The ZENERGISE single-arm trial aims to test feasibility of a 12-week program of combined group mindfulness and exercise intervention in cancer survivors experiencing post-treatment fatigue. It is delivered face-to-face (F2F) by healthcare professionals at Sydney Cancer Survivorship Centre (SCSC), NSW. In March 2020, (Week 4 of second program), COVID-19 was declared a national biosecurity emergency. Here, we chronicle the steps taken to continue the trial while navigating participant safety and scientific integrity.
A timeline of changes unfolding from February - June 2020 will be presented. Principles of discussions with Research Governance & Scientific Advisory committees and SCSC team members will be summarised. We developed an online version of the program with ‘COVID-19 safe’ protocol amendments. We incorporated a COVID-19 substudy into existing post-intervention questionnaires to understand participant experience. Baseline and post-intervention PROMs including FACT-F and FSI fatigue subscales were collected.
Five patients consented to participate in the 2nd program commencing February 2020. Two withdrew in Week 4 (early stages of the pandemic) and the trial was temporarily suspended in Week 5 in anticipation of further restrictions. Following ‘COVID-19-safe’ protocol amendments, we resumed and completed the 12-week online ZENERGISE program with three remaining participants by June. All participants went from baseline moderate fatigue to “not at all fatigued” on relevant post-treatment fatigue subscales. Participants did not find the online program challenging “at all” and agreed/completely agreed that health outcomes would be equally favourable from the online vs F2F program.
The ZENERGISE trial of combined mindfulness and exercise for cancer survivors successfully adapted and was widely accepted during the first NSW COVID-19 pandemic wave. Extensive support facilitated prompt switch to online delivery of important lifestyle components to cancer survivors at further risk of fragmented care and social isolation. Recruitment for a third ‘hybrid F2F/online’ intervention is now underway.