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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.

Wolvers MDj, Bruggeman-Everts FZ, Van der Lee ML, Van de Schoot R, Vollenbroek-Hutten MM - JMIR Res Protoc (2015)

Bottom Line: 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.Recruitment started in April 2013 and will proceed until April 2015.

View Article: PubMed Central - HTML - PubMed

Affiliation: Roessingh Research and Development, Telemedicine Group, Enschede, Netherlands. m.wolvers@rrd.nl.

ABSTRACT

Background: Internet 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.

Objective: This 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.

Methods: A 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.

Results: Recruitment started in April 2013 and will proceed until April 2015.

Conclusions: This 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 registration: The Netherlands National Trial Register (NTR3483). (Archived by WebCite at http://www.webcitation.org/6NWZqon3o).

No MeSH data available.


Related in: MedlinePlus

Screenshot of the Web portal for eMBCT (Dutch).
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figure2: Screenshot of the Web portal for eMBCT (Dutch).

Mentions: Mindfulness-based cognitive therapy (MBCT) [37] adds elements of cognitive therapy to the mindfulness-based stress reduction program that was originally developed by John Kabat-Zinn [38]. The Helen Dowling Institute (Bilthoven, the Netherlands) developed a 9-week Web-based, therapist-guided, individual MBCT (eMBCT) specifically designed to reduce cancer-related fatigue [23]. On a personal Web page (see Figure 2 and Multimedia Appendix 3), each patient can download audio files of mindfulness exercises and read information about a specific mindfulness theme each week. Patients write down their experiences of following the mindfulness exercises in a log. On an agreed-upon day of the week, the therapist replies to this log, thereby guiding the patient through the program. It is hypothesized that by learning to raise awareness of their present experience nonjudgmentally and openly, the patient can become aware of potentially ineffective coping strategies that prolong stress and fatigue [39,40]. Patients learn to use a detached perspective as a skill to prevent the escalation of automatic negative thinking patterns. MBCT also teaches patients how to accept fatigue, physical limitations, or pain. The protocol of the eMBCT is discussed more extensively in the article by Bruggeman-Everts et al [34].


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.

Wolvers MDj, Bruggeman-Everts FZ, Van der Lee ML, Van de Schoot R, Vollenbroek-Hutten MM - JMIR Res Protoc (2015)

Screenshot of the Web portal for eMBCT (Dutch).
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4526958&req=5

figure2: Screenshot of the Web portal for eMBCT (Dutch).
Mentions: Mindfulness-based cognitive therapy (MBCT) [37] adds elements of cognitive therapy to the mindfulness-based stress reduction program that was originally developed by John Kabat-Zinn [38]. The Helen Dowling Institute (Bilthoven, the Netherlands) developed a 9-week Web-based, therapist-guided, individual MBCT (eMBCT) specifically designed to reduce cancer-related fatigue [23]. On a personal Web page (see Figure 2 and Multimedia Appendix 3), each patient can download audio files of mindfulness exercises and read information about a specific mindfulness theme each week. Patients write down their experiences of following the mindfulness exercises in a log. On an agreed-upon day of the week, the therapist replies to this log, thereby guiding the patient through the program. It is hypothesized that by learning to raise awareness of their present experience nonjudgmentally and openly, the patient can become aware of potentially ineffective coping strategies that prolong stress and fatigue [39,40]. Patients learn to use a detached perspective as a skill to prevent the escalation of automatic negative thinking patterns. MBCT also teaches patients how to accept fatigue, physical limitations, or pain. The protocol of the eMBCT is discussed more extensively in the article by Bruggeman-Everts et al [34].

Bottom Line: 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.Recruitment started in April 2013 and will proceed until April 2015.

View Article: PubMed Central - HTML - PubMed

Affiliation: Roessingh Research and Development, Telemedicine Group, Enschede, Netherlands. m.wolvers@rrd.nl.

ABSTRACT

Background: Internet 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.

Objective: This 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.

Methods: A 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.

Results: Recruitment started in April 2013 and will proceed until April 2015.

Conclusions: This 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 registration: The Netherlands National Trial Register (NTR3483). (Archived by WebCite at http://www.webcitation.org/6NWZqon3o).

No MeSH data available.


Related in: MedlinePlus