scholarly journals Well-Being of Child and Family Participants in Phase 1 Pediatric Oncology Clinical Trials

2018 ◽  
Vol 45 (5) ◽  
pp. E67-E97 ◽  
Author(s):  
Stacey Crane ◽  
Joan Haase ◽  
Susan Hickman
Keyword(s):  
Clinical Trials ◽  
Pediatric Oncology ◽  
Phase 1 ◽  
Well Being ◽  
Oncology Clinical Trials

Parental insights into phase I pediatric oncology clinical trials: Findings from a phenomenological study.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e21534-e21534
Author(s):  
Stacey Crane ◽  
James Croop ◽  
Jill Lunsford Lee ◽  
Jamie Walski ◽  
Joan Haase
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Childhood Cancer ◽  
Pediatric Oncology ◽  
Phenomenological Study ◽  
Medical Center ◽  
Well Being ◽  
Phase I Clinical Trials ◽  
Curative Therapy ◽  
Oncology Clinical Trials

e21534 Background: Phase I clinical trials (P1Ts) are an essential step in the validation of novel therapies to treat childhood cancer. Children with cancer participate in P1Ts when no known curative therapy remains for their cancer. It is important to understand the experiences of children with advanced cancer and their families in P1Ts to ensure that participation supports the participants’ well-being. Methods: An empirical phenomenology study, using an adapted Colaizzi method, was conducted of 11 parents’ lived experiences of their child’s participation in pediatric oncology P1Ts. Parents were recruited from two pediatric academic medical centers in the Midwest United States and from national childhood cancer groups not affiliated with either medical center. Parents participated in individual interviews (mean length 59.1 minutes), with one broad data-generating question. Demographics and the child’s clinical trial records provided additional context for understanding the experiences. This presentation describes the study themes identified that were specifically related to pediatric oncology P1T processes and logistics. Results: Parents’ experiences during the P1Ts were primarily positive. However, data analysis revealed five aspects of P1T participation that were problematic for parents to varying degrees. These aspects were: (1) Learning About Clinical Trials, (2) Being Referred to Another Institution, (3) Undergoing Research-Only Procedures, (4) Complying with the Trial Requirements, and (5) Taking Oral Medications. Conclusions: While overall experiences during P1T participation were positive, improvements can be made that could potentially enhance participants’ experiences. In particular, enhancing the education provided to participants during on-trial processes and minimizing the logistical burdens associated with P1T requirements may help to address problematic aspects of P1Ts.

scholarly journals Parental perceptions of the informed consent process in pediatric oncology clinical trials

2013 ◽  
Vol 3 (11) ◽  
Author(s):  
Yvonne D Hastings ◽  
Natalie K Bradford ◽  
Liane R Lockwood ◽  
Robert S Ware ◽  
Jeanine Young
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Pediatric Oncology ◽  
Parental Perceptions ◽  
Informed Consent Process ◽  
Consent Process ◽  
Oncology Clinical Trials

Challenges in incentivizing the pharmaceutical industry to supporting pediatric oncology clinical trials

2013 ◽  
Vol 3 (2) ◽  
pp. 101-103 ◽  
Author(s):  
Paola Angelini ◽  
Kathryn Pritchard-Jones ◽  
Darren R Hargrave
Keyword(s):  
Clinical Trials ◽  
Pharmaceutical Industry ◽  
Pediatric Oncology ◽  
Oncology Clinical Trials

scholarly journals Pre-clinical animal models are poor predictors of human toxicities in phase 1 oncology clinical trials

2020 ◽  
Vol 123 (10) ◽  
pp. 1496-1501
Author(s):  
Johnique T. Atkins ◽  
Goldy C. George ◽  
Kenneth Hess ◽  
Kathrina L. Marcelo-Lewis ◽  
Ying Yuan ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Animal Models ◽  
Phase 1 ◽  
Oncology Clinical Trials

PCN210 Patient-Reported Outcomes in Commercial Pediatric Oncology Clinical Trials

2021 ◽  
Vol 24 ◽  
pp. S59
Author(s):  
M. Murugappan ◽  
B.L. King-Kallimanis ◽  
G.H. Reaman ◽  
V. Bhatnagar ◽  
E.G. Horodniceanu ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Pediatric Oncology ◽  
Patient Reported Outcomes ◽  
Patient Reported ◽  
Oncology Clinical Trials

scholarly journals Who Needs What? Perceptions of Patients and Caregivers in Oncology Phase 1 Trials

2019 ◽  
Vol 7 (1) ◽  
pp. 27-33 ◽  
Author(s):  
Victoria Rezash ◽  
Janice Reed ◽  
Barbara Gedeon ◽  
Eric Parsons ◽  
Sandra Siedlecki ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Phase 1 ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
Oncology Clinical Trial ◽  
Oncology Clinical Trials ◽  
Vulnerable Patient ◽  
Additional Support

Background: The study design and nature of oncology phase 1 clinical trials create a uniquely vulnerable patient population yet little research has been conducted to identify the added burden these trials create for both cancer patients and their caregiver(s). Objective: Examining the perceptions and needs of patients and their caregivers participating in phase 1 oncology clinical trials, the investigators tested the hypothesis that the caregiver will exhibit a higher level of burden and/or distress than the patient. Method: A mixed-methods exploratory process utilizing patient and caregiver interviews and quality-of-life questionnaires was used to assess the psychosocial burdens associated with oncology clinical trial participation. A qualitative and quantitative analysis of the responses were 8 performed. Result: Both patients and caregivers reported similar themes identifying the burdens and benefits related to phase 1 clinical trial participation. However, the caregivers’ expressed burden exceeded that of the patients’ validating the study’s hypothesis. Conclusion: The need for ongoing additional support services for not only the patient but also the caregiver was identified.

Minority participation in phase 1 gynecologic oncology clinical trials: Three decades of inequity

2020 ◽  
Vol 157 (3) ◽  
pp. 729-732 ◽  
Author(s):  
Eli Awad ◽  
Rajesh Paladugu ◽  
Nathaniel Jones ◽  
Jennifer Young Pierce ◽  
Jennifer Scalici ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Phase 1 ◽  
Gynecologic Oncology ◽  
Minority Participation ◽  
Oncology Clinical Trials
Sign in / Sign up

Export Citation Format

Share Document