Considerations of Control Conditions Designs in Randomized Controlled Trials of Exercise Interventions for Cancer Survivors

Abstract

Background: Given the multifaceted complexity in the nature of randomized controlled trials, identifying an appropriate and comparable control condition is an essential step to ensure methodological rigor, which allows for researchers to draw unambiguous conclusions concerning the efficacy of the intervention being studied.

Objectives: The objectives of this paper are to (a) review the current literature and analyze the control condition designs in exercise interventions targeted for cancer survivors; (b) provide an overview of the benefits and limitations of various types of control conditions used in exercise interventions; (c) discuss the considerations in the design of control conditions for exercise interventions; and (d) suggest recommendations for control condition design in future trials of behavioral interventions.

Results: The review of randomized controlled trials of exercise training interventions for cancer survivors revealed that the design of control conditions varied. The most commonly employed design could be classified into two major categories: (a) active controls including attention control, add-on controls, and dismantling controls; and (b) inactive controls including no-treatment, usual care, and wait-list control. Examples from the literature are presented. Four principal considerations concerning control condition design, including appropriateness, credibility, appeal, and comparability, are discussed. Recommendations on how to avoid some major threats to validity and potential biases are also provided.

Conclusions: Careful planning for the control group design is as important as for the intervention group. Researchers can use the considerations presented in the paper to assist in planning for the most appropriate control condition for their study.

Keywords: control conditions; exercise interventions; methodology; randomized controlled trials; study design.