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Improving the quality and efficiency of follow-up after curative treatment for breast cancer – rationale and study design of the MaCare trial

BACKGROUND: After curative treatment for breast cancer women frequently attend scheduled follow-up examinations. Usually the follow-up is most frequent in the first 2–3 years (2–4 times a year); thereafter the frequency is reduced to once a year in most countries. Its main aim is to detect local dis...

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Autores principales: Kimman, Merel L, Voogd, Adri C, Dirksen, Carmen D, Falger, Paul, Hupperets, Pierre, Keymeulen, Kristien, Hebly, Marlene, Dehing, Cary, Lambin, Philippe, Boersma, Liesbeth J
Formato: Texto
Lenguaje:English
Publicado: BioMed Central 2007
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1769389/
https://www.ncbi.nlm.nih.gov/pubmed/17199887
http://dx.doi.org/10.1186/1471-2407-7-1
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author Kimman, Merel L
Voogd, Adri C
Dirksen, Carmen D
Falger, Paul
Hupperets, Pierre
Keymeulen, Kristien
Hebly, Marlene
Dehing, Cary
Lambin, Philippe
Boersma, Liesbeth J
author_facet Kimman, Merel L
Voogd, Adri C
Dirksen, Carmen D
Falger, Paul
Hupperets, Pierre
Keymeulen, Kristien
Hebly, Marlene
Dehing, Cary
Lambin, Philippe
Boersma, Liesbeth J
author_sort Kimman, Merel L
collection PubMed
description BACKGROUND: After curative treatment for breast cancer women frequently attend scheduled follow-up examinations. Usually the follow-up is most frequent in the first 2–3 years (2–4 times a year); thereafter the frequency is reduced to once a year in most countries. Its main aim is to detect local disease recurrence, or a second primary breast cancer, but also to provide information and psychosocial support. However, the cost-effectiveness of these frequent visits is under much debate, leading to a search for less intensive and more cost-effective follow-up strategies. In this paper the design of the MaCare trial is described. This trial compares the cost-effectiveness of four follow-up strategies for curatively treated breast cancer patients. We investigate the costs and effects of nurse-led telephone follow-up and a short educational group programme. METHODS/DESIGN: The MaCare trial is a multi centre randomised clinical trial in which 320 breast cancer patients are randomised into four follow-up strategies, focussed on the first 18 months after treatment: 1) standard follow-up; 2) nurse-led telephone follow-up; 3) arm 1 with the educational group programme; 4) arm 2 with the educational group programme. Data is collected at baseline and 3, 6, 12 and 18 months after treatment. The primary endpoint of the trial is cancer-specific quality of life as measured by the global health/QoL scale of the EORTC QLQ-C30. Secondary outcomes are perceived feelings of control, anxiety, patients' satisfaction with follow-up and costs. A cost-effectiveness analysis will be performed from a societal perspective. DISCUSSION: Reduced follow-up strategies for breast cancer have not yet been widely applied in clinical practice. Improvement of psychosocial support and information to patients could lead to a better acceptance of reduced follow-up. The MaCare trial combines a reduced follow-up strategy with additional psychosocial support. Less frequent follow-up can reduce the burden on medical specialists and costs. The educational group programme can improve QoL of patients, but also less frequent follow-up can improve QoL by reducing the anxiety experienced for each follow-up visit. Results of the trial will provide knowledge on both costs and psychosocial aspects regarding follow-up and are expected in 2009.
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spelling pubmed-17693892007-01-13 Improving the quality and efficiency of follow-up after curative treatment for breast cancer – rationale and study design of the MaCare trial Kimman, Merel L Voogd, Adri C Dirksen, Carmen D Falger, Paul Hupperets, Pierre Keymeulen, Kristien Hebly, Marlene Dehing, Cary Lambin, Philippe Boersma, Liesbeth J BMC Cancer Study Protocol BACKGROUND: After curative treatment for breast cancer women frequently attend scheduled follow-up examinations. Usually the follow-up is most frequent in the first 2–3 years (2–4 times a year); thereafter the frequency is reduced to once a year in most countries. Its main aim is to detect local disease recurrence, or a second primary breast cancer, but also to provide information and psychosocial support. However, the cost-effectiveness of these frequent visits is under much debate, leading to a search for less intensive and more cost-effective follow-up strategies. In this paper the design of the MaCare trial is described. This trial compares the cost-effectiveness of four follow-up strategies for curatively treated breast cancer patients. We investigate the costs and effects of nurse-led telephone follow-up and a short educational group programme. METHODS/DESIGN: The MaCare trial is a multi centre randomised clinical trial in which 320 breast cancer patients are randomised into four follow-up strategies, focussed on the first 18 months after treatment: 1) standard follow-up; 2) nurse-led telephone follow-up; 3) arm 1 with the educational group programme; 4) arm 2 with the educational group programme. Data is collected at baseline and 3, 6, 12 and 18 months after treatment. The primary endpoint of the trial is cancer-specific quality of life as measured by the global health/QoL scale of the EORTC QLQ-C30. Secondary outcomes are perceived feelings of control, anxiety, patients' satisfaction with follow-up and costs. A cost-effectiveness analysis will be performed from a societal perspective. DISCUSSION: Reduced follow-up strategies for breast cancer have not yet been widely applied in clinical practice. Improvement of psychosocial support and information to patients could lead to a better acceptance of reduced follow-up. The MaCare trial combines a reduced follow-up strategy with additional psychosocial support. Less frequent follow-up can reduce the burden on medical specialists and costs. The educational group programme can improve QoL of patients, but also less frequent follow-up can improve QoL by reducing the anxiety experienced for each follow-up visit. Results of the trial will provide knowledge on both costs and psychosocial aspects regarding follow-up and are expected in 2009. BioMed Central 2007-01-02 /pmc/articles/PMC1769389/ /pubmed/17199887 http://dx.doi.org/10.1186/1471-2407-7-1 Text en Copyright © 2007 Kimman 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
Kimman, Merel L
Voogd, Adri C
Dirksen, Carmen D
Falger, Paul
Hupperets, Pierre
Keymeulen, Kristien
Hebly, Marlene
Dehing, Cary
Lambin, Philippe
Boersma, Liesbeth J
Improving the quality and efficiency of follow-up after curative treatment for breast cancer – rationale and study design of the MaCare trial
title Improving the quality and efficiency of follow-up after curative treatment for breast cancer – rationale and study design of the MaCare trial
title_full Improving the quality and efficiency of follow-up after curative treatment for breast cancer – rationale and study design of the MaCare trial
title_fullStr Improving the quality and efficiency of follow-up after curative treatment for breast cancer – rationale and study design of the MaCare trial
title_full_unstemmed Improving the quality and efficiency of follow-up after curative treatment for breast cancer – rationale and study design of the MaCare trial
title_short Improving the quality and efficiency of follow-up after curative treatment for breast cancer – rationale and study design of the MaCare trial
title_sort improving the quality and efficiency of follow-up after curative treatment for breast cancer – rationale and study design of the macare trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1769389/
https://www.ncbi.nlm.nih.gov/pubmed/17199887
http://dx.doi.org/10.1186/1471-2407-7-1
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