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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

Flow chart of trial design. CS = cancer survivor; MD = medical doctor; PA = physical activity; T0(a-c)-T3 are the main assessments; Mi and Mi' represent assessments in week (i =) 1, 2, 3, 4, 6, and 9 of the intervention. For addressing the primary research questions of effectiveness, only data from the first semester will be used.
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figure3: Flow chart of trial design. CS = cancer survivor; MD = medical doctor; PA = physical activity; T0(a-c)-T3 are the main assessments; Mi and Mi' represent assessments in week (i =) 1, 2, 3, 4, 6, and 9 of the intervention. For addressing the primary research questions of effectiveness, only data from the first semester will be used.

Mentions: A randomized controlled trial is performed including 3 parallel conditions: 2 experimental conditions (AAF and eMBCT) and a minimal intervention control condition. The intervention period is 9 weeks for all 3 conditions. Both experimental conditions are made as similar as possible in terms of time-investment and contact intensity with the therapist. Outcomes are self-reported and are Web-assessed at baseline (T0), 2 weeks post-intervention (T1), and at 6 months (T2) and 12 months (T3) after baseline. Figure 3 shows a schematic summary of the trial design.


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)

Flow chart of trial design. CS = cancer survivor; MD = medical doctor; PA = physical activity; T0(a-c)-T3 are the main assessments; Mi and Mi' represent assessments in week (i =) 1, 2, 3, 4, 6, and 9 of the intervention. For addressing the primary research questions of effectiveness, only data from the first semester will be used.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

figure3: Flow chart of trial design. CS = cancer survivor; MD = medical doctor; PA = physical activity; T0(a-c)-T3 are the main assessments; Mi and Mi' represent assessments in week (i =) 1, 2, 3, 4, 6, and 9 of the intervention. For addressing the primary research questions of effectiveness, only data from the first semester will be used.
Mentions: A randomized controlled trial is performed including 3 parallel conditions: 2 experimental conditions (AAF and eMBCT) and a minimal intervention control condition. The intervention period is 9 weeks for all 3 conditions. Both experimental conditions are made as similar as possible in terms of time-investment and contact intensity with the therapist. Outcomes are self-reported and are Web-assessed at baseline (T0), 2 weeks post-intervention (T1), and at 6 months (T2) and 12 months (T3) after baseline. Figure 3 shows a schematic summary of the trial design.

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