Results of the Optimune trial: A randomized controlled trial evaluating a novel Internet intervention for breast cancer survivors

Franziska Holtdirk, Anja Mehnert, Mario Weiss, Johannes Mayer, Björn Meyer, Peter Bröde, Maren Claus, Carsten Watzl, Franziska Holtdirk, Anja Mehnert, Mario Weiss, Johannes Mayer, Björn Meyer, Peter Bröde, Maren Claus, Carsten Watzl

Abstract

Introduction: After the acute treatment phase, breast cancer patients often experience low quality of life and impaired mental health, which could potentially be improved by offering cognitive behavioural therapy (CBT) and addressing exercise and dietary habits. However, CBT and other behavioural interventions are rarely available beyond the acute treatment phase. Internet-based interventions could bridge such treatment gaps, given their flexibility and scalability. In this randomized controlled trial (RCT), we investigated the effects of such an intervention ("Optimune") over three months.

Methods: This RCT included 363 female breast cancer survivors (age range = 30-70), recruited from the community, who had completed the active treatment phase. Inclusion criteria were: breast cancer diagnosis less than 5 years ago and acute treatment completion at least 1 month ago. Participants were randomly assigned to (1) an intervention group (n = 181), in which they received care as usual (CAU) plus 12-month access to Optimune immediately after randomization, or (2) a control group (n = 182), in which they received CAU and Optimune after a delay of 3 months. Primary endpoints were quality of life (QoL), physical activity, and dietary habits at three months. We hypothesized that intervention group participants would report better QoL, more physical activity, and improved dietary habits after 3 months.

Results: Intention-to-treat (ITT) analyses revealed significant effects on QoL (d = 0.27, 95% CI: 0.07-0.48) and dietary habits (d = 0.36, 95% CI: 0.15-0.56), but the effect on physical exercise was not significant (d = 0.30; 95% CI: 0.10-0.51).

Discussion: These findings suggest the effectiveness of Optimune, a new CBT-based Internet intervention for breast cancer survivors, in facilitating improvements in quality of life and dietary habits. Efforts to disseminate this intervention more broadly may be warranted.

Trial registration: ClinicalTrials.gov, NCT03643640. Registered August 23rd 2018, https://ichgcp.net/clinical-trials-registry/NCT03643640.

Conflict of interest statement

F. H., M.W., B.M., and J.M. are affiliated with Gaia, the company that funded this trial and that developed, owns, and operates the Internet intervention evaluated in it. B.M. is employed full‐time as Research Director, M.W. is Chief Executive Officer and founder of Gaia, and F.H. and J.M. are employed full‐time as research associates. This does not alter our adherence to PLOS ONE policies on sharing data and materials. None of the authors who are not employed by Gaia received any remuneration from Gaia.

Figures

Fig 1. Study flowchart.
Fig 1. Study flowchart.
Trial design and participant flow. TAU (Treatment as Usual), WL (waitlist).
Fig 2. Primary endpoints.
Fig 2. Primary endpoints.
Effects of Optimune on quality of life, dietary habits and physical exercise habits. Mean total scores (error bars represent SEM) are shown for each outcome measure before the intervention (T0, baseline) and at the end of the intervention (T1, 3 months). Treatment had significant effects on (A) quality of life and (C) dietary habits, whereas there was no effect on (B) physical exercise. MET (metabolic equivalent task, in minutes per week), IG (intervention group, n = 181), CG (control group, n = 182).

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