Literature DB >> 31603726

Before Consent: Qualitative Analysis of Deliberations of Patients With Advanced Cancer About Early-Phase Clinical Trials.

Sarah B Garrett1, Thea M Matthews1, Corey M Abramson2, Christopher J Koenig3, Fay J Hlubocky4, Christopher K Daugherty4, Pamela N Munster1, Daniel Dohan1.   

Abstract

PURPOSE: Patients with advanced cancer and oncologists deliberate about early-phase (EP) trials as they consider whether to pursue EP trial enrollment. We have limited information about those deliberations and how they may facilitate or impede trial initiation. This study describes these deliberations and their relationship to trial initiation. PATIENTS AND METHODS: We collected longitudinal, ethnographic data on deliberations of patients with advanced cancer at two academic medical centers. We used constant comparative and framework analyses to characterize the deliberative process and its relationship to trial initiation.
RESULTS: Of 96 patients with advanced cancer, 26% initiated EP enrollment and 19% joined a trial. Constant comparative analysis revealed two foci of deliberation. Setting the stage focused on patient and physician support for EP trial involvement, including patients' interest in research and oncologists' awareness of trials and assessment of patient fit. Securing a seat focused on eligibility for and entrance to a specific trial and involved trial availability, treatment history, disease progression, and enrollment timing. Patients enrolled in a trial only when both stages could be successfully navigated.
CONCLUSION: Ethnographic data revealed two foci of deliberation about EP trial enrollment among patients with advanced cancer. Physician support played a consequential role in both stages, but enrollment also reflected factors beyond the control of any specific individual. Insights from this study, combined with other recent studies of trial enrollment, advance our understanding of the complex process of EP trial accrual and may help identify strategies to improve rates of participation.

Entities:  

Mesh:

Year:  2019        PMID: 31603726      PMCID: PMC6993554          DOI: 10.1200/JOP.19.00256

Source DB:  PubMed          Journal:  JCO Oncol Pract        ISSN: 2688-1527


  37 in total

1.  Informed consent, the cancer patient, and phase I clinical trials.

Authors:  C K Daugherty
Journal:  Cancer Treat Res       Date:  2000

2.  Deliberation and the life cycle of informed consent.

Authors:  Steven Joffe; Jennifer W Mack
Journal:  Hastings Cent Rep       Date:  2014 Jan-Feb       Impact factor: 2.683

Review 3.  Is Participation in Cancer Phase I Trials Really Therapeutic?

Authors:  Jonathan Kimmelman
Journal:  J Clin Oncol       Date:  2016-09-30       Impact factor: 44.544

4.  Interest in initiating an early phase clinical trial: results of a longitudinal study of advanced cancer patients.

Authors:  Laura B Dunn; Jim Wiley; Sarah Garrett; Fay Hlubocky; Christopher Daugherty; Laura Trupin; Pamela Munster; Daniel Dohan
Journal:  Psychooncology       Date:  2016-06-20       Impact factor: 3.894

Review 5.  Strategies addressing barriers to clinical trial enrollment of underrepresented populations: a systematic review.

Authors:  Caren Heller; Joyce E Balls-Berry; Jill Dumbauld Nery; Patricia J Erwin; Dawn Littleton; Mimi Kim; Winston P Kuo
Journal:  Contemp Clin Trials       Date:  2014-08-15       Impact factor: 2.226

6.  Early-phase clinical trials in the community: results from the national cancer institute community cancer centers program early-phase working group baseline assessment.

Authors:  Howard A Zaren; Suresh Nair; Ronald S Go; Rebecca A Enos; Keith S Lanier; Michael A Thompson; Jinxiu Zhao; Deborah L Fleming; John C Leighton; Thomas E Gribbin; Donna M Bryant; Angela Carrigan; Jennifer C Corpening; Kimberly A Csapo; Eileen P Dimond; Christie Ellison; Maria M Gonzalez; Jodi L Harr; Kathy Wilkinson; Andrea M Denicoff
Journal:  J Oncol Pract       Date:  2013-03       Impact factor: 3.840

7.  Broadening Eligibility Criteria to Make Clinical Trials More Representative: American Society of Clinical Oncology and Friends of Cancer Research Joint Research Statement.

Authors:  Edward S Kim; Suanna S Bruinooge; Samantha Roberts; Gwynn Ison; Nancy U Lin; Lia Gore; Thomas S Uldrick; Stuart M Lichtman; Nancy Roach; Julia A Beaver; Rajeshwari Sridhara; Paul J Hesketh; Andrea M Denicoff; Elizabeth Garrett-Mayer; Eric Rubin; Pratik Multani; Tatiana M Prowell; Caroline Schenkel; Marina Kozak; Jeff Allen; Ellen Sigal; Richard L Schilsky
Journal:  J Clin Oncol       Date:  2017-10-02       Impact factor: 44.544

8.  Patient information in phase 1 trials: A systematic review.

Authors:  Katrine Toubro Gad; Ulrik Lassen; Morten Mau-Søerensen; Mette Terp Høybye; Christoffer Johansen
Journal:  Psychooncology       Date:  2017-10-26       Impact factor: 3.894

9.  Barriers in phase I cancer clinical trials referrals and enrollment: five-year experience at the Princess Margaret Hospital.

Authors:  Jeremy Ho; Gregory R Pond; Colin Newman; Martha Maclean; Eric X Chen; Amit M Oza; Lillian L Siu
Journal:  BMC Cancer       Date:  2006-11-08       Impact factor: 4.430

10.  A Case-Control Study Brings to Light the Causes of Screen Failures in Phase 1 Cancer Clinical Trials.

Authors:  Emmanuelle Kempf; Nathalie Lemoine; Gabrielle Tergemina-Clain; Anthony Turpin; Sophie Postel-Vinay; Emilie Lanoy; Jean-Charles Soria; Christophe Massard; Antoine Hollebecque
Journal:  PLoS One       Date:  2016-05-05       Impact factor: 3.240

View more
  1 in total

1.  Decision-making about clinical trial options among older patients with metastatic cancer who have exhausted standard therapies.

Authors:  Mazie Tsang; Rebecca J DeBoer; Sarah B Garrett; Daniel Dohan
Journal:  J Geriatr Oncol       Date:  2022-02-04       Impact factor: 3.929

  1 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.