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

Fieke Zoë Everts, Marije D J Wolvers, Rens Van de Schoot, Miriam M R Vollenbroek-Hutten, Marije L Van der Lee

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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).
    Original languageEnglish
    Article numbere336
    Number of pages12
    JournalJournal of medical internet research
    Volume19
    Issue number10
    DOIs
    Publication statusPublished - 19 Oct 2017

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    Fatigue
    Randomized Controlled Trials
    Neoplasms
    Mindfulness
    Physical Therapists
    Cognitive Therapy
    Viperidae
    Random Allocation
    Checklist
    Survivors
    Appointments and Schedules
    Mental Health
    Anxiety
    Research Personnel
    Depression
    Psychology
    Education
    Therapeutics
    Growth

    Cite this

    @article{dba734df99e04243a5b610858e92cfa9,
    title = "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",
    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).",
    author = "Everts, {Fieke Zo{\"e}} and Wolvers, {Marije D J} and {Van de Schoot}, Rens and Vollenbroek-Hutten, {Miriam M R} and {Van der Lee}, {Marije L}",
    year = "2017",
    month = "10",
    day = "19",
    doi = "10.2196/jmir.7180",
    language = "English",
    volume = "19",
    journal = "Journal of medical internet research",
    issn = "1439-4456",
    publisher = "JMIR Publications",
    number = "10",

    }

    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. / Everts, Fieke Zoë; Wolvers, Marije D J; Van de Schoot, Rens; Vollenbroek-Hutten, Miriam M R; Van der Lee, Marije L.

    In: Journal of medical internet research, Vol. 19, No. 10, e336, 19.10.2017.

    Research output: Contribution to journalArticleAcademicpeer-review

    TY - JOUR

    T1 - Effectiveness of Two Web-Based Interventions for Chronic Cancer-Related Fatigue Compared to an Active Control Condition

    T2 - Results of the “Fitter na kanker” Randomized Controlled Trial

    AU - Everts, Fieke Zoë

    AU - Wolvers, Marije D J

    AU - Van de Schoot, Rens

    AU - Vollenbroek-Hutten, Miriam M R

    AU - Van der Lee, Marije L

    PY - 2017/10/19

    Y1 - 2017/10/19

    N2 - 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).

    AB - 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).

    U2 - 10.2196/jmir.7180

    DO - 10.2196/jmir.7180

    M3 - Article

    C2 - 29051138

    VL - 19

    JO - Journal of medical internet research

    JF - Journal of medical internet research

    SN - 1439-4456

    IS - 10

    M1 - e336

    ER -