ROGYcare: The Impact of a Cancer Survivorship Care Plan on Patient Reported Outcomes and Health Care Providers
NCT ID: NCT01185626
Last Updated: 2017-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
396 participants
INTERVENTIONAL
2011-04-30
2016-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Usual care
The gynaecological oncologist (GO) provides care as usual. Currently, hospitals provide follow-up following the Dutch guidelines, meaning that they see their patients on given time points based on the number of years after diagnosis. Most hospitals give their patients leaflets regarding the diagnosis and treatment they receive, however none of them provide personalized information. All information is given during the initial treatment phase, but none of the GOs give additional information during follow-up. None of the GOs is actively screening on psychosocial needs. As this might change in time, we will ask the providers and patients about the type of information they provide, respectively, receive.
No interventions assigned to this group
SCP care
After initial treatment, the GO provides the patient with a paper SCP and takes time to discuss all items in the SCP. Each time during follow-up meetings between patient and GO, the patient will receive an updated SCP if applicable. The paper SCP is extracted from the online registration system 'ROGY' (Registrationsystem Oncological GYnaecology) and combines personal patient and disease data with tailored information that is related to the specific situation of this patient. Recurrences, toxicities or additionally involved specialists will be registered in ROGY and automatically updated in the personal SCP.
SCP care
Interventions
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SCP care
Eligibility Criteria
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Inclusion Criteria
* The patients have to be able to complete a Dutch questionnaire.
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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Comprehensive Cancer Centre The Netherlands
OTHER
Dutch Cancer Society
OTHER
Lonneke van de Poll-Franse
OTHER
Responsible Party
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Lonneke van de Poll-Franse
Dr. Prof.
Principal Investigators
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Lonneke V van de Poll-Franse, Dr. Prof.
Role: PRINCIPAL_INVESTIGATOR
Tilburg University, The Netherlands
Nicole PM Ezendam, Dr.
Role: PRINCIPAL_INVESTIGATOR
The Netherlands Comprehensive Cancer Organisation
Locations
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Jeroen Bosch Ziekenhuis
's-Hertogenbosch, , Netherlands
Amphia Ziekenhuis
Breda, , Netherlands
Catharina-Ziekenhuis
Eindhoven, , Netherlands
Maxima Medisch Centrum
Eindhoven, , Netherlands
St. Anna Ziekenhuis
Geldrop, , Netherlands
Elkerliek Ziekenhuis
Helmond, , Netherlands
Maastricht Universitair Medisch Centrum
Maastricht, , Netherlands
Orbis Medisch Centrum
Sittard, , Netherlands
St. Elisabeth Hospital
Tilburg, , Netherlands
TweeSteden Ziekenhuis
Tilburg, , Netherlands
VieCuri Medisch Centrum
Venlo, , Netherlands
St. Jans Gasthuis
Weert, , Netherlands
Countries
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References
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van de Poll-Franse LV, Nicolaije KA, Vos MC, Pijnenborg JM, Boll D, Husson O, Ezendam NP, Boss EA, Hermans RH, Engelhart KC, Haartsen JE, Pijlman BM, Feijen HW, Mertens HJ, Nolting WE, van Beek JJ, Roukema JA, Kruitwagen RF. The impact of a cancer Survivorship Care Plan on gynecological cancer patient and health care provider reported outcomes (ROGY Care): study protocol for a pragmatic cluster randomized controlled trial. Trials. 2011 Dec 5;12:256. doi: 10.1186/1745-6215-12-256.
Nicolaije KA, Ezendam NP, Vos MC, Pijnenborg JM, Boll D, Boss EA, Hermans RH, Engelhart KC, Haartsen JE, Pijlman BM, van Loon-Baelemans IE, Mertens HJ, Nolting WE, van Beek JJ, Roukema JA, Zijlstra WP, Kruitwagen RF, van de Poll-Franse LV. Impact of an Automatically Generated Cancer Survivorship Care Plan on Patient-Reported Outcomes in Routine Clinical Practice: Longitudinal Outcomes of a Pragmatic, Cluster Randomized Trial. J Clin Oncol. 2015 Nov 1;33(31):3550-9. doi: 10.1200/JCO.2014.60.3399. Epub 2015 Aug 24.
