A step towards equitable clinical trial recruitment: a protocol for the development and preliminary testing of an online prostate cancer health information and clinical trial matching tool.
Cancer disparities
Clinical trials
Digital health
Prostate cancer
Recruitment science
Journal
Pilot and feasibility studies
ISSN: 2055-5784
Titre abrégé: Pilot Feasibility Stud
Pays: England
ID NLM: 101676536
Informations de publication
Date de publication:
2019
2019
Historique:
received:
20
03
2019
accepted:
15
10
2019
entrez:
14
11
2019
pubmed:
14
11
2019
medline:
14
11
2019
Statut:
epublish
Résumé
Recruitment of a diverse participant pool to cancer clinical trials is an essential component of clinical research as it improves the generalizability of findings. Investigating and piloting novel recruitment strategies that take advantage of ubiquitous digital technologies has become an important component of facilitating broad recruitment and addressing inequities in clinical trial participation. Equitable and inclusive recruitment improves generalizability of clinical trial outcomes, benefiting patients, clinicians, and the research community. The increasing prevalence of online connectivity in the USA and use of the Internet as a resource for medical information provides an opportunity for digital recruitment strategies in cancer clinical trials. This study aims to measure the acceptability, preliminary estimates of efficacy, and feasibility of the Trial Library intervention, an Internet-based cancer clinical trial matching tool. This study will also examine the extent to which the Trial Library website, designed to address the linguistic and literacy needs of broader patient populations, influences patient-initiated conversations with physicians about clinical trial participation. This is a study protocol for a non-randomized, single-arm pilot study. This is a mixed methods study design that utilizes the statistical analysis of quantitative survey data and the qualitative analysis of interview data to assess the participant experience with the Trial Library intervention. This study will examine (1) acceptability as a measure of participant satisfaction with this intervention, (2) preliminary measure of efficacy as a measure of proportion of participants with documented clinical trial discussion in the electronic medical record, and (3) feasibility of the intervention as a measure of duration of clinical visit. The principles that informed the design of the Trial Library intervention aim to be generalizable to clinical trials across many disease contexts. From the ground up, this intervention is built to be inclusive of the linguistic, literacy, and technological needs of underrepresented patient populations. This study will collect essential preliminary data prior to a multi-site randomized clinical trial of the Trial Library intervention. This study has received institutional approval from the Committee of Human Subjects Research at the University of California, San Francisco.
Sections du résumé
BACKGROUND
BACKGROUND
Recruitment of a diverse participant pool to cancer clinical trials is an essential component of clinical research as it improves the generalizability of findings. Investigating and piloting novel recruitment strategies that take advantage of ubiquitous digital technologies has become an important component of facilitating broad recruitment and addressing inequities in clinical trial participation. Equitable and inclusive recruitment improves generalizability of clinical trial outcomes, benefiting patients, clinicians, and the research community. The increasing prevalence of online connectivity in the USA and use of the Internet as a resource for medical information provides an opportunity for digital recruitment strategies in cancer clinical trials. This study aims to measure the acceptability, preliminary estimates of efficacy, and feasibility of the Trial Library intervention, an Internet-based cancer clinical trial matching tool. This study will also examine the extent to which the Trial Library website, designed to address the linguistic and literacy needs of broader patient populations, influences patient-initiated conversations with physicians about clinical trial participation.
METHODS
METHODS
This is a study protocol for a non-randomized, single-arm pilot study. This is a mixed methods study design that utilizes the statistical analysis of quantitative survey data and the qualitative analysis of interview data to assess the participant experience with the Trial Library intervention. This study will examine (1) acceptability as a measure of participant satisfaction with this intervention, (2) preliminary measure of efficacy as a measure of proportion of participants with documented clinical trial discussion in the electronic medical record, and (3) feasibility of the intervention as a measure of duration of clinical visit.
