Strategies for recruitment to a population-based lung cancer prevention trial: the CARET experience with heavy smokers. Beta-Carotene and Retinol Efficacy Trial.
Cancer Epidemiol Biomarkers Prev
; 7(5): 405-12, 1998 May.
Article
in En
| MEDLINE
| ID: mdl-9610790
ABSTRACT
The Beta-Carotene and Retinol Efficacy Trial tested the effect of the combination of beta-carotene (30 mg) and retinyl palmitate (25,000 units) daily on the incidence of lung cancer in high-risk individuals. In study centers located in Seattle, WA; Portland, OR; and Irvine, CA, we recruited current and recent ex-cigarette smokers, aged 50-69 years. Our primary method of recruitment was by mailing study information and eligibility questionnaires to age-selected health insurance subscribers. A total of 1,216,549 subscriber households were contacted, which resulted in 16,449 enrollments and 12,184 randomizations. Other methods of recruitment yielded 1421 enrollments and 1002 randomizations. Seventy-four % of those participants who enrolled in the 3-month placebo run-in were randomized. The major reasons for nonrandomization once subjects were enrolled were becoming ineligible (13%), concern about or development of side effects attributed to the study vitamins (18%), loss of interest or being too busy (23%), and not showing up at the appointed time or not willing to come to the study center (23%). Here, we discuss the reasons for nonparticipation and for subjects leaving the trial prior to randomization and possible modifications of trial design and procedures to address these problems. This recruitment approach provided a constant flow of potentially eligible participants, screened out many ineligible and uninterested persons prior to the scheduling of a study center visit, and ensured randomization of committed participants. A major limitation of this study was that the pool of minorities that was reached was small.
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Collection:
01-internacional
Database:
MEDLINE
Main subject:
Smoking
/
Patient Selection
/
Lung Neoplasms
Type of study:
Clinical_trials
/
Incidence_studies
/
Prognostic_studies
Limits:
Aged
/
Female
/
Humans
/
Male
/
Middle aged
Country/Region as subject:
America do norte
Language:
En
Journal:
Cancer Epidemiol Biomarkers Prev
Journal subject:
BIOQUIMICA
/
EPIDEMIOLOGIA
/
NEOPLASIAS
Year:
1998
Document type:
Article
Affiliation country:
United States