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Trans-sectoral care in patients with colorectal cancer: Protocol of the randomized controlled multi-center trial Supportive Cancer Care Networkers (SCAN)
BACKGROUND: Managing therapy-related side-effects and improving health-related quality of life in patients with colorectal cancer is still challenging. The need for an effective management of adverse events and unmet supportive care needs have been widely discussed. In the past decade, interventions...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2015
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4689007/ https://www.ncbi.nlm.nih.gov/pubmed/26694748 http://dx.doi.org/10.1186/s12885-015-2002-6 |
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author | Bauer, Alexander Vordermark, Dirk Seufferlein, Thomas Schmoll, Hans-Joachim Dralle, Henning Mau, Wilfried Unverzagt, Susanne Boese, Stephanie Fach, Eva-Maria Landenberger, Margarete |
author_facet | Bauer, Alexander Vordermark, Dirk Seufferlein, Thomas Schmoll, Hans-Joachim Dralle, Henning Mau, Wilfried Unverzagt, Susanne Boese, Stephanie Fach, Eva-Maria Landenberger, Margarete |
author_sort | Bauer, Alexander |
collection | PubMed |
description | BACKGROUND: Managing therapy-related side-effects and improving health-related quality of life in patients with colorectal cancer is still challenging. The need for an effective management of adverse events and unmet supportive care needs have been widely discussed. In the past decade, interventions by nursing staff gained more and more importance. Evidence suggests that a majority of patients even in early stages of the disease experience substantial impairments potentially resulting in diminished therapy adherence as well as impaired quality of life. However, evidence for the effectiveness of nurse-led interventions on symptom management and quality of life is still very limited. This especially applies to care transitions between different inpatient and outpatient health care providers throughout the course of treatment and aftercare. METHODS/DESIGN: Supportive Cancer Care Networkers (SCAN) is a prospective randomized controlled trial conducted in eight large and middle-sized German cancer centers and municipal hospitals. The target population is adults with colorectal cancer UICC I-III after initial R-0 resection scheduled for adjuvant chemotherapy or guideline-based aftercare only. 370 patients will be randomly assigned to either intervention or control group. Patients in the intervention group will receive an additional support by specialized oncology nurses for eight weeks after discharge from hospital by telephone, consisting of symptom monitoring, counselling on self-assessment and self-management and dealing with individual resources for coping and psychosocial well-being. The primary endpoint will be health-related quality of life (HRQoL) at eight weeks after discharge from the initial treating hospital. DISCUSSION: The presented SCAN trial is to provide information that will be useful to advance our understanding of complex interdependencies between symptom severity, supportive care needs, functioning and the risk for diminished HRQoL. Most importantly, these patient-reported outcomes are not fully implemented in today’s clinical routine practice potentially resulting in therapy cessations and lower chemotherapy treatment rates for colorectal cancer especially in older patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT01651832. |
format | Online Article Text |
id | pubmed-4689007 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-46890072015-12-24 Trans-sectoral care in patients with colorectal cancer: Protocol of the randomized controlled multi-center trial Supportive Cancer Care Networkers (SCAN) Bauer, Alexander Vordermark, Dirk Seufferlein, Thomas Schmoll, Hans-Joachim Dralle, Henning Mau, Wilfried Unverzagt, Susanne Boese, Stephanie Fach, Eva-Maria Landenberger, Margarete BMC Cancer Study Protocol BACKGROUND: Managing therapy-related side-effects and improving health-related quality of life in patients with colorectal cancer is still challenging. The need for an effective management of adverse events and unmet supportive care needs have been widely discussed. In the past decade, interventions by nursing staff gained more and more importance. Evidence suggests that a majority of patients even in early stages of the disease experience substantial impairments potentially resulting in diminished therapy adherence as well as impaired quality of life. However, evidence for the effectiveness of nurse-led interventions on symptom management and quality of life is still very limited. This especially applies to care transitions between different inpatient and outpatient health care providers throughout the course of treatment and aftercare. METHODS/DESIGN: Supportive Cancer Care Networkers (SCAN) is a prospective randomized controlled trial conducted in eight large and middle-sized German cancer centers and municipal hospitals. The target population is adults with colorectal cancer UICC I-III after initial R-0 resection scheduled for adjuvant chemotherapy or guideline-based aftercare only. 370 patients will be randomly assigned to either intervention or control group. Patients in the intervention group will receive an additional support by specialized oncology nurses for eight weeks after discharge from hospital by telephone, consisting of symptom monitoring, counselling on self-assessment and self-management and dealing with individual resources for coping and psychosocial well-being. The primary endpoint will be health-related quality of life (HRQoL) at eight weeks after discharge from the initial treating hospital. DISCUSSION: The presented SCAN trial is to provide information that will be useful to advance our understanding of complex interdependencies between symptom severity, supportive care needs, functioning and the risk for diminished HRQoL. Most importantly, these patient-reported outcomes are not fully implemented in today’s clinical routine practice potentially resulting in therapy cessations and lower chemotherapy treatment rates for colorectal cancer especially in older patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT01651832. BioMed Central 2015-12-22 /pmc/articles/PMC4689007/ /pubmed/26694748 http://dx.doi.org/10.1186/s12885-015-2002-6 Text en © Bauer et al. 2015 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Study Protocol Bauer, Alexander Vordermark, Dirk Seufferlein, Thomas Schmoll, Hans-Joachim Dralle, Henning Mau, Wilfried Unverzagt, Susanne Boese, Stephanie Fach, Eva-Maria Landenberger, Margarete Trans-sectoral care in patients with colorectal cancer: Protocol of the randomized controlled multi-center trial Supportive Cancer Care Networkers (SCAN) |
title | Trans-sectoral care in patients with colorectal cancer: Protocol of the randomized controlled multi-center trial Supportive Cancer Care Networkers (SCAN) |
title_full | Trans-sectoral care in patients with colorectal cancer: Protocol of the randomized controlled multi-center trial Supportive Cancer Care Networkers (SCAN) |
title_fullStr | Trans-sectoral care in patients with colorectal cancer: Protocol of the randomized controlled multi-center trial Supportive Cancer Care Networkers (SCAN) |
title_full_unstemmed | Trans-sectoral care in patients with colorectal cancer: Protocol of the randomized controlled multi-center trial Supportive Cancer Care Networkers (SCAN) |
title_short | Trans-sectoral care in patients with colorectal cancer: Protocol of the randomized controlled multi-center trial Supportive Cancer Care Networkers (SCAN) |
title_sort | trans-sectoral care in patients with colorectal cancer: protocol of the randomized controlled multi-center trial supportive cancer care networkers (scan) |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4689007/ https://www.ncbi.nlm.nih.gov/pubmed/26694748 http://dx.doi.org/10.1186/s12885-015-2002-6 |
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