PMID- 25077043
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231110
IS  - 2161-0711 (Print)
IS  - 2161-0711 (Electronic)
VI  - 4
IP  - 281
DP  - 2014 Apr 24
TI  - Promoting Factors and Barriers to Participation in Early Phase Clinical Trials: 
      Patients Perspectives.
PG  - 1000281
AB  - BACKGROUND: Inclusion of minorities in clinical research is an essential step to 
      develop novel cancer treatments, improve health care overall, understand 
      potential differences in pharmacogenomics and address minorities' 
      disproportionate cancer burden. However, Latinos and other minority groups 
      continue to be critically underrepresented, particularly in early-phase clinical 
      trials (EPCTs). The objective of the present study was to explore barriers and 
      promoting factors influencing patients' decisions to enroll or not in early phase 
      clinical trials (EPCTs) and identify areas for intervention to increase minority 
      enrollment into clinical research. METHODS: An interviewer-administered survey 
      was conducted with 100 cancer patients in the predominantly Latino region of 
      South Texas. Exploratory factor analysis was conducted to identify underlying 
      dimensions, and multiple logistic regression assessed significant factors that 
      promote or deter patients enrollment to EPCTs. In addition, a separate subgroup 
      mean analysis assessed differences by enrollment status and race/ethnicity. 
      RESULTS: For one standard deviation increase in the importance given to the 
      possibility of symptoms improvement, the predicted odds of refusing enrollment 
      were 3.20 times greater (OR=3.20, 95% CI=1.06-9.71, p 0.040). Regarding barriers, 
      among patients who considered fear/uncertainty of the new treatment a deterrent 
      to enrollment, one standard deviation increase in agreement with these barriers 
      was associated with a 3.60 increase (OR=3.60, 95% CI=1.30-9.97h, p 0.014) in the 
      odds of not being enrolled in an EPCT. In contrast, non-enrolled patients were 
      less likely (OR=0.14, 95% CI=0.05-0.44, p 0.001) to consider fatalistic beliefs 
      as an important barrier. CONCLUSION: This study, one of the first to identify 
      South Texas patients' barriers to enroll in EPCTs, highlights potential focal 
      areas to increase participation of both minority and non-minority patients in 
      clinical research. Culturally tailored interventions promoting patient-centered 
      care and bilingual, culturally competent study teams could solve common barriers 
      and enhance Latinos' likelihood of joining clinical trials. These interventions 
      may simultaneously increase opportunities to involve patients and physicians in 
      clinical trials, while ensuring the benefits of participation are equitably 
      distributed to all patients.
FAU - Chalela, Patricia
AU  - Chalela P
AD  - Institute for Health Promotion Research The University of Texas Health Science 
      Center at San Antonio 7411 John Smith Dr., Suite 1000 San Antonio, TX 78229.
FAU - Suarez, Lucina
AU  - Suarez L
AD  - Austin, Texas 78703.
FAU - Munoz, Edgar
AU  - Munoz E
AD  - Institute for Health Promotion Research The University of Texas Health Science 
      Center at San Antonio 7411 John Smith Dr., Suite 1000 San Antonio, TX 78229.
FAU - Gallion, Kipling J
AU  - Gallion KJ
AD  - Institute for Health Promotion Research The University of Texas Health Science 
      Center at San Antonio 7411 John Smith Dr., Suite 1000 San Antonio, TX 78229.
FAU - Pollock, Brad H
AU  - Pollock BH
AD  - Department of Epidemiology and Biostatistics The University of Texas Health 
      Science Center at San Antonio 7703 Floyd Curl Ave., Mail Code 7933 San Antonio, 
      TX 78229-3901.
FAU - Weitman, Steven D
AU  - Weitman SD
AD  - The University of Texas Health Science Center at San Antonio Cancer Therapy & 
      Research Center Institute for Drug Development 7979 Wurzbach Road, Room Z459 San 
      Antonio, Texas 78229.
FAU - Karnad, Anand
AU  - Karnad A
AD  - The University of Texas Health Science Center at San Antonio Cancer Therapy & 
      Research Center Institute for Drug Development 7979 Wurzbach Road, Room Z459 San 
      Antonio, Texas 78229.
FAU - Ramirez, Amelie G
AU  - Ramirez AG
AD  - Institute for Health Promotion Research The University of Texas Health Science 
      Center at San Antonio 7411 John Smith Dr., Suite 1000 San Antonio, TX 78229.
LA  - eng
GR  - P30 CA054174/CA/NCI NIH HHS/United States
GR  - R21 CA101717/CA/NCI NIH HHS/United States
GR  - U54 CA153511/CA/NCI NIH HHS/United States
PT  - Journal Article
PL  - United States
TA  - J Community Med Health Educ
JT  - Journal of community medicine & health education
JID - 101580953
PMC - PMC4112537
MID - NIHMS602267
OTO - NOTNLM
OT  - Barriers
OT  - Cancer Patients
OT  - Clinical Trials
OT  - Early phase
OT  - Enrollment
OT  - Promoters
EDAT- 2014/08/01 06:00
MHDA- 2014/08/01 06:01
PMCR- 2014/07/28
CRDT- 2014/08/01 06:00
PHST- 2014/08/01 06:00 [entrez]
PHST- 2014/08/01 06:00 [pubmed]
PHST- 2014/08/01 06:01 [medline]
PHST- 2014/07/28 00:00 [pmc-release]
AID - 10.4172/2161-0711.1000281 [doi]
PST - ppublish
SO  - J Community Med Health Educ. 2014 Apr 24;4(281):1000281. doi: 
      10.4172/2161-0711.1000281.