Literature DB >> 22009665

"Entering a Clinical Trial: Is it Right for You?": a randomized study of The Clinical Trials Video and its impact on the informed consent process.

Brianna Hoffner1, Susan Bauer-Wu, Suzanne Hitchcock-Bryan, Mark Powell, Andrew Wolanski, Steven Joffe.   

Abstract

PURPOSE: This randomized study was designed to assess the utility of an educational video in preparing cancer patients for decisions about clinical trial participation. The study assessed the effect of the video on patients' understanding and perceptions of clinical trials, its impact on decision making and patient-provider communication, and patients' satisfaction with the video.
METHODS: Ninety adults considering cancer clinical trials were randomized to receive (n = 45) or not receive (n = 45) the video. Using the validated Quality of Informed Consent (QuIC), respondents' knowledge about clinical trial participation was assessed. All subjects completed additional questions about satisfaction with the video, decision making, and patient-provider communication. Data were analyzed using the Wilcoxon rank-sum test, regression model, and descriptive statistics.
RESULTS: Although intent-to-treat analysis found no significant group differences in objective understanding between those randomized to view or not view the video, the majority of participants reported favorable experiences with regard to watching the video: 85% found the video was an important source of information about clinical trials; 81% felt better prepared to discuss the trial with their physician; 89% of those who watched the video with family indicated that it helped family better understand clinical trials; and 73% indicated it helped family accept their decision about participation.
CONCLUSIONS: Although the video did not measurably improve patients' knowledge about clinical trials, it was an important source of information, helped educate families, and enhanced patient communication with their oncology providers.
Copyright © 2011 American Cancer Society.

Entities:  

Mesh:

Year:  2011        PMID: 22009665      PMCID: PMC3262890          DOI: 10.1002/cncr.26438

Source DB:  PubMed          Journal:  Cancer        ISSN: 0008-543X            Impact factor:   6.860


  16 in total

1.  Therapeutic misconception and the appreciation of risks in clinical trials.

Authors:  Charles W Lidz; Paul S Appelbaum; Thomas Grisso; Michelle Renaud
Journal:  Soc Sci Med       Date:  2004-05       Impact factor: 4.634

2.  Consent documents for oncology trials: does anybody read these things?

Authors:  S Michael Sharp
Journal:  Am J Clin Oncol       Date:  2004-12       Impact factor: 2.339

3.  Patients' unrealistic hopes for cancer trial benefits may hinder consent.

Authors:  Bridget M Kuehn
Journal:  JAMA       Date:  2011-03-23       Impact factor: 56.272

4.  Quality of informed consent: a new measure of understanding among research subjects.

Authors:  S Joffe; E F Cook; P D Cleary; J W Clark; J C Weeks
Journal:  J Natl Cancer Inst       Date:  2001-01-17       Impact factor: 13.506

5.  Telephone-based nursing intervention improves the effectiveness of the informed consent process in cancer clinical trials.

Authors:  N K Aaronson; E Visser-Pol; G H Leenhouts; M J Muller; A C van der Schot; F S van Dam; R B Keus; C C Koning; W W ten Bokkel Huinink; J A van Dongen; R Dubbelman
Journal:  J Clin Oncol       Date:  1996-03       Impact factor: 44.544

6.  Quality of informed consent in cancer clinical trials: a cross-sectional survey.

Authors:  S Joffe; E F Cook; P D Cleary; J W Clark; J C Weeks
Journal:  Lancet       Date:  2001-11-24       Impact factor: 79.321

7.  Prospective evaluation of cancer clinical trial accrual patterns: identifying potential barriers to enrollment.

Authors:  P N Lara; R Higdon; N Lim; K Kwan; M Tanaka; D H Lau; T Wun; J Welborn; F J Meyers; S Christensen; R O'Donnell; C Richman; S A Scudder; J Tuscano; D R Gandara; K S Lam
Journal:  J Clin Oncol       Date:  2001-03-15       Impact factor: 44.544

8.  Standardized audiotape versus recorded consultation to enhance informed consent to a clinical trial in breast oncology.

Authors:  Thomas F Hack; Tim Whelan; Ivo A Olivotto; Lorna Weir; Barry D Bultz; Bryan Magwood; Fred Ashbury; Jane Brady
Journal:  Psychooncology       Date:  2007-04       Impact factor: 3.894

9.  Improving informed consent to chemotherapy: a randomized controlled trial of written information versus an interactive multimedia CD-ROM.

