Qualitative research contribution to a randomized clinical trial.

Qualitative research may be combined fruitfully with intervention studies, but few examples provide detailed methodological strategies for doing so. In this article, we describe the qualitative component of a randomized clinical trial (RCT) of the PRO-SELF(c) Pain Control Program, an intervention that provides individualized education, coaching, and support for cancer pain management. We conducted three qualitative analyses of verbatim transcripts of "real-time" audiotaped intervention sessions. As a result, we were better able to ascertain the nature of the individualized coaching component of the intervention, patient and family caregiver use of selected intervention tools, and reasons the intervention did not work for some patients. Study results were used to increase the specificity with which the coaching portion of the intervention is described in the intervention protocol. (c) 2005 Wiley Periodicals, Inc.