Recruitment challenges in clinical research including cancer patients and their caregivers. A randomized controlled trial study and lessons learned

Trials. 2015 Sep 25;16:428. doi: 10.1186/s13063-015-0948-y.


Background: To test seven different strategies for recruitment in a randomized controlled trial, to report documented response data from each strategy, and to discuss recruitment challenges.

Methods: We used 5 opt-in (potential participants have to do something active to contact or be contacted by the researcher) and 2 opt-out (potential participants have the option to decline being contacted about a study) recruitment strategies from February 2013 until July 2014 to contact 1562 cancer patient candidates for participation in a randomized controlled trial. For each of these cancer patients a caregiver was also invited to take part in the study.

Results: Of the 1562 candidates, 22.6 % were ineligible on initial contact, 56.7 % declined to participate on initial contact, and 8.9 % agreed orally to participate but did not complete the enrollment. The 2 opt-out strategies, on-site recruitment and routine care letters recruitment, yielded the highest number of recruited participants with 79 dyads and 58 dyads respectively, constituting 42.7 % and 31.4 % of the total number of enrolled candidates. The 5 opt-in recruitment approaches yielded 49 dyads for the study. Almost half of these dyads were recruited using the approach termed "relying on providers at the hospital."

Conclusions: In this study, opt-out recruitment strategies appeared to be the most effective.

Trial registration: Registration number NCT01867723 , registered February 2012.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Advertising / methods*
  • Caregivers / psychology*
  • Choice Behavior*
  • Correspondence as Topic
  • Eligibility Determination
  • Health Knowledge, Attitudes, Practice*
  • Humans
  • Information Dissemination
  • Mass Media
  • Neoplasms / diagnosis
  • Neoplasms / psychology
  • Neoplasms / therapy*
  • Norway
  • Pamphlets
  • Patient Acceptance of Health Care*
  • Patient Selection*
  • Research Subjects / psychology*
  • Sample Size
  • Social Media

Associated data