Effectiveness, Mediators, and Effect Predictors of Internet Interventions for Chronic Cancer-Related Fatigue: The Design and an Analysis Plan of a 3-Armed Randomized Controlled Trial

Abstract

BackgroundInternet interventions offer advantages that especially cancer survivors who suffer from fatigue could benefit from. Given the growing number of such patients, Internet interventions could supplement and strengthen currently available health care.ObjectiveThis paper describes the design and analysis plan that will be used to study 2 Internet interventions aimed at reducing severe fatigue in cancer survivors: a mobile ambulant activity feedback therapy supported through a weekly email by a physiotherapist and a weekly Web- and mindfulness-based cognitive therapy supported online by a psychologist. The data resulting from this trial will be used to (1) investigate the effectiveness, (2) investigate potential mediators of these interventions, and (3) explore participant characteristics that can predict the effect of these interventions.MethodsA 3-armed randomized controlled trial is proposed that compares both Internet interventions with an active control condition that solely consists of receiving psycho-educational emails. The intervention period is 9 weeks for all 3 conditions. Six months after baseline, participants in the control condition can choose to follow 1 of the 2 experimental Internet interventions. Outcomes are measured in terms of fatigue severity, mental health, and self-perceived work ability. All are Web-assessed at baseline, 2 weeks after the intervention period, and at 6 and 12 months after baseline. Fatigue severity, mindfulness, physical activity, expectations and credibility of the intervention, therapeutic working alliance, sleep quality, and sense of control over fatigue are assessed 3 times during the intervention period for identifying mediators of the interventions. Recruitment is performed nationally throughout the Netherlands through patient organizations and their websites, newspapers, and by informing various types of health professionals. All participants register at an open-access website. We aim at including 330 cancer survivors who have finished curative-intent cancer treatment at least 3 months previously, and have been suffering from severe fatigue ever since. All cancer types are included. A detailed analysis plan is described to address the research questions, which allows for individual variation, and fully exploits the longitudinal design.ResultsRecruitment started in April 2013 and will proceed until April 2015.ConclusionsThis paper describes a systematic trial design for studying 2 different interventions for chronic cancer-related fatigue in order to gain insight into the effectiveness and mediators of the interventions. This design will also be used to identify predictors for the interventions’ effect on fatigue. By publishing our hypotheses and analysis plan before completion of data collection, this paper is a first step in reporting on this trial comprehensively.Trial RegistrationThe Netherlands National Trial Register (NTR3483). (Archived by WebCite at http://www.webcitation.org/6NWZqon3o).

The efficacy of Internet‐based cognitive behavioral therapy for severely fatigued survivors of breast cancer compared with care as usual: A randomized controlled trial

“…7 This intervention currently is being tested in an RCT, but to our knowledge the results have not been published to date. 8 Another relevant, ongoing RCT concerns a pilot study by Corbett et al examining an online selfmanagement intervention with CBT elements. 9 Finally, 2 RCTs by Willems et al 10 and van den Berg et al 11 demonstrated that a general Web-based self-management intervention for psychosocial adjustment in cancer survivors (without a specific focus on fatigue) led to improvements in fatigue compared with a nonactive control group, with small effect sizes (Cohen's d of 0.2 and 0.3, respectively).…”

“…A randomized controlled trial (RCT) by Yun et al 5 demonstrated that a Web-based self-management education program led to greater improvements in fatigue in cancer survivors compared with care as usual (CAU). 8 Another relevant, ongoing RCT concerns a pilot study by Corbett et al examining an online selfmanagement intervention with CBT elements. However, this effect was not sustained at a follow-up of 12 weeks, and no positive effect on fatigue severity was found.…”

Wearable activity monitors in oncology trials: Current use of an emerging technology

“…Published protocols of clinical trials [74][75][76][77][78][79][80][81] involving wearable activity monitors in cancer populations are listed in Supplementary Table 2. The most commonly reported device among protocols is the triaxial GT3X + accelerometer (n = 3) [76,79,81].…”

“…The most commonly reported device among protocols is the triaxial GT3X + accelerometer (n = 3) [76,79,81]. Other trial designs include the use multisensor systems paired with smart phone applications (n = 2) [79,80], pedometers/step counters (n = 2) [74,77], and other accelerometers (n = 2) [75,78], and two trials plan to use more than one device [77,79].…”

Mobile Technology to Monitor Physical Activity and Wellbeing in Daily Life - Objective and Subjective Experiences of Older Adults

“…Feedback on physical activity was provided on the device itself, and also on the screen of the mobile phone, using the Activity Coach application. This application is a re-design of the application developed by Roessingh Research and Development and tested with several clinical populations, such as cancer survivors (Wolvers et al 2015) and patients suffering from chronic pulmonary obstructive disease (Tabak et al 2014). In the mobile phone, participants received feedback on the number of steps at that moment, number of steps at the current day per hour and during the last week per day.…”