Integral strategy to supportive care in breast cancer survivors through occupational therapy and a m-health system: design of a randomized clinical trial
Identifieur interne : 000F53 ( Main/Exploration ); précédent : 000F52; suivant : 000F54Integral strategy to supportive care in breast cancer survivors through occupational therapy and a m-health system: design of a randomized clinical trial
Auteurs : Mario Lozano-Lozano [Espagne] ; Lydia Martín-Martín [Espagne] ; Noelia Galiano-Castillo [Espagne] ; Francisco Álvarez-Salvago [Espagne] ; Irene Cantarero-Villanueva [Espagne] ; Carolina Fernández-Lao [Espagne] ; Carmen Sánchez-Salado [Espagne] ; Manuel Arroyo-Morales [Espagne]Source :
- BMC Medical Informatics and Decision Making [ 1472-6947 ] ; 2016.
Abstract
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.
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/m2; 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.
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.
ClinicalTrials.gov Identifier:
Url:
DOI: 10.1186/s12911-016-0394-0
PubMed: 27887610
PubMed Central: 5124301
Affiliations:
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Health Institute (iMUDS), Granada, Spain</nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Mixed University Sport and Health Institute (iMUDS), Granada</wicri:regionArea><wicri:noRegion>Granada</wicri:noRegion></affiliation></author><author><name sortKey="Martin Martin, Lydia" sort="Martin Martin, Lydia" uniqKey="Martin Martin L" first="Lydia" last="Martín-Martín">Lydia Martín-Martín</name><affiliation wicri:level="4"><nlm:aff id="Aff1">Department Physical Therapy, University of Granada, Granada, Spain</nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Department Physical Therapy, University of Granada, Granada</wicri:regionArea><orgName type="university">Université de Grenade</orgName><placeName><settlement type="city">Grenade (Espagne)</settlement><region nuts="2" type="region">Andalousie</region></placeName></affiliation></author><author><name sortKey="Galiano Castillo, Noelia" sort="Galiano Castillo, Noelia" uniqKey="Galiano Castillo N" first="Noelia" last="Galiano-Castillo">Noelia Galiano-Castillo</name><affiliation wicri:level="4"><nlm:aff id="Aff1">Department Physical Therapy, University of Granada, Granada, Spain</nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Department Physical Therapy, University of Granada, Granada</wicri:regionArea><orgName type="university">Université de Grenade</orgName><placeName><settlement type="city">Grenade (Espagne)</settlement><region nuts="2" type="region">Andalousie</region></placeName></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff3">Institute for Biomedical Research ibs.GRANADA, University Hospital Complex of Granada/ University of Granada, Granada, Spain</nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Institute for Biomedical Research ibs.GRANADA, University Hospital Complex of Granada/ University of Granada, Granada</wicri:regionArea><wicri:noRegion>Granada</wicri:noRegion></affiliation></author><author><name sortKey="Alvarez Salvago, Francisco" sort="Alvarez Salvago, Francisco" uniqKey="Alvarez Salvago F" first="Francisco" last="Álvarez-Salvago">Francisco Álvarez-Salvago</name><affiliation wicri:level="4"><nlm:aff id="Aff1">Department Physical Therapy, University of Granada, Granada, Spain</nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Department Physical Therapy, University of Granada, Granada</wicri:regionArea><orgName type="university">Université de Grenade</orgName><placeName><settlement type="city">Grenade (Espagne)</settlement><region nuts="2" type="region">Andalousie</region></placeName></affiliation></author><author><name sortKey="Cantarero Villanueva, Irene" sort="Cantarero Villanueva, Irene" uniqKey="Cantarero Villanueva I" first="Irene" last="Cantarero-Villanueva">Irene Cantarero-Villanueva</name><affiliation wicri:level="4"><nlm:aff id="Aff1">Department Physical Therapy, University of Granada, Granada, Spain</nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Department