Integrative Oncology Trials in the Real World: Assessing the Pragmatism of an Ongoing Integrative Oncology Trial of Mindfulness and T'ai Chi/Qigong.
Linda E. Carlson, Devesh Oberoi, Maryam Qureshi, Utkarsh Subnis
The Journal of Alternative and Complementary Medicine September 1, 2018 DOI: 10.1089/acm.2018.0208 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Methodological assessment (application of PRECIS-2 criteria to a trial protocol) Randomized Peer reviewed |
|---|---|
| Sample size | 600 |
| Population | Cancer survivors who have completed all cancer treatments and are distressed, recruited at tertiary care cancer centers in Calgary and Toronto, Canada |
| Interventions | Mindfulness-based cancer recovery (MBCR) T'ai chi/qigong (TCQ) |
| Topics | Meditation |
| Keywords | Humans Neoplasms Tai ji Adult Canada Female Qigong Cancer survivors Integrative oncology Rct Explanatory trials Pragmatic trials Precis-2 |
| Key findings | Applied to the MATCH trial, the nine PRECIS-2 domains rated the trial as more explanatory than pragmatic, despite initial design efforts toward pragmatism. Recruitment, follow-up, and intervention delivery were the least pragmatic domains, while setting, outcomes, and data analysis were the more pragmatic ones. The authors argue that more pragmatic trials are needed in integrative oncology and that PRECIS-2 can guide researchers during trial planning. |
Abstract
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.
Comparable studies
Other non-randomized and open-label trials on meditation, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Mindfulness-Based Stress Reduction in Relation to Quality of Life, Mood, Symptoms of Stress, and Immune Parameters in Breast and Prostate Cancer Outpatients Early-stage breast and prostate cancer patients | 2003 | Pre-post intervention study | n = 59 |
| Exploring self‐compassion and empathy in the context of mindfulness‐based stress reduction (MBSR) Community sample | 2010 | Pre-post intervention study | |
| Mindfulness-Based Stress Reduction Lowers Psychological Distress In Medical Students Second-year medical students | 2003 | Prospective nonrandomized cohort-controlled study | n = 302 |
| Intensive meditation training, immune cell telomerase activity, and psychological mediators. Retreat participants and matched controls | 2011 | Controlled trial with wait-list control group | n = 60 |
| The Effectiveness of Mindfulness Training for Children with ADHD and Mindful Parenting for their Parents Children aged 8-12 with ADHD and their parents | 2011 | Within-group waitlist controlled trial | n = 22 |