Anja van der Hout1, Cornelia F van Uden-Kraan1, Karen Holtmaat1, Femke Jansen2, Birgit I Lissenberg-Witte3, Grard A P Nieuwenhuijzen4, José A Hardillo5, Robert J Baatenburg de Jong5, Nicolette L Tiren-Verbeet6, Dirkje W Sommeijer7, Koen de Heer8, Cees G Schaar9, Robert-Jan E Sedee10, Koop Bosscha11, Michiel W M van den Brekel12, Japke F Petersen12, Matthijs Westerman13, Jimmie Honings14, Robert P Takes14, Ilse Houtenbos15, Wim T van den Broek16, Remco de Bree17, Patricia Jansen18, Simone E J Eerenstein19, C René Leemans20, Josée M Zijlstra21, Pim Cuijpers22, Lonneke V van de Poll-Franse23, Irma M Verdonck-de Leeuw24. 1. Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, Netherlands; Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands. 2. Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, Netherlands; Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands; Department of Otolaryngology-Head and Neck Surgery, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands. 3. Department of Epidemiology and Biostatistics, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands. 4. Department of Surgery, Catharina Hospital, Eindhoven, Netherlands. 5. Department of Otolaryngology and Head and Neck Surgery, Rotterdam, Netherlands. 6. Department of Haematology, Erasmus Medical Centre, Rotterdam, Netherlands. 7. Department of Internal Medicine, Flevoziekenhuis, Almere, Netherlands; Department of Medical Oncology, University of Amsterdam, Amsterdam, Netherlands. 8. Department of Internal Medicine, Flevoziekenhuis, Almere, Netherlands; Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands. 9. Department of Internal Medicine, Gelre ziekenhuis, Apeldoorn, Netherlands. 10. Department of Otolaryngology, Head and Neck Surgery, Haaglanden MC, The Hague, Netherlands. 11. Department of Surgery, Jeroen Bosch Ziekenhuis, Den Bosch, Netherlands. 12. Department of Head and Neck Oncology and Surgery, Netherlands Cancer Institute, Amsterdam, Netherlands. 13. Department of Hematology, Northwest Clinics, Alkmaar, Netherlands. 14. Department of Otorhinolaryngology-Head and Neck Surgery, Radboud University Medical Center, Nijmegen, Netherlands. 15. Department of Hematology, Spaarne Gasthuis, Hoofddorp, Netherlands. 16. Department of Surgery, St Anna Hospital, Geldrop, Netherlands. 17. Department of Head and Neck Surgical Oncology, Utrecht University Medical Center, Utrecht, Netherlands. 18. Department of Surgery, Elisabeth-TweeSteden Hospital, Tilburg, Netherlands. 19. Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands; Department of Otolaryngology-Head and Neck Surgery, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands. 20. Department of Otolaryngology-Head and Neck Surgery, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands. 21. Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands; Department of Hematology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands. 22. Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, Netherlands. 23. Department of Research, Netherlands Comprehensive Cancer Organisation, Eindhoven, Netherlands; Division of Psychosocial Research and Epidemiology, Netherlands Cancer Institute, Netherlands; Center of Research on Psychological and Somatic Disorders, Department of Medical and Clinical Psychology, Tilburg University, Tilburg, Netherlands. 24. Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, Netherlands; Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands; Department of Otolaryngology-Head and Neck Surgery, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands. Electronic address: im.verdonck@amsterdamumc.nl.
Abstract
BACKGROUND: Knowledge about the efficacy of behavioural intervention technologies that can be used by cancer survivors independently from a health-care provider is scarce. We aimed to assess the efficacy, reach, and usage of Oncokompas, a web-based eHealth application that supports survivors in self-management by monitoring health-related quality of life (HRQOL) and cancer-generic and tumour-specific symptoms and obtaining tailored feedback with a personalised overview of supportive care options. METHODS: In this non-blinded, randomised, controlled trial, we recruited patients treated at 14 hospitals in the Netherlands for head and neck cancer, colorectal cancer, breast cancer, Hodgkin lymphoma, or non-Hodgkin lymphoma. Adult survivors (aged ≥18 years) were recruited through the Netherlands Cancer Registry (NCR) and invited by their treating physician through the Patient Reported Outcomes Following Initial Treatment and Long term Evaluation of Survivorship (PROFILES) registry. Participants were randomly assigned (1:1) by an independent researcher to the intervention group (access to Oncokompas) or control group (access to Oncokompas after 6 months), by use of block randomisation (block length of 68), stratified by tumour type. The primary outcome was patient activation (knowledge, skills, and confidence for self-management), assessed at baseline, post-intervention, and 3-month and 6-month follow-up. Linear mixed models (intention-to-treat) were used to assess group differences over time from baseline to 6-month follow-up. The trial is registered in the Netherlands Trial Register, NTR5774 and is completed. FINDINGS: Between Oct 12, 2016, and May 24, 2018, 625 (21%) of 2953 survivors assessed for eligibility were recruited and randomly assigned to the intervention (320) or control group (305). Median follow-up was 6 months (IQR 6-6). Patient activation was not significantly different between intervention and control group over time (difference at 6-month follow-up 1·7 [95% CI -0·8-4·1], p=0·41). INTERPRETATION: Oncokompas did not improve the amount of knowledge, skills, and confidence for self-management in cancer survivors. This study contributes to the evidence for the development of tailored strategies for development and implementation of behavioural intervention technologies among cancer survivors. FUNDING: Dutch Cancer Society (KWF Kankerbestrijding).
RCT Entities:
BACKGROUND: Knowledge about the efficacy of behavioural intervention technologies that can be used by cancer survivors independently from a health-care provider is scarce. We aimed to assess the efficacy, reach, and usage of Oncokompas, a web-based eHealth application that supports survivors in self-management by monitoring health-related quality of life (HRQOL) and cancer-generic and tumour-specific symptoms and obtaining tailored feedback with a personalised overview of supportive care options. METHODS: In this non-blinded, randomised, controlled trial, we recruited patients treated at 14 hospitals in the Netherlands for head and neck cancer, colorectal cancer, breast cancer, Hodgkin lymphoma, or non-Hodgkin lymphoma. Adult survivors (aged ≥18 years) were recruited through the Netherlands Cancer Registry (NCR) and invited by their treating physician through the Patient Reported Outcomes Following Initial Treatment and Long term Evaluation of Survivorship (PROFILES) registry. Participants were randomly assigned (1:1) by an independent researcher to the intervention group (access to Oncokompas) or control group (access to Oncokompas after 6 months), by use of block randomisation (block length of 68), stratified by tumour type. The primary outcome was patient activation (knowledge, skills, and confidence for self-management), assessed at baseline, post-intervention, and 3-month and 6-month follow-up. Linear mixed models (intention-to-treat) were used to assess group differences over time from baseline to 6-month follow-up. The trial is registered in the Netherlands Trial Register, NTR5774 and is completed. FINDINGS: Between Oct 12, 2016, and May 24, 2018, 625 (21%) of 2953 survivors assessed for eligibility were recruited and randomly assigned to the intervention (320) or control group (305). Median follow-up was 6 months (IQR 6-6). Patient activation was not significantly different between intervention and control group over time (difference at 6-month follow-up 1·7 [95% CI -0·8-4·1], p=0·41). INTERPRETATION: Oncokompas did not improve the amount of knowledge, skills, and confidence for self-management in cancer survivors. This study contributes to the evidence for the development of tailored strategies for development and implementation of behavioural intervention technologies among cancer survivors. FUNDING: Dutch Cancer Society (KWF Kankerbestrijding).
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