Physical Therapy, University of Granada, Granada</wicri:regionArea><orgName type="university">Université de Grenade</orgName><placeName><settlement type="city">Grenade (Espagne)</settlement><region nuts="2" type="region">Andalousie</region></placeName></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff2">Mixed University Sport and Health Institute (iMUDS), Granada, Spain</nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Mixed University Sport and Health Institute (iMUDS), Granada</wicri:regionArea><wicri:noRegion>Granada</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff3">Institute for Biomedical Research ibs.GRANADA, University Hospital Complex of Granada/ University of Granada, Granada, Spain</nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Institute for Biomedical Research ibs.GRANADA, University Hospital Complex of Granada/ University of Granada, Granada</wicri:regionArea><wicri:noRegion>Granada</wicri:noRegion></affiliation></author><author><name sortKey="Fernandez Lao, Carolina" sort="Fernandez Lao, Carolina" uniqKey="Fernandez Lao C" first="Carolina" last="Fernández-Lao">Carolina Fernández-Lao</name><affiliation wicri:level="4"><nlm:aff id="Aff1">Department Physical Therapy, University of Granada, Granada, Spain</nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Department Physical Therapy, University of Granada, Granada</wicri:regionArea><orgName type="university">Université de Grenade</orgName><placeName><settlement type="city">Grenade (Espagne)</settlement><region nuts="2" type="region">Andalousie</region></placeName></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff2">Mixed University Sport and Health Institute (iMUDS), Granada, Spain</nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Mixed University Sport and Health Institute (iMUDS), Granada</wicri:regionArea><wicri:noRegion>Granada</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff3">Institute for Biomedical Research ibs.GRANADA, University Hospital Complex of Granada/ University of Granada, Granada, Spain</nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Institute for Biomedical Research ibs.GRANADA, University Hospital Complex of Granada/ University of Granada, Granada</wicri:regionArea><wicri:noRegion>Granada</wicri:noRegion></affiliation></author><author><name sortKey="Sanchez Salado, Carmen" sort="Sanchez Salado, Carmen" uniqKey="Sanchez Salado C" first="Carmen" last="Sánchez-Salado">Carmen Sánchez-Salado</name><affiliation wicri:level="1"><nlm:aff id="Aff4">Breast Oncology Unit, Virgen de las Nieves Hospital, Granada, Spain</nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Breast Oncology Unit, Virgen de las Nieves Hospital, Granada</wicri:regionArea><wicri:noRegion>Granada</wicri:noRegion></affiliation></author><author><name sortKey="Arroyo Morales, Manuel" sort="Arroyo Morales, Manuel" uniqKey="Arroyo Morales M" first="Manuel" last="Arroyo-Morales">Manuel Arroyo-Morales</name><affiliation wicri:level="4"><nlm:aff id="Aff1">Department Physical Therapy, University of Granada, Granada, Spain</nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Department Physical Therapy, University of Granada, Granada</wicri:regionArea><orgName type="university">Université de Grenade</orgName><placeName><settlement type="city">Grenade (Espagne)</settlement><region nuts="2" type="region">Andalousie</region></placeName></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff2">Mixed University Sport and Health Institute (iMUDS), Granada, Spain</nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Mixed University Sport and Health Institute (iMUDS), Granada</wicri:regionArea><wicri:noRegion>Granada</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff3">Institute for Biomedical Research ibs.GRANADA, University Hospital Complex of Granada/ University of Granada, Granada, Spain</nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Institute for Biomedical Research ibs.GRANADA, University Hospital Complex of Granada/ University of Granada, Granada</wicri:regionArea><wicri:noRegion>Granada</wicri:noRegion></affiliation></author></analytic><series><title level="j">BMC Medical Informatics and Decision Making</title><idno type="eISSN">1472-6947</idno><imprint><date when="2016">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>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.