Integrative Oncology Trials in the Real World: Assessing the Pragmatism of an Ongoing Integrative Oncology Trial of Mindfulness and T'ai Chi/Qigong.

OBJECTIVES: The aim of this study was to highlight features of pragmatic real-world integrative oncology research by applying the PRagmatic Explanatory Continuum Indicator Summary (PRECIS-2) criteria to an ongoing integrative oncology clinical trial. The ongoing trial is a preference-based randomized comparative effectiveness trial of mindfulness-based cancer recovery (MBCR) versus t'ai chi/qigong (TCQ) for cancer survivors (the Mindfulness and T'ai Chi for Cancer Health [MATCH] study). The primary outcome of the MATCH study is distress, and secondary outcomes are quality of life, sleep disturbance, and physical functioning. The clinical trial is being undertaken at tertiary care cancer centers across two sites in Canada: Calgary (AB) and Toronto (ON), with a sample of 600 cancer survivors who have finished all cancer treatments and are distressed.

METHODS AND RESULTS: The MATCH trial was scored on the explanatory-pragmatic continuum for each of the nine domains of the PRECIS-2 criteria on a scale of 1-5, and was rated as more explanatory than pragmatic, despite initial design efforts being more pragmatic. Areas that were least pragmatic were methods of recruitment, follow-up, and intervention delivery. The more pragmatic areas were setting, outcomes, and data analysis.

CONCLUSIONS: More efforts toward conducting pragmatic trials are needed in the field of integrative oncology, as cancer-care institutions and policy makers are looking for sustainable interventions within already established treatment models. The PRECIS-2 criteria can help researchers meet these goals in the planning stages of trial development.

KEYWORDS: PRECIS-2; RCT; explanatory trials; integrative oncology; pragmatic trials

PMID: 30247962 DOI: 10.1089/acm.2018.0208