Authors:  Ian N Olver; Hayley S Whitford; Linley A Denson; Melissa J Peterson; Scott I Olver
Journal:  Patient Educ Couns       Date:  2008-10-21

10.  Communication of randomization in childhood leukemia trials.

Authors:  Eric Kodish; Michelle Eder; Robert B Noll; Kathleen Ruccione; Beverly Lange; Anne Angiolillo; Rebecca Pentz; Stephen Zyzanski; Laura A Siminoff; Dennis Drotar
Journal:  JAMA       Date:  2004-01-28       Impact factor: 56.272

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  15 in total

1.  Multi-Media Educational Tool Increases Knowledge of Clinical Trials in Uganda.

Authors:  Barbara Castelnuovo; Kevin Newell; Yukari C Manabe; Gavin Robertson
Journal:  J Clin Res Bioeth       Date:  2014-01-02

2.  Easy-to-Read Informed Consent Form for Hematopoietic Cell Transplantation Clinical Trials: Results from the Blood and Marrow Transplant Clinical Trials Network 1205 Study.

Authors:  Ryan Spellecy; Sergey Tarima; Ellen Denzen; Heather Moore; Sunil Abhyankar; Peter Dawson; Amy Foley; Iris Gersten; Mitchell Horwitz; Lensa Idossa; Steven Joffe; Naynesh Kamani; Roberta King; Aleksandr Lazaryan; Lawrence Morris; Mary M Horowitz; Navneet S Majhail
Journal:  Biol Blood Marrow Transplant       Date:  2018-04-18       Impact factor: 5.742

3.  A pilot study of simple interventions to improve informed consent in clinical research: feasibility, approach, and results.

Authors:  Nancy E Kass; Holly A Taylor; Joseph Ali; Kristina Hallez; Lelia Chaisson
Journal:  Clin Trials       Date:  2014-12-04       Impact factor: 2.486

4.  A randomized study of multimedia informational aids for research on medical practices: Implications for informed consent.

Authors:  Stephanie A Kraft; Melissa Constantine; David Magnus; Kathryn M Porter; Sandra Soo-Jin Lee; Michael Green; Nancy E Kass; Benjamin S Wilfond; Mildred K Cho
Journal:  Clin Trials       Date:  2016-09-23       Impact factor: 2.486

5.  Informed consent conversations and documents: A quantitative comparison.

Authors:  Shlomo A Koyfman; Chandana A Reddy; Sabahat Hizlan; Angela C Leek; And Eric D Kodish
Journal:  Cancer       Date:  2015-10-27       Impact factor: 6.860

6.  Digital tools in the informed consent process: a systematic review.

Authors:  Francesco Gesualdo; Margherita Daverio; Laura Palazzani; Dimitris Dimitriou; Javier Diez-Domingo; Jaime Fons-Martinez; Sally Jackson; Pascal Vignally; Caterina Rizzo; Alberto Eugenio Tozzi
Journal:  BMC Med Ethics       Date:  2021-02-27       Impact factor: 2.652

Review 7.  Strategies to improve recruitment to randomised trials.

Authors:  Shaun Treweek; Marie Pitkethly; Jonathan Cook; Cynthia Fraser; Elizabeth Mitchell; Frank Sullivan; Catherine Jackson; Tyna K Taskila; Heidi Gardner
Journal:  Cochrane Database Syst Rev       Date:  2018-02-22

8.  Impact of an educational video as a consent tool on knowledge about cure research among patients and caregivers at HIV clinics in South Africa.

Authors:  Melany Hendricks; Gonasagrie Nair; Ciara Staunton; Michael Pather; Nigel Garrett; Dianno Baadjies; Martin Kidd; Keymanthri Moodley
Journal:  J Virus Erad       Date:  2018-04-01

Review 9.  Decision aids for people considering taking part in clinical trials.

Authors:  Katie Gillies; Seonaidh C Cotton; Jamie C Brehaut; Mary C Politi; Zoe Skea
Journal:  Cochrane Database Syst Rev       Date:  2015-11-27

Review 10.  A review of approaches to improve participation of culturally and linguistically diverse populations in clinical trials.

Authors:  Jo-Anne Hughson; Robyn Woodward-Kron; Anna Parker; John Hajek; Agnese Bresin; Ute Knoch; Tuong Phan; David Story
Journal:  Trials       Date:  2016-05-26       Impact factor: 2.279

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