title: Integral strategy to supportive care in breast cancer survivors through occupational therapy and a m-health system: design of a randomized clinical trial.
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: NCT02817724 (date of registration: 22/06/2016).
authors.affiliation: Department Physical Therapy, University of Granada, Granada, Spain.|Mixed University Sport and Health Institute (iMUDS), Granada, Spain.
authors.forename: Mario
authors.initials: M
authors.lastname: Lozano-Lozano
authors.affiliation: Department Physical Therapy, University of Granada, Granada, Spain.
authors.forename: Lydia
authors.initials: L
authors.lastname: Martín-Martín
authors.affiliation: Department Physical Therapy, University of Granada, Granada, Spain.|Institute for Biomedical Research ibs.GRANADA, University Hospital Complex of Granada/ University of Granada, Granada, Spain.
authors.forename: Noelia
authors.initials: N
authors.lastname: Galiano-Castillo
authors.affiliation: Department Physical Therapy, University of Granada, Granada, Spain.
authors.forename: Francisco
authors.initials: F
authors.lastname: Álvarez-Salvago
authors.affiliation: Department Physical Therapy, University of Granada, Granada, Spain.|Mixed University Sport and Health Institute (iMUDS), Granada, Spain.|Institute for Biomedical Research ibs.GRANADA, University Hospital Complex of Granada/ University of Granada, Granada, Spain.
authors.forename: Irene
authors.initials: I
authors.lastname: Cantarero-Villanueva
authors.affiliation: Department Physical Therapy, University of Granada, Granada, Spain.|Mixed University Sport and Health Institute (iMUDS), Granada, Spain.|Institute for Biomedical Research ibs.GRANADA, University Hospital Complex of Granada/ University of Granada, Granada, Spain.
authors.forename: Carolina
authors.initials: C
authors.lastname: Fernández-Lao
authors.affiliation: Breast Oncology Unit, Virgen de las Nieves Hospital, Granada, Spain.
authors.forename: Carmen
authors.initials: C
authors.lastname: Sánchez-Salado
authors.affiliation: Department Physical Therapy, University of Granada, Granada, Spain. marroyo@ugr.es.|Mixed University Sport and Health Institute (iMUDS), Granada, Spain. marroyo@ugr.es.|Institute for Biomedical Research ibs.GRANADA, University Hospital Complex of Granada/ University of Granada, Granada, Spain. marroyo@ugr.es.
authors.forename: Manuel
authors.initials: M
authors.lastname: Arroyo-Morales
mesh_terms: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000534:rehabilitation*; D005260:Female; D006801:Humans; D008875:Middle Aged; D009788:Occupational Therapy / Q000379:methods*; D017741:Survivors; D017216:Telemedicine / Q000379:methods*
keywords: Breast; Mobile applications; Neoplasms; Occupational therapy; Quality of life