</p></sec><sec><title>Methods</title><p>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<sup>2</sup>; 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.</p></sec><sec><title>Discussion</title><p>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.</p></sec><sec><title>Trial registration</title><p>ClinicalTrials.gov Identifier: <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT02817724?term=NCT02817724&rank=1">NCT02817724</ext-link> (date of registration: 22/06/2016).</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Bray, F" uniqKey="Bray F">F Bray</name></author><author><name sortKey="Jemal, A" uniqKey="Jemal A">A Jemal</name></author><author><name sortKey="Torre, La" uniqKey="Torre L">LA Torre</name></author><author><name sortKey="Forman, D" uniqKey="Forman D">D Forman</name></author><author><name sortKey="Vineis, P" uniqKey="Vineis P">P Vineis</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Smith, Sl" uniqKey="Smith S">SL Smith</name></author><author><name sortKey="Singh Carlson, S" uniqKey="Singh Carlson S">S Singh-Carlson</name></author><author><name sortKey="Downie, L" uniqKey="Downie L">L Downie</name></author><author><name sortKey="Payeur, N" uniqKey="Payeur N">N Payeur</name></author><author><name sortKey="Wai, Es" uniqKey="Wai E">ES 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FitzerGerald</name></author><author><name sortKey="Gregg, Ew" uniqKey="Gregg E">EW Gregg</name></author><author><name sortKey="Joswiak, Ml" uniqKey="Joswiak M">ML Joswiak</name></author><author><name sortKey="Ryan, Wj" uniqKey="Ryan W">WJ Ryan</name></author><author><name sortKey="Suminski, Rr" uniqKey="Suminski R">RR Suminski</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Fernandez Cabrera, T" uniqKey="Fernandez Cabrera T">T Fernández Cabrera</name></author><author><name sortKey="Medina Anzano, S" uniqKey="Medina Anzano S">S Medina Anzano</name></author><author><name sortKey="Maria Herrera Sanchez, I" uniqKey="Maria Herrera Sanchez I">I María Herrera Sánchez</name></author><author><name sortKey="Rueda Mendez, S" uniqKey="Rueda Mendez S">S Rueda Méndez</name></author><author><name sortKey="Fernandez Del Olmo, A" uniqKey="Fernandez Del Olmo A">A Fernández Del 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O">O Ung</name></author><author><name sortKey="Boyages, J" uniqKey="Boyages J">J Boyages</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Osoba, D" uniqKey="Osoba D">D Osoba</name></author><author><name sortKey="Rodrigues, G" uniqKey="Rodrigues G">G Rodrigues</name></author><author><name sortKey="Myles, J" uniqKey="Myles J">J Myles</name></author><author><name sortKey="Zee, B" uniqKey="Zee B">B Zee</name></author><author><name sortKey="Pater, J" uniqKey="Pater J">J Pater</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Schmitz, Kh" uniqKey="Schmitz K">KH Schmitz</name></author><author><name sortKey="Courneya, Ks" uniqKey="Courneya K">KS Courneya</name></author><author><name sortKey="Matthews, C" uniqKey="Matthews C">C Matthews</name></author><author><name sortKey="Demark Wahnefried, W" uniqKey="Demark Wahnefried W">W Demark-Wahnefried</name></author><author><name sortKey="Galvao, D A" uniqKey="Galvao D">D a Galvão</name></author><author><name sortKey="Pinto, Bm" uniqKey="Pinto B">BM Pinto</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Demark Wahnefried, W" uniqKey="Demark Wahnefried W">W Demark-wahnefried</name></author><author><name sortKey="Bandera, Ev" uniqKey="Bandera E">EV Bandera</name></author><author><name sortKey="Gapstur, S" uniqKey="Gapstur S">S Gapstur</name></author><author><name sortKey="Patel, Av" uniqKey="Patel A">AV Patel</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Baili, P" uniqKey="Baili