Ezendam NP, Nicolaije KA, Kruitwagen RF, Pijnenborg JM, Vos MC, Boll D, van Bommel M, van de Poll-Franse LV. Survivorship Care Plans to inform the primary care physician: results from the ROGY care pragmatic cluster randomized controlled trial. J Cancer Surviv. 2014 Dec;8(4):595-602. doi: 10.1007/s11764-014-0368-0. Epub 2014 May 28.
Nicolaije KA, Ezendam NP, Vos MC, Pijnenborg JM, van de Poll-Franse LV, Kruitwagen RF. Oncology providers' evaluation of the use of an automatically generated cancer survivorship care plan: longitudinal results from the ROGY Care trial. J Cancer Surviv. 2014 Jun;8(2):248-59. doi: 10.1007/s11764-013-0327-1. Epub 2013 Dec 20.
Nicolaije KA, Ezendam NP, Pijnenborg JM, Boll D, Vos MC, Kruitwagen RF, van de Poll-Franse LV. Paper-Based Survivorship Care Plans May be Less Helpful for Cancer Patients Who Search for Disease-Related Information on the Internet: Results of the Registrationsystem Oncological Gynecology (ROGY) Care Randomized Trial. J Med Internet Res. 2016 Jul 8;18(7):e162. doi: 10.2196/jmir.4914.
de Rooij BH, Ezendam NP, Nicolaije KA, Vos MC, Pijnenborg JM, Boll D, Kruitwagen RF, van de Poll-Franse LV. Factors influencing implementation of a survivorship care plan-a quantitative process evaluation of the ROGY Care trial. J Cancer Surviv. 2017 Feb;11(1):64-73. doi: 10.1007/s11764-016-0562-3. Epub 2016 Aug 1.
van Broekhoven MECL, de Rooij BH, Pijnenborg JMA, Vos MC, Boll D, Kruitwagen RFPM, van de Poll-Franse LV, Ezendam NPM. Illness perceptions and changes in lifestyle following a gynecological cancer diagnosis: A longitudinal analysis. Gynecol Oncol. 2017 May;145(2):310-318. doi: 10.1016/j.ygyno.2017.02.037. Epub 2017 Mar 6.
de Rooij BH, Ezendam NPM, Nicolaije KAH, Caroline Vos M, Pijnenborg JMA, Boll D, Boss EA, Hermans RHM, Engelhart KCM, Haartsen JE, Pijlman BM, van Loon-Baelemans IEAM, Mertens HJMM, Nolting WE, van Beek JJ, Roukema JA, Kruitwagen RFPM, van de Poll-Franse LV. Effects of Survivorship Care Plans on patient reported outcomes in ovarian cancer during 2-year follow-up - The ROGY care trial. Gynecol Oncol. 2017 May;145(2):319-328. doi: 10.1016/j.ygyno.2017.02.041. Epub 2017 Mar 7.
Driessen KAJ, de Rooij BH, Vos MC, Boll D, Pijnenborg JMA, Hoedjes M, Beijer S, Ezendam NPM. Cancer-related psychosocial factors and self-reported changes in lifestyle among gynecological cancer survivors: cross-sectional analysis of PROFILES registry data. Support Care Cancer. 2022 Feb;30(2):1199-1207. doi: 10.1007/s00520-021-06433-0. Epub 2021 Aug 28.
de Rooij BH, Ezendam NPM, Nicolaije KAH, Lodder P, Vos MC, Pijnenborg JMA, Boll D, Kruitwagen RFPM, van de Poll-Franse LV. Survivorship care plans have a negative impact on long-term quality of life and anxiety through more threatening illness perceptions in gynecological cancer patients: the ROGY care trial. Qual Life Res. 2018 Jun;27(6):1533-1544. doi: 10.1007/s11136-018-1825-4. Epub 2018 Mar 6.
Other Identifiers
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UVT 2010-4743
Identifier Type: -
Identifier Source: org_study_id
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