Using the Rehabilitation Treatment Specification System to Describe Experimental and Control Arms of a Clinical Trial for Breast Cancer Survivors

Abstract

The Rehabilitation Treatment Specification System (RTSS) provides a framework to decompose complex interventions into components, each defined by its known or hypothesized active ingredients. In addition to its value in planning new interventions and understanding existing ones, we suggest it can be used to help interpret findings of clinical trials and plan next steps in a research program. This paper presents an analysis in which we used the RTSS to retrospectively delineate targets and ingredients of an experimental treatment, Behavioral Activation and Problem-Solving (BA/PS), and then examined the attention control condition for overlapping ingredients that could clarify the control condition's unanticipated effects. Our BA/PS intervention had seven treatment components; three were unique to the BA/PS condition, but the attention control condition contained ingredients that mirrored those found in four of the BA/PS components. Our results illuminate the challenges of designing an adequate control condition for behavioral rehabilitation trials among survivors of cancer. This RTSS application was instrumental in refining our conceptual model and preparing for future research. It serves as a model for other cancer rehabilitation researchers, emphasizing the importance of intentional and transparent intervention specification to advance the field.

Keywords: Placebo effect; neoplasms; therapeutic alliance.