141st APHA Annual Meeting

In This section

Nursing interventions: Maximizing enrollment and retention in community-based randomized clinical trials

Monday, November 4, 2013 : 4:30 PM - 4:50 PM

Cheryl L. Cox, RN, PhD , Epidemiology, Cancer Prevention and Control, St. Jude Children's Research Hospital, Memphis, TN
Deborah Sherrill-Mittleman, PhD , Epidemiology, Cancer Prevention and Control, St. Jude Children's Research Hospital, Memphis, TN
Linda Barnes, RN, CRA , Epidemiology, Cancer Prevention and Control, St. Jude Children's Research Hospital, Memphis, TN
Anne Christie, MSc, CCRP , Child Health Evaluative Services, Toronto SIck Children's Hospital, Toronto, ON, Canada
Kristin Vangile, MPH, CCRP , Clinical Research Office, Aflac Cancer and Blood Disorders Center, Children's Healthcare of Atlanta, Atlanta, GA
Background: As nurse investigators increasingly conduct randomized clinical trials (RCTs) to demonstrate the impact of prevention-based interventions, they may experience enrollment well below that seen in therapeutic trials. Here we describe the challenges to enrollment and retention of children and their families on a community-based 2.5-year RCT.

Methods: At 4 pediatric cancer centers, children with acute lymphoblastic leukemia (ages 4 -18.9 years) and their parents/guardians were invited to participate in an RCT to test a motivation-based physical activity intervention focused on prevention of treatment-related effects. The intervention, which targeted improved physical function, quality of life, and bone mineral density, began within 10 days of the start of treatment and continued until the end of therapy. Patient disposition (ineligible, declined (reasons for declining), enrolled, withdrew (reasons for withdrawal) and contacting study personnel were tracked in a centralized database.

Results: The study's accrual goal (n=76) was met by extending the accrual timeline by 8 months. Of the 211 eligible patients, 89 (42%) patients/families declined to participate and 15 (7%) withdrew after giving informed consent but before the baseline assessment; 29 (14%) families withdrew after the intervention had begun. Study enrollment varied by study personnel who contacted the families (p=0.02, Fisher's exact test). The retention rate, excluding withdrawals for medical reasons, was 33%100% across study sites.

Conclusion: Patient/family factors, changing community demographics, and study personnel influenced enrollment and retention in a community-based RCT. These factors can be proactively addressed in study design and in disclosure of study information to maximize participation.

Learning Areas:
Conduct evaluation related to programs, research, and other areas of practice
Public health or related nursing
Public health or related research

Learning Objectives:
Identify barriers to enrollment and retention in community-based randomized clinical trials. Describe how knowledge of these barriers can inform study design and improve how study information is disclosed and understood. Formulate specific strategies to proactively maximize enrollment and retention in community-based randomized clinical trials.

Keywords: Clinical Trials, Research

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I have been the principal investigator on mutliple federally funded grants focusing on health promotion and disease prevention in the general population and in adult survivors of childhood cancer. My interests have included the development of instrumentation and intervention strategies to measure and support motivation for health promotion activities. I am currently conducting two randomized controlled clinical trials targeting health promotion in childhood cancer survivors.
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.