Beating Cancer-Related Fatigue With the Untire Mobile App:Protocol for a Waiting List Randomized Controlled Trial

Background: Many cancer patients and survivors worldwide experience disabling fatigue as the main side effect of their illness and the treatments involved. Face-to-face therapy is effective in treating cancer-related fatigue (CRF), but it is also resource-intensive. Offering a self-management program via a mobile phone app (ie, the Untire app), based on elements of effective face-to-face treatments, might increase the number of patients receiving adequate support for fatigue and decrease care costs. Objective: The aim of this protocol is to describe a randomized controlled trial (RCT) to assess the effectiveness of the Untire app in reducing fatigue in cancer patients and survivors after 12 weeks of app use as compared with a waiting list control group. Substudies nested within this trial include questions concerning the reach and costs of online recruitment and uptake and usage of the Untire app. Methods: The Untire app study is a waiting list RCT targeting cancer patients and survivors who experience moderate to severe fatigue via social media (Facebook and Instagram) across 4 English-speaking countries (Australia, Canada, the United Kingdom, and the United States). The Untire app includes psychoeducation and exercises concerning energy conservation, activity management, optimizing restful sleep, mindfulness-based stress reduction, psychosocial support, cognitive behavioral therapy, and physical activity. After randomization, participants in the intervention group could access the Untire app immediately, whereas control participants had no access to the Untire app until the primary follow-up assessment at 12 weeks. Participants completed questionnaires at baseline before randomization and after 4, 8, 12, and 24 weeks. The study outcomes are fatigue (primary) and quality of life (QoL; secondary). Potential moderators and mediators of the hypothesized treatment effect on levels of fatigue and QoL were also assessed. Link clicks and app activation are used to assess reach and uptake, respectively. Log data are used to explore the characteristics of app use. Sample size calculations for the primary outcome showed that we needed to include 164 participants with complete 12-week measures both in the intervention and the control groups. The intention-to-treat approach is used in the primary analyses, which refers to analyzing all participants regardless of their app use. Results: Participants were recruited from March to October 2018. The last participant completed the 24-week assessment in March 2019. Conclusions: This mobile health (mHealth) RCT recruited participants online in multiple countries to examine the uptake and effectiveness of the Untire self-management app to reduce CRF. Many advantages of mHealth apps are assumed, such as the immediate access to the app, the low thresholds to seek support, and the absence of contact with care professionals that will reduce costs. If found effective, this app can easily be offered worldwide to patients experiencing CRF

Recruiting participants for an international mHealth study via Facebook Ads:Experiences from the Untire App RCT

Introduction: Social media recruitment via Facebook Ads seems to be a promising method for large-scale international trials examining the effectiveness of mHealth interventions. However, little is known about this method in terms of strategy, reach, and costs in the context of psycho-oncology. This paper presents the results of the recruitment strategy that was applied in the Untire app study and shows how many participants could be reached using advertisements (i.e., Ads) on Facebook, who participated, and what it cost. Method: The Untire app study is a randomized controlled trial targeted at cancer patients and survivors across four English-speaking countries (i.e., Australia, Canada, the U.K., and the U.S.A.). Reach was assessed by the number of people who were shown the Ads, who clicked on the Ads, and completed study assessments. Demographic characteristics were gathered from Facebook Ads Manager and from online study assessments to describe who was reached. Costs were assessed by the budget spent and the cost per click for Ads, for reaching the study's landing page, and for completing study assessments. To conduct a powered RCT, we needed 164 12-weeks assessments in both the intervention and the control group. Results: From March till October 2018, we used 76 Ads, which were presented to 1.2 million people. 37.376 persons clicked on the study link in the Ads, resulting in 755 baseline completers. Most participants were female (92%), middle-aged (55.5 ± 9.79), and came from the U.K. (72%). The total Facebook advertisement costs from March till October 2018 were €17 k, resulting in an average cost of €0.45 per click on the Ads, €5.55 on average for a person reaching the study's landing page, and €14.89 on average per eligible participant. The costs for every baseline and 12-weeks completer were €22.42 and €47.69, respectively. Discussion: Reaching participants for international mHealth studies in psycho-oncology via Facebook Ads has potential but is costly. The key to reducing costs lies in constant optimization and testing of Ads and refinement of target audience characteristics

Ethical review procedures in international internet-based intervention studies

International internet-based studies could be accessible by participants from various countries worldwide. However, the jurisdiction of research ethics committees (RECs) or institutional review boards (IRBs) is bound to geographical state or country borders. How can researchers deal with the geographical boundaries in the jurisdiction of RECs/IRBs versus the worldwide, open character of international internet-based research? Should ethical approval be sought in each country where participants will be recruited? In this paper, we want to share our challenges in setting up the ethical review procedures in an international internet-based mHealth intervention study, to further the discussion on ethical procedures in internet-based research