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Integral strategy to supportive care in breast cancer survivors through occupational therapy and a m-health system: design of a randomized clinical trial

BACKGROUND: Technological support using e-health mobile applications (m-health) is a promising strategy to improve the adherence to healthy lifestyles in breast cancer survivors (excess in energy intake or low physical activity are determinants of the risk of recurrence, second cancers and cancer mo...

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Autores principales: Lozano-Lozano, Mario, Martín-Martín, Lydia, Galiano-Castillo, Noelia, Álvarez-Salvago, Francisco, Cantarero-Villanueva, Irene, Fernández-Lao, Carolina, Sánchez-Salado, Carmen, Arroyo-Morales, Manuel
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5124301/
https://www.ncbi.nlm.nih.gov/pubmed/27887610
http://dx.doi.org/10.1186/s12911-016-0394-0
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author Lozano-Lozano, Mario
Martín-Martín, Lydia
Galiano-Castillo, Noelia
Álvarez-Salvago, Francisco
Cantarero-Villanueva, Irene
Fernández-Lao, Carolina
Sánchez-Salado, Carmen
Arroyo-Morales, Manuel
author_facet Lozano-Lozano, Mario
Martín-Martín, Lydia
Galiano-Castillo, Noelia
Álvarez-Salvago, Francisco
Cantarero-Villanueva, Irene
Fernández-Lao, Carolina
Sánchez-Salado, Carmen
Arroyo-Morales, Manuel
author_sort Lozano-Lozano, Mario
collection PubMed
description BACKGROUND: Technological support using e-health mobile applications (m-health) is a promising strategy to improve the adherence to healthy lifestyles in breast cancer survivors (excess in energy intake or low physical activity are determinants of the risk of recurrence, second cancers and cancer mortality). Moreover, cancer rehabilitation programs supervised by health professionals are needed due to the inherent characteristics of these breast cancer patients. Our main objective is to compare the clinical efficacy of a m-health lifestyle intervention system alone versus an integral strategy to improve Quality of Life in breast cancer survivors. METHODS: This therapeutic superiority study will use a two-arm, assessor blinded parallel RCT design. Women will be eligible if: they are diagnosed of stage I, II or III-A breast cancer; are between 25 and 75 years old; have a Body Mass Index > 25 kg/m(2); they have basic ability to use mobile apps; they had completed adjuvant therapy except for hormone therapy; and they have some functional shoulder limitations. Participants will be randomized to one of the following groups: integral group will use a mobile application (BENECA APP) and will receive a face-to-face rehabilitation (8-weeks); m-health group will use the BENECA app for 2-months and will received usual care information. Study endpoints will be assessed after 8 weeks and 6 months. The primary outcome will be Quality of Life measured by The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core and breast module. The secondary outcomes: body composition; upper-body functionality (handgrip, Disability of the Arm, Shoulder and Hand questionnaire, goniometry); cognitive function (Wechsler Adult Intelligence Scale, Trail Making Test); anxiety and depression (Hospital Anxiety and Depression Scale); physical fitness (Short version of the Minnesota Leisure Time Physical Activity Questionnaire, Self-Efficacy Scale for Physical Activity); accelerometry and lymphedema. DISCUSSION: This study has been designed to seek to address the new needs for support and treatment of breast cancer survivors, reflecting the emerging need to merge new low cost treatment options with much-needed involvement of health professionals in this type of patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02817724 (date of registration: 22/06/2016).
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spelling pubmed-51243012016-12-08 Integral strategy to supportive care in breast cancer survivors through occupational therapy and a m-health system: design of a randomized clinical trial Lozano-Lozano, Mario Martín-Martín, Lydia Galiano-Castillo, Noelia Álvarez-Salvago, Francisco Cantarero-Villanueva, Irene Fernández-Lao, Carolina Sánchez-Salado, Carmen Arroyo-Morales, Manuel BMC Med Inform Decis Mak Study Protocol BACKGROUND: Technological support using e-health mobile applications (m-health) is a promising strategy to improve the adherence to healthy lifestyles in breast cancer survivors (excess in energy intake or low physical activity are determinants of the risk of recurrence, second cancers and cancer mortality). Moreover, cancer rehabilitation programs supervised by health professionals are needed due to the inherent characteristics of these breast cancer patients. Our main objective is to compare the clinical efficacy of a m-health lifestyle intervention system alone versus an integral strategy to improve Quality of Life in breast cancer survivors. METHODS: This therapeutic superiority study will use a two-arm, assessor blinded parallel RCT design. Women will be eligible if: they are diagnosed of stage I, II or III-A breast cancer; are between 25 and 75 years old; have a Body Mass Index > 25 kg/m(2); they have basic ability to use mobile apps; they had completed adjuvant therapy except for hormone therapy; and they have some functional shoulder limitations. Participants will be randomized to one of the following groups: integral group will use a mobile application (BENECA APP) and will receive a face-to-face rehabilitation (8-weeks); m-health group will use the BENECA app for 2-months and will received usual care information. Study endpoints will be assessed after 8 weeks and 6 months. The primary outcome will be Quality of Life measured by The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core and breast module. The secondary outcomes: body composition; upper-body functionality (handgrip, Disability of the Arm, Shoulder and Hand questionnaire, goniometry); cognitive function (Wechsler Adult Intelligence Scale, Trail Making Test); anxiety and depression (Hospital Anxiety and Depression Scale); physical fitness (Short version of the Minnesota Leisure Time Physical Activity Questionnaire, Self-Efficacy Scale for Physical Activity); accelerometry and lymphedema. DISCUSSION: This study has been designed to seek to address the new needs for support and treatment of breast cancer survivors, reflecting the emerging need to merge new low cost treatment options with much-needed involvement of health professionals in this type of patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02817724 (date of registration: 22/06/2016). BioMed Central 2016-11-25 /pmc/articles/PMC5124301/ /pubmed/27887610 http://dx.doi.org/10.1186/s12911-016-0394-0 Text en © The Author(s). 2016 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
Lozano-Lozano, Mario
Martín-Martín, Lydia
Galiano-Castillo, Noelia
Álvarez-Salvago, Francisco
Cantarero-Villanueva, Irene
Fernández-Lao, Carolina
Sánchez-Salado, Carmen
Arroyo-Morales, Manuel
Integral strategy to supportive care in breast cancer survivors through occupational therapy and a m-health system: design of a randomized clinical trial
title Integral strategy to supportive care in breast cancer survivors through occupational therapy and a m-health system: design of a randomized clinical trial
title_full Integral strategy to supportive care in breast cancer survivors through occupational therapy and a m-health system: design of a randomized clinical trial
title_fullStr Integral strategy to supportive care in breast cancer survivors through occupational therapy and a m-health system: design of a randomized clinical trial
title_full_unstemmed Integral strategy to supportive care in breast cancer survivors through occupational therapy and a m-health system: design of a randomized clinical trial
title_short Integral strategy to supportive care in breast cancer survivors through occupational therapy and a m-health system: design of a randomized clinical trial
title_sort integral strategy to supportive care in breast cancer survivors through occupational therapy and a m-health system: design of a randomized clinical trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5124301/
https://www.ncbi.nlm.nih.gov/pubmed/27887610
http://dx.doi.org/10.1186/s12911-016-0394-0
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