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Design of the study: How can health care help female breast cancer patients reduce their stress symptoms? A randomized intervention study with stepped-care

BACKGROUND: A life threatening illness such as breast cancer can lead to a secondary diagnosis of PTSD (post traumatic stress disorder) with intrusive thoughts and avoidance as major symptoms. In a former study by the research group, 80% of the patients with breast cancer reported a high level of st...

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Autores principales: Nordin, Karin, Rissanen, Ritva, Ahlgren, Johan, Burell, Gunilla, Fjällskog, Marie-Louise, Börjesson, Susanne, Arving, Cecilia
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2012
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3422160/
https://www.ncbi.nlm.nih.gov/pubmed/22559200
http://dx.doi.org/10.1186/1471-2407-12-167
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author Nordin, Karin
Rissanen, Ritva
Ahlgren, Johan
Burell, Gunilla
Fjällskog, Marie-Louise
Börjesson, Susanne
Arving, Cecilia
author_facet Nordin, Karin
Rissanen, Ritva
Ahlgren, Johan
Burell, Gunilla
Fjällskog, Marie-Louise
Börjesson, Susanne
Arving, Cecilia
author_sort Nordin, Karin
collection PubMed
description BACKGROUND: A life threatening illness such as breast cancer can lead to a secondary diagnosis of PTSD (post traumatic stress disorder) with intrusive thoughts and avoidance as major symptoms. In a former study by the research group, 80% of the patients with breast cancer reported a high level of stress symptoms close to the diagnosis, such as intrusive thoughts and avoidance behavior. These symptoms remained high throughout the study. The present paper presents the design of a randomized study evaluating the effectiveness and cost-effectiveness of a stress management intervention using a stepped-care design. METHOD: Female patients over the age of 18, with a recent diagnosis of breast cancer and scheduled for adjuvant treatment in the form of chemotherapy, radiation therapy and/or hormonal therapy are eligible and will consecutively be included in the study. The study is a prospective longitudinal intervention study with a stepped-care approach, where patients will be randomised to one of two interventions in the final stage of treatment. The first step is a low intensity stress-management intervention that is given to all patients. Patients who do not respond to this level are thereafter given more intensive treatment at later steps in the program and will be randomized to more intensive stress-management intervention in a group setting or individually. The primary out-come is subjective distress (intrusion and avoidance) assessed by the Impact of Event Scale (IES). According to the power-analyses, 300 patients are planned to be included in the study and will be followed for one year. Other outcomes are anxiety, depression, quality of life, fatigue, stress in daily living and utilization of hospital services. This will be assessed with well-known psychometric tested questionnaires. Also, the cost-effectiveness of the intervention given in group or individually will be evaluated. DISCUSSION: This randomized clinical trial will provide additional empirical evidence regarding the effectiveness of a stress-management program given in group or individually during adjuvant therapy in terms of decreased stress, minimizing fatigue, and maintaining or enhancing patients’ quality of life and psychological well-being. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01555645
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spelling pubmed-34221602012-08-18 Design of the study: How can health care help female breast cancer patients reduce their stress symptoms? A randomized intervention study with stepped-care Nordin, Karin Rissanen, Ritva Ahlgren, Johan Burell, Gunilla Fjällskog, Marie-Louise Börjesson, Susanne Arving, Cecilia BMC Cancer Study Protocol BACKGROUND: A life threatening illness such as breast cancer can lead to a secondary diagnosis of PTSD (post traumatic stress disorder) with intrusive thoughts and avoidance as major symptoms. In a former study by the research group, 80% of the patients with breast cancer reported a high level of stress symptoms close to the diagnosis, such as intrusive thoughts and avoidance behavior. These symptoms remained high throughout the study. The present paper presents the design of a randomized study evaluating the effectiveness and cost-effectiveness of a stress management intervention using a stepped-care design. METHOD: Female patients over the age of 18, with a recent diagnosis of breast cancer and scheduled for adjuvant treatment in the form of chemotherapy, radiation therapy and/or hormonal therapy are eligible and will consecutively be included in the study. The study is a prospective longitudinal intervention study with a stepped-care approach, where patients will be randomised to one of two interventions in the final stage of treatment. The first step is a low intensity stress-management intervention that is given to all patients. Patients who do not respond to this level are thereafter given more intensive treatment at later steps in the program and will be randomized to more intensive stress-management intervention in a group setting or individually. The primary out-come is subjective distress (intrusion and avoidance) assessed by the Impact of Event Scale (IES). According to the power-analyses, 300 patients are planned to be included in the study and will be followed for one year. Other outcomes are anxiety, depression, quality of life, fatigue, stress in daily living and utilization of hospital services. This will be assessed with well-known psychometric tested questionnaires. Also, the cost-effectiveness of the intervention given in group or individually will be evaluated. DISCUSSION: This randomized clinical trial will provide additional empirical evidence regarding the effectiveness of a stress-management program given in group or individually during adjuvant therapy in terms of decreased stress, minimizing fatigue, and maintaining or enhancing patients’ quality of life and psychological well-being. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01555645 BioMed Central 2012-05-04 /pmc/articles/PMC3422160/ /pubmed/22559200 http://dx.doi.org/10.1186/1471-2407-12-167 Text en Copyright ©2012 Nordin 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
Nordin, Karin
Rissanen, Ritva
Ahlgren, Johan
Burell, Gunilla
Fjällskog, Marie-Louise
Börjesson, Susanne
Arving, Cecilia
Design of the study: How can health care help female breast cancer patients reduce their stress symptoms? A randomized intervention study with stepped-care
title Design of the study: How can health care help female breast cancer patients reduce their stress symptoms? A randomized intervention study with stepped-care
title_full Design of the study: How can health care help female breast cancer patients reduce their stress symptoms? A randomized intervention study with stepped-care
title_fullStr Design of the study: How can health care help female breast cancer patients reduce their stress symptoms? A randomized intervention study with stepped-care
title_full_unstemmed Design of the study: How can health care help female breast cancer patients reduce their stress symptoms? A randomized intervention study with stepped-care
title_short Design of the study: How can health care help female breast cancer patients reduce their stress symptoms? A randomized intervention study with stepped-care
title_sort design of the study: how can health care help female breast cancer patients reduce their stress symptoms? a randomized intervention study with stepped-care
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3422160/
https://www.ncbi.nlm.nih.gov/pubmed/22559200
http://dx.doi.org/10.1186/1471-2407-12-167
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