DISCUSSION
CONCLUSIONS
The principles that informed the design of the Trial Library intervention aim to be generalizable to clinical trials across many disease contexts. From the ground up, this intervention is built to be inclusive of the linguistic, literacy, and technological needs of underrepresented patient populations. This study will collect essential preliminary data prior to a multi-site randomized clinical trial of the Trial Library intervention.
TRIAL REGISTRATION
BACKGROUND
This study has received institutional approval from the Committee of Human Subjects Research at the University of California, San Francisco.
Identifiants
pubmed: 31720002
doi: 10.1186/s40814-019-0516-4
pii: 516
pmc: PMC6839161
doi:
Types de publication
Journal Article
Langues
eng
Pagination
123Informations de copyright
© The Author(s). 2019.
Déclaration de conflit d'intérêts
Competing interestsThe authors declare that they have no competing interests.
Références
Cancer Res. 1995 Apr 1;55(7):1485-90
pubmed: 7882357
J Med Internet Res. 2017 Aug 28;19(8):e290
pubmed: 28851679
J Urol. 2019 Feb;201(2):259-267
pubmed: 30218761
Support Care Cancer. 2011 Jan;19(1):49-55
pubmed: 19960208
Patient Educ Couns. 2006 Feb;60(2):102-14
pubmed: 16442453
N Engl J Med. 1999 Dec 30;341(27):2061-7
pubmed: 10615079
Gerontology. 2012;58(2):164-70
pubmed: 21734360
J Health Commun. 2010 Jan;15(1):3-17
pubmed: 20390974
N Engl J Med. 2003 Mar 20;348(12):1170-5
pubmed: 12646676
Cancer. 2014 May 1;120(9):1290-314
pubmed: 24343171
Cancer Causes Control. 2013 May;24(5):979-88
pubmed: 23420328
Ann Surg Oncol. 2007 Dec;14(12):3328-34
pubmed: 17682824
Med Anthropol Q. 2012 Sep;26(3):338-60
pubmed: 23259347
J Clin Oncol. 2003 Feb 1;21(3):413-20
pubmed: 12560428
Ethn Dis. 2000 Winter;10(1):69-75
pubmed: 10764132
J Clin Oncol. 2003 Apr 1;21(7):1383-9
pubmed: 12663731
J Clin Oncol. 2018 Jan 1;36(1):25-33
pubmed: 29035642
Cancer. 1999 Sep 1;86(5):836-41
pubmed: 10463983
BMJ. 2014 Mar 07;348:g1687
pubmed: 24609605
Cancer Control. 2016 Oct;23(4):327-337
pubmed: 27842322
Contemp Clin Trials. 2014 Jul;38(2):275-83
pubmed: 24836075
Ann Oncol. 2012 Jul;23(7):1912-8
pubmed: 22258366
Soc Stud Sci. 2008 Oct;38(5):801-32
pubmed: 19227822
Contemp Clin Trials Commun. 2018 Aug 15;12:60-67
pubmed: 30272035
Cancer. 2014 Apr 1;120 Suppl 7:1113-21
pubmed: 24643649
Palliat Med. 2013 Apr;27(4):375-83
pubmed: 22573470
Health Informatics J. 2008 Mar;14(1):29-38
pubmed: 18258673
Nat Biotechnol. 2009 Oct;27(10):895-902
pubmed: 19816442
JAMA. 2004 Jun 9;291(22):2720-6
pubmed: 15187053
Trials. 2018 Mar 27;19(1):205
pubmed: 29587805
Am J Mens Health. 2008 Jun;2(2):106-21
pubmed: 19477775
Am Soc Clin Oncol Educ Book. 2016;35:185-98
pubmed: 27249699
Trials. 2016 Oct 6;17(1):483
pubmed: 27716378
Trials. 2013 Jun 09;14:166
pubmed: 23758961
JMIR Res Protoc. 2018 Jan 24;7(1):e20
pubmed: 29367186