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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
BACKGROUND: There is a need for improvement of information provision and post-treatment care for cancer survivors. A Survivorship Care Plan (SCP) is recommended by the American Institute of Medicine and the Dutch Health Council, which is a summary of patients' course of treatment as a formal do...
Autores principales: | , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2011
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3286432/ https://www.ncbi.nlm.nih.gov/pubmed/22141750 http://dx.doi.org/10.1186/1745-6215-12-256 |
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author | van de Poll-Franse, Lonneke V Nicolaije, Kim AH Vos, Maria C Pijnenborg, Johanna MA Boll, Dorry Husson, Olga Ezendam, Nicole PM Boss, Erik A Hermans, Ralph HM Engelhart, Karin CM Haartsen, Joke E Pijlman, Brenda M Feijen, Harrie WH Mertens, Helena JMM Nolting, Willem E van Beek, Johannes J Roukema, Jan A Kruitwagen, Roy FPM |
author_facet | van de Poll-Franse, Lonneke V Nicolaije, Kim AH Vos, Maria C Pijnenborg, Johanna MA Boll, Dorry Husson, Olga Ezendam, Nicole PM Boss, Erik A Hermans, Ralph HM Engelhart, Karin CM Haartsen, Joke E Pijlman, Brenda M Feijen, Harrie WH Mertens, Helena JMM Nolting, Willem E van Beek, Johannes J Roukema, Jan A Kruitwagen, Roy FPM |
author_sort | van de Poll-Franse, Lonneke V |
collection | PubMed |
description | BACKGROUND: There is a need for improvement of information provision and post-treatment care for cancer survivors. A Survivorship Care Plan (SCP) is recommended by the American Institute of Medicine and the Dutch Health Council, which is a summary of patients' course of treatment as a formal document, and includes recommendations for subsequent cancer surveillance, management of late effects, and strategies for health promotion. Until now, evidence on the effects of implementing the SCP in clinical practice is lacking. The rationale and study design of a pragmatic cluster randomized trial, aiming to assess the impact of SCP care in routine clinical practice, is presented. METHODS/DESIGN: A web-based patient registration system 'Registrationsystem Oncological GYnecology' (ROGY) is used by gynecologists in the South of the Netherlands since 2006. A personalized SCP can automatically be generated out of ROGY. In this pragmatic cluster randomized controlled trial, 12 hospitals are randomized to either 'usual care' or 'SCP care'. In patients with 'usual care', the gynecologist provides care as usual. In patients with 'SCP care', information about the tumor stage and treatment is personally discussed with the patient and a document is handed to the patient. Prospectively, all patients diagnosed with endometrial or ovarian cancer in the participating hospitals will be approached for study participation. Patients will complete questionnaires after surgery, and before additional treatment, and after 6, 12, 18 and 24 months. In addition, health care providers will be asked their opinion about implementation of SCP care. Primary outcome is defined as patient satisfaction with information provision and care. Secondary outcomes are illness perception, health-related quality of life, health care use, prevalence, course and referral rate of survivors with psychosocial distress, and health care providers' evaluation of SCP care. DISCUSSION: The ROGY Care trial will help to gain insight into the impact of SCP care on patient reported outcomes, and on the evaluation of cancer survivors and health care providers of the different elements of the SCP. Therefore, results will contribute to efforts to improve quality of care for cancer survivors. TRIAL REGISTRATION: Trial Registration: http://www.ClinicalTrials.gov. Identifier: NCT01185626 Medical Research Ethics Committee Reference Number: NL33429.008.10 Grant Reference Number: UVT2010-4743 |
format | Online Article Text |
id | pubmed-3286432 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2011 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-32864322012-02-25 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 van de Poll-Franse, Lonneke V Nicolaije, Kim AH Vos, Maria C Pijnenborg, Johanna MA Boll, Dorry Husson, Olga Ezendam, Nicole PM Boss, Erik A Hermans, Ralph HM Engelhart, Karin CM Haartsen, Joke E Pijlman, Brenda M Feijen, Harrie WH Mertens, Helena JMM Nolting, Willem E van Beek, Johannes J Roukema, Jan A Kruitwagen, Roy FPM Trials Study Protocol BACKGROUND: There is a need for improvement of information provision and post-treatment care for cancer survivors. A Survivorship Care Plan (SCP) is recommended by the American Institute of Medicine and the Dutch Health Council, which is a summary of patients' course of treatment as a formal document, and includes recommendations for subsequent cancer surveillance, management of late effects, and strategies for health promotion. Until now, evidence on the effects of implementing the SCP in clinical practice is lacking. The rationale and study design of a pragmatic cluster randomized trial, aiming to assess the impact of SCP care in routine clinical practice, is presented. METHODS/DESIGN: A web-based patient registration system 'Registrationsystem Oncological GYnecology' (ROGY) is used by gynecologists in the South of the Netherlands since 2006. A personalized SCP can automatically be generated out of ROGY. In this pragmatic cluster randomized controlled trial, 12 hospitals are randomized to either 'usual care' or 'SCP care'. In patients with 'usual care', the gynecologist provides care as usual. In patients with 'SCP care', information about the tumor stage and treatment is personally discussed with the patient and a document is handed to the patient. Prospectively, all patients diagnosed with endometrial or ovarian cancer in the participating hospitals will be approached for study participation. Patients will complete questionnaires after surgery, and before additional treatment, and after 6, 12, 18 and 24 months. In addition, health care providers will be asked their opinion about implementation of SCP care. Primary outcome is defined as patient satisfaction with information provision and care. Secondary outcomes are illness perception, health-related quality of life, health care use, prevalence, course and referral rate of survivors with psychosocial distress, and health care providers' evaluation of SCP care. DISCUSSION: The ROGY Care trial will help to gain insight into the impact of SCP care on patient reported outcomes, and on the evaluation of cancer survivors and health care providers of the different elements of the SCP. Therefore, results will contribute to efforts to improve quality of care for cancer survivors. TRIAL REGISTRATION: Trial Registration: http://www.ClinicalTrials.gov. Identifier: NCT01185626 Medical Research Ethics Committee Reference Number: NL33429.008.10 Grant Reference Number: UVT2010-4743 BioMed Central 2011-12-05 /pmc/articles/PMC3286432/ /pubmed/22141750 http://dx.doi.org/10.1186/1745-6215-12-256 Text en Copyright ©2011 van de Poll-Franse et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Study Protocol van de Poll-Franse, Lonneke V Nicolaije, Kim AH Vos, Maria C Pijnenborg, Johanna MA Boll, Dorry Husson, Olga Ezendam, Nicole PM Boss, Erik A Hermans, Ralph HM Engelhart, Karin CM Haartsen, Joke E Pijlman, Brenda M Feijen, Harrie WH Mertens, Helena JMM Nolting, Willem E van Beek, Johannes J Roukema, Jan A Kruitwagen, Roy FPM 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3286432/ https://www.ncbi.nlm.nih.gov/pubmed/22141750 http://dx.doi.org/10.1186/1745-6215-12-256 |
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