P">P Baili</name></author><author><name sortKey="Hoekstra Weebers, J" uniqKey="Hoekstra Weebers J">J Hoekstra-Weebers</name></author><author><name sortKey="Van Hoof, E" uniqKey="Van Hoof E">E Van Hoof</name></author><author><name sortKey="Bartsch, Hh" uniqKey="Bartsch H">HH Bartsch</name></author><author><name sortKey="Travado, L" uniqKey="Travado L">L Travado</name></author><author><name sortKey="Garami, M" uniqKey="Garami M">M Garami</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Gatta, G" uniqKey="Gatta G">G Gatta</name></author><author><name sortKey="Van Der Zwan, Jm" uniqKey="Van Der Zwan J">JM Van Der Zwan</name></author><author><name sortKey="Casali, Pg" uniqKey="Casali P">PG Casali</name></author><author><name sortKey="Siesling, S" uniqKey="Siesling S">S Siesling</name></author><author><name sortKey="Dei Tos, Ap" uniqKey="Dei Tos A">AP Dei Tos</name></author><author><name sortKey="Kunkler, I" uniqKey="Kunkler I">I Kunkler</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Espagne</li></country><region><li>Andalousie</li></region><settlement><li>Grenade (Espagne)</li></settlement><orgName><li>Université de Grenade</li></orgName></list><tree><country name="Espagne"><region name="Andalousie"><name sortKey="Lozano Lozano, Mario" sort="Lozano Lozano, Mario" uniqKey="Lozano Lozano M" first="Mario" last="Lozano-Lozano">Mario Lozano-Lozano</name></region><name sortKey="Alvarez Salvago, Francisco" sort="Alvarez Salvago, Francisco" uniqKey="Alvarez Salvago F" first="Francisco" last="Álvarez-Salvago">Francisco Álvarez-Salvago</name><name sortKey="Arroyo Morales, Manuel" sort="Arroyo Morales, Manuel" uniqKey="Arroyo Morales M" first="Manuel" last="Arroyo-Morales">Manuel Arroyo-Morales</name><name sortKey="Arroyo Morales, Manuel" sort="Arroyo Morales, Manuel" uniqKey="Arroyo Morales M" first="Manuel" last="Arroyo-Morales">Manuel Arroyo-Morales</name><name sortKey="Arroyo Morales, Manuel" sort="Arroyo Morales, Manuel" uniqKey="Arroyo Morales M" first="Manuel" last="Arroyo-Morales">Manuel Arroyo-Morales</name><name sortKey="Cantarero Villanueva, Irene" sort="Cantarero Villanueva, Irene" uniqKey="Cantarero Villanueva I" first="Irene" last="Cantarero-Villanueva">Irene Cantarero-Villanueva</name><name sortKey="Cantarero Villanueva, Irene" sort="Cantarero Villanueva, Irene" uniqKey="Cantarero Villanueva I" first="Irene" last="Cantarero-Villanueva">Irene Cantarero-Villanueva</name><name sortKey="Cantarero Villanueva, Irene" sort="Cantarero Villanueva, Irene" uniqKey="Cantarero Villanueva I" first="Irene" last="Cantarero-Villanueva">Irene Cantarero-Villanueva</name><name sortKey="Fernandez Lao, Carolina" sort="Fernandez Lao, Carolina" uniqKey="Fernandez Lao C" first="Carolina" last="Fernández-Lao">Carolina Fernández-Lao</name><name sortKey="Fernandez Lao, Carolina" sort="Fernandez Lao, Carolina" uniqKey="Fernandez Lao C" first="Carolina" last="Fernández-Lao">Carolina Fernández-Lao</name><name sortKey="Fernandez Lao, Carolina" sort="Fernandez Lao, Carolina" uniqKey="Fernandez Lao C" first="Carolina" last="Fernández-Lao">Carolina Fernández-Lao</name><name sortKey="Galiano Castillo, Noelia" sort="Galiano Castillo, Noelia" uniqKey="Galiano Castillo N" first="Noelia" last="Galiano-Castillo">Noelia Galiano-Castillo</name><name sortKey="Galiano Castillo, Noelia" sort="Galiano Castillo, Noelia" uniqKey="Galiano Castillo N" first="Noelia" last="Galiano-Castillo">Noelia Galiano-Castillo</name><name sortKey="Lozano Lozano, Mario" sort="Lozano Lozano, Mario" uniqKey="Lozano Lozano M" first="Mario" last="Lozano-Lozano">Mario Lozano-Lozano</name><name sortKey="Martin Martin, Lydia" sort="Martin Martin, Lydia" uniqKey="Martin Martin L" first="Lydia" last="Martín-Martín">Lydia Martín-Martín</name><name sortKey="Sanchez Salado, Carmen" sort="Sanchez Salado, Carmen" uniqKey="Sanchez Salado C" first="Carmen" last="Sánchez-Salado">Carmen Sánchez-Salado</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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