Effectiveness of Two Web-Based Interventions for Chronic Cancer-Related Fatigue Compared to an Active Control Condition: Results of the “Fitter na kanker” Randomized Controlled Trial

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Abstract

Background

Approximately one third of all patients who have been successfully treated for cancer suffer from chronic cancer-related fatigue (CCRF). Effective and easily accessible interventions are needed for these patients.

Objective

The current paper reports on the results of a 3-armed randomized controlled trial investigating the clinical effectiveness of two different guided Web-based interventions for reducing CCRF compared to an active control condition.

Methods

Severely fatigued cancer survivors were recruited via online and offline channels, and self-registered on an open-access website. After eligibility checks, 167 participants were randomized via an embedded automated randomization function into: (1) physiotherapist-guided Ambulant Activity Feedback (AAF) therapy encompassing the use of an accelerometer (n=62); (2) psychologist-guided Web-based mindfulness-based cognitive therapy (eMBCT; n=55); or (3) an unguided active control condition receiving psycho-educational emails (n=50). All interventions lasted nine weeks. Fatigue severity was self-assessed using the Checklist Individual Strength - Fatigue Severity subscale (primary outcome) six times from baseline (T0b) to six months (T2). Mental health was self-assessed three times using the Hospital Anxiety and Depression Scale and Positive and Negative Affect Schedule (secondary outcome). Treatment dropout was investigated.

Results

Multiple group latent growth curve analysis, corrected for individual time between assessments, showed that fatigue severity decreased significantly more in the AAF and eMBCT groups compared to the psycho-educational group. The analyses were checked by a researcher who was blind to allocation. Clinically relevant changes in fatigue severity were observed in 66% (41/62) of patients in AAF, 49% (27/55) of patients in eMBCT, and 12% (6/50) of patients in psycho-education. Dropout was 18% (11/62) in AAF, mainly due to technical problems and poor usability of the accelerometer, and 38% (21/55) in eMBCT, mainly due to the perceived high intensity of the program.

Conclusions

Both the AAF and eMBCT interventions are effective for managing fatigue severity compared to receiving psycho-educational emails.

Trial Registration

Trialregister.nl NTR3483; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3483 (Archived by WebCite at http://www.webcitation.org/6NWZqon3o)

Related collections

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Is Open Access

Making trials matter: pragmatic and explanatory trials and the problem of applicability

Shaun Treweek, Merrick Zwarenstein (2009)

Randomised controlled trials are the best research design for decisions about the effect of different interventions but randomisation does not, of itself, promote the applicability of a trial's results to situations other than the precise one in which the trial was done. While methodologists and trialists have rightly paid great attention to internal validity, much less has been given to applicability. This narrative review is aimed at those planning to conduct trials, and those aiming to use the information in them. It is intended to help the former group make their trials more widely useful and to help the latter group make more informed decisions about the wider use of existing trials. We review the differences between the design of most randomised trials (which have an explanatory attitude) and the design of trials more able to inform decision making (which have a pragmatic attitude) and discuss approaches used to assert applicability of trial results. If we want evidence from trials to be used in clinical practice and policy, trialists should make every effort to make their trial widely applicable, which means that more trials should be pragmatic in attitude.

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Author and article information

Contributors

Fieke Z Bruggeman-Everts:

Helen Dowling InstituutScientific Research DepartmentProfessor Bronkhorstlaan 20Bilthoven, 3723 MBNetherlands31 30 252 40 2031 30 252 40 22bruggeman.everts@gmail.com

ORCID: http://orcid.org/0000-0001-8115-2863

Journal

Journal ID (nlm-ta): J Med Internet Res

Journal ID (iso-abbrev): J. Med. Internet Res

Journal ID (publisher-id): JMIR

Title: Journal of Medical Internet Research

Publisher: JMIR Publications (Toronto, Canada )

ISSN (Print): 1439-4456

ISSN (Electronic): 1438-8871

Publication date Collection: October 2017

Publication date (Electronic): 19 October 2017

Volume: 19

Issue: 10

Electronic Location Identifier: e336

Affiliations

[1] ¹ Helen Dowling Instituut Scientific Research Department Bilthoven Netherlands

[2] ² Telemedicine Group Faculty of Electrical Engineering, Mathematics, and Computer Science University of Twente Enschede Netherlands

[3] ³ Roessingh Research and Development Telemedicine Group Enschede Netherlands

[4] ⁴ Telemedicine Group Faculty of Electrical Engineering Mathematics and Computer Science University of Twente Enschede Netherlands

[5] ⁵ Department of Methods and Statistics Utrecht University Utrecht Netherlands

[6] ⁶ North-West University Vanderbijlpark South Africa

Author notes

Corresponding Author: Fieke Z. Bruggeman-Everts bruggeman.everts@ 123456gmail.com

Author information

Fieke Z Bruggeman-Everts http://orcid.org/0000-0001-8115-2863

Marije D J Wolvers http://orcid.org/0000-0001-5833-9232

Rens van de Schoot http://orcid.org/0000-0001-7736-2091

Miriam M R Vollenbroek-Hutten http://orcid.org/0000-0002-8372-3022

Marije L Van der Lee http://orcid.org/0000-0002-1316-7008

Article

Publisher ID: v19i10e336

DOI: 10.2196/jmir.7180

PMC ID: 5668634

PubMed ID: 29051138

SO-VID: 6e1f4685-3ec8-4b25-9deb-fd72397b33b7

Copyright © ©Fieke Z. Bruggeman-Everts, Marije D. J. Wolvers, Rens van de Schoot, Miriam M. R. Vollenbroek-Hutten, Marije L. Van der Lee. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 19.10.2017.

License:

This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research, is properly cited. The complete bibliographic information, a link to the original publication on http://www.jmir.org/, as well as this copyright and license information must be included.

History

Date received : 21 December 2016

Date revision requested : 9 February 2017

Date revision received : 5 May 2017

Date accepted : 6 July 2017

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