation-and evaluated a measure of attitudes.Methods:Participants were AYAs (15-23 years old at study) diagnosed with cancer and offered a phase III cancer clinical trial within the past 3-21 months, their primary caregivers, and their healthcare providers. Interviews assessed: (a) phase III clinical trial decision-making experiences and (b) relevance of the Pediatric Research Participation Questionnaire (PRPQ) in the assessment of AYAs' attitudes toward enrollment on phase III cancer clinical trials.Results:Thirteen AYAs, 16 caregivers, and 11 providers were interviewed. Four decision-making patterns were identified, withAYA abdicates to caregiverandcaregiver-based and AYA-endorsedthe most commonly described, but with variation across respondents. Distress and reduced health-related quality of life limited AYAs' involvement in the enrollment decision, while developmental and emotional maturity facilitated involvement. Perceived barriers and benefits to enrollment were reported, and the PRPQ was deemed relevant with minor modifications.Conclusions:Findings suggest that AYAs may not be fully involved in phase III cancer clinical trial enrollment decision-making, and caregivers and providers are challenged to overcome factors that limit their involvement. The PRPQ shows promise as a tool for systematically evaluating clinical trial attitudes.
authors.affiliation: The Children's Hospital of Philadelphia , Philadelphia, Pennsylvania. ; Perelman School of Medicine of the University of Pennsylvania , Philadelphia, Pennsylvania.
authors.forename: Lamia P
authors.initials: LP
authors.lastname: Barakat
authors.affiliation: The Children's Hospital of Philadelphia , Philadelphia, Pennsylvania. ; Perelman School of Medicine of the University of Pennsylvania , Philadelphia, Pennsylvania.
authors.forename: Lisa A
authors.initials: LA
authors.lastname: Schwartz
authors.affiliation: The Children's Hospital of Philadelphia , Philadelphia, Pennsylvania. ; Perelman School of Medicine of the University of Pennsylvania , Philadelphia, Pennsylvania.
authors.forename: Anne
authors.initials: A
authors.lastname: Reilly
authors.affiliation: The Children's Hospital of Philadelphia , Philadelphia, Pennsylvania. ; University of Pennsylvania School of Nursing , Philadelphia, Pennsylvania.
authors.forename: Janet A
authors.initials: JA
authors.lastname: Deatrick
authors.affiliation: The Children's Hospital of Philadelphia , Philadelphia, Pennsylvania. ; Perelman School of Medicine of the University of Pennsylvania , Philadelphia, Pennsylvania.
authors.forename: Frank
authors.initials: F
authors.lastname: Balis
keywords: attitudes to clinical trials; clinical trial participation; perceived barriers and benefits to research; treatment decision-making