Abstract

Phase I clinical trials (P1Ts) are the first step in testing new medical therapies in humans, and are essential for developing new and innovative therapies for children with cancer. P1Ts are ethically controversial as they are not intended to directly benefit participants, but are particularly controversial for children with cancer who are only able to participate when there is no known curative therapy for their cancer. Benefits of pediatric oncology P1T participation may include improved quality of life (QOL) and hope. Risks may include fostering unrealistic hope, burdening children with additional medical procedures and toxicities, and limiting the opportunity for palliation.

The goal of this dissertation was to investigate the P1T participation experience for children with cancer and their parents by: (1) assessing what is currently known about the participation experience, (2) exploring ways to understand and assess treatment burden and QOL during participation, and (3) interviewing parents about the experience of having a child participate in a P1T. Following a review of the literature, two studies were conducted: a longitudinal pilot study of 13 parent and child dyads who enrolled in a pediatric oncology early phase clinical trial at the recruiting institution, and a phenomenological study of 11 parents of children with cancer who participated in pediatric oncology P1Ts.

Description

This dissertation has also been disseminated through the ProQuest Dissertations and Theses database. Dissertation/thesis number: 10624440; ProQuest document ID: 1991035864. The author still retains copyright.

Author Details

Stacey M. Crane, PhD, RN, CPON

Sigma Membership

Alpha

Type

Dissertation

Format Type

Text-based Document

Study Design/Type

Phenomenology

Research Approach

Qualitative Research

Keywords:

Quality of Life, Research Ethics, Research Participation, Phase I Clinical Trials, Pediatric Oncology

Advisor

Joan E. Haase

Second Advisor

Susan Hickman

Third Advisor

Janet S. Carpenter

Fourth Advisor

Peter Schwartz

Degree

PhD

Degree Grantor

Indiana University

Degree Year

2017

Rights Holder

All rights reserved by the author(s) and/or publisher(s) listed in this item record unless relinquished in whole or part by a rights notation or a Creative Commons License present in this item record.

All permission requests should be directed accordingly and not to the Sigma Repository.

All submitting authors or publishers have affirmed that when using material in their work where they do not own copyright, they have obtained permission of the copyright holder prior to submission and the rights holder has been acknowledged as necessary.

Review Type

None: Degree-based Submission

Acquisition

Proxy-submission

Date of Issue

2022-03-30

Full Text of Presentation

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