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Distress and quality of life after autologous stem cell transplantation: a randomized clinical trial to evaluate the outcome of a web-based stepped care intervention

BACKGROUND: Psychological distress (i.e. depression and anxiety) is a strong predictor of functional status and other aspects of quality of life in autologous stem cell transplantation following high-dose chemotherapy. Treatment of psychological distress is hypothesized to result in improvement of f...

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Autores principales: Braamse, Annemarie MJ, van Meijel, Berno, Visser, Otto, van Oppen, Patricia, Boenink, Annette D, Eeltink, Corien, Cuijpers, Pim, Huijgens, Peter C, Beekman, Aartjan TF, Dekker, Joost
Formato: Texto
Lenguaje:English
Publicado: BioMed Central 2010
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2913960/
https://www.ncbi.nlm.nih.gov/pubmed/20609251
http://dx.doi.org/10.1186/1471-2407-10-361
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author Braamse, Annemarie MJ
van Meijel, Berno
Visser, Otto
van Oppen, Patricia
Boenink, Annette D
Eeltink, Corien
Cuijpers, Pim
Huijgens, Peter C
Beekman, Aartjan TF
Dekker, Joost
author_facet Braamse, Annemarie MJ
van Meijel, Berno
Visser, Otto
van Oppen, Patricia
Boenink, Annette D
Eeltink, Corien
Cuijpers, Pim
Huijgens, Peter C
Beekman, Aartjan TF
Dekker, Joost
author_sort Braamse, Annemarie MJ
collection PubMed
description BACKGROUND: Psychological distress (i.e. depression and anxiety) is a strong predictor of functional status and other aspects of quality of life in autologous stem cell transplantation following high-dose chemotherapy. Treatment of psychological distress is hypothesized to result in improvement of functional status and other aspects of quality of life. The aim is to evaluate the outcome of stepped care for psychological distress on functional status and other aspects of quality of life in patients with hematological malignancy treated with autologous stem cell transplantation. METHODS/DESIGN: The study is designed as a randomized clinical trial with 2 treatment arms: a stepped care intervention program versus care as usual. Patients are randomized immediately pre transplant. Stepped care and care as usual are initiated after a 6 weeks buffer period. Outcome is evaluated at 13, 30, and 42 weeks post transplant. In the experimental group, the first step includes an Internet-based self-help program. If psychological distress persists after the self-help intervention, the second step of the program is executed, i.e. a diagnostic evaluation and a standardized interview, yielding a problem analysis. Based on this information, a contract is made with the patient and treatment is provided consisting of individual face-to-face counseling, medication, or referral to other services. Care as usual comprises an interview with the patient, on ad hoc basis; emotional support and advice, on ad hoc basis; if urgent problems emerge, the patient is referred to other services. Primary outcome variables are psychological distress and functional status. Data are analyzed according to the intention to treat-principle. DISCUSSION: This study has several innovative characteristics. First, the outcome of the intervention for psychological distress in patients with hematological malignancy treated with autologous stem cell transplantation is evaluated in a randomized controlled study. Second, the impact of the intervention on functional status is evaluated: it is hypothesized that reduction of psychological distress results in improved functional status. Furthermore, the intervention concerns an Internet-based treatment in the first step. Finally, the intervention is characterized by an emphasis on self-management, efficiency, and a multi-disciplinary approach with nurses taking up a central role. TRIAL REGISTRATION: NTR1770
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spelling pubmed-29139602010-08-03 Distress and quality of life after autologous stem cell transplantation: a randomized clinical trial to evaluate the outcome of a web-based stepped care intervention Braamse, Annemarie MJ van Meijel, Berno Visser, Otto van Oppen, Patricia Boenink, Annette D Eeltink, Corien Cuijpers, Pim Huijgens, Peter C Beekman, Aartjan TF Dekker, Joost BMC Cancer Study Protocol BACKGROUND: Psychological distress (i.e. depression and anxiety) is a strong predictor of functional status and other aspects of quality of life in autologous stem cell transplantation following high-dose chemotherapy. Treatment of psychological distress is hypothesized to result in improvement of functional status and other aspects of quality of life. The aim is to evaluate the outcome of stepped care for psychological distress on functional status and other aspects of quality of life in patients with hematological malignancy treated with autologous stem cell transplantation. METHODS/DESIGN: The study is designed as a randomized clinical trial with 2 treatment arms: a stepped care intervention program versus care as usual. Patients are randomized immediately pre transplant. Stepped care and care as usual are initiated after a 6 weeks buffer period. Outcome is evaluated at 13, 30, and 42 weeks post transplant. In the experimental group, the first step includes an Internet-based self-help program. If psychological distress persists after the self-help intervention, the second step of the program is executed, i.e. a diagnostic evaluation and a standardized interview, yielding a problem analysis. Based on this information, a contract is made with the patient and treatment is provided consisting of individual face-to-face counseling, medication, or referral to other services. Care as usual comprises an interview with the patient, on ad hoc basis; emotional support and advice, on ad hoc basis; if urgent problems emerge, the patient is referred to other services. Primary outcome variables are psychological distress and functional status. Data are analyzed according to the intention to treat-principle. DISCUSSION: This study has several innovative characteristics. First, the outcome of the intervention for psychological distress in patients with hematological malignancy treated with autologous stem cell transplantation is evaluated in a randomized controlled study. Second, the impact of the intervention on functional status is evaluated: it is hypothesized that reduction of psychological distress results in improved functional status. Furthermore, the intervention concerns an Internet-based treatment in the first step. Finally, the intervention is characterized by an emphasis on self-management, efficiency, and a multi-disciplinary approach with nurses taking up a central role. TRIAL REGISTRATION: NTR1770 BioMed Central 2010-07-07 /pmc/articles/PMC2913960/ /pubmed/20609251 http://dx.doi.org/10.1186/1471-2407-10-361 Text en Copyright ©2010 Braamse 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
Braamse, Annemarie MJ
van Meijel, Berno
Visser, Otto
van Oppen, Patricia
Boenink, Annette D
Eeltink, Corien
Cuijpers, Pim
Huijgens, Peter C
Beekman, Aartjan TF
Dekker, Joost
Distress and quality of life after autologous stem cell transplantation: a randomized clinical trial to evaluate the outcome of a web-based stepped care intervention
title Distress and quality of life after autologous stem cell transplantation: a randomized clinical trial to evaluate the outcome of a web-based stepped care intervention
title_full Distress and quality of life after autologous stem cell transplantation: a randomized clinical trial to evaluate the outcome of a web-based stepped care intervention
title_fullStr Distress and quality of life after autologous stem cell transplantation: a randomized clinical trial to evaluate the outcome of a web-based stepped care intervention
title_full_unstemmed Distress and quality of life after autologous stem cell transplantation: a randomized clinical trial to evaluate the outcome of a web-based stepped care intervention
title_short Distress and quality of life after autologous stem cell transplantation: a randomized clinical trial to evaluate the outcome of a web-based stepped care intervention
title_sort distress and quality of life after autologous stem cell transplantation: a randomized clinical trial to evaluate the outcome of a web-based stepped care intervention
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2913960/
https://www.ncbi.nlm.nih.gov/pubmed/20609251
http://dx.doi.org/10.1186/1471-2407-10-361
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