Clinical trials and tribulations: lessons learned from recruiting pregnant ex-smokers for relapse prevention.

Elena N Lopez, Vani Nath Simmons, Gwendolyn P Quinn, Cathy D Meade, Thomas N Chirikos, Thomas H Brandon
Author Information
  1. Elena N Lopez: Department of Psychology, University of South Florida, and the H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL 33617, USA.

Abstract

The development of smoking cessation and relapse prevention interventions for pregnant and postpartum women is a public health priority. However, researchers have consistently reported substantial difficulty in recruiting this population into clinical trials. The problem is particularly acute for relapse prevention studies, which must recruit women who have already quit smoking because of their pregnancy. Although these individuals are an important target for tobacco control efforts, they represent an extremely small subgroup of the general population. This paper describes multiple recruitment strategies used for a clinical trial of a self-help relapse prevention program for pregnant women. The effectiveness of the strategies and the direct expense per participant recruited are provided. A proactive recruitment strategy (telephoning women whose phone numbers were purchased from a marketing firm) was ultimately much more successful than a variety of reactive strategies (advertisements, press releases, direct mail, Web placement, health care provider outreach). We found few differences between proactively and reactively recruited participants on baseline variables. The primary difference was that the former had smoked fewer cigarettes per day and reported lower nicotine dependence prior to quitting. Strengths and limitations of the recruitment strategies are discussed.

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Grants

  1. R01 CA094256/NCI NIH HHS
  2. CA94256/NCI NIH HHS

MeSH Term

Adult
Clinical Trials as Topic
Female
Humans
Patient Education as Topic
Patient Selection
Personnel Selection
Pregnancy
Pregnancy Complications
Pregnant People
Prenatal Care
Research Design
Risk Reduction Behavior
Secondary Prevention
Smoking
Smoking Cessation
Smoking Prevention

Word Cloud

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