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The purpose of this study is to determine if it is better an integral strategy, with a m-health system, when used in addition to a supervised treatment, versus the use of the m-health system alone, to improve the immediate and long-term Quality of Life of breast cancer survivors.
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 (QoL) in breast cancer survivors.
Methods: This therapeutic superiority study will use a two-arm, assessor blinded parallel randomized clinical trial (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 > 25kg/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) (6-weeks) and will receive a supervised rehabilitation (8-weeks); m-health group will use the BENECA app for 14-weeks. Study endpoints will be assessed after 14 weeks and 24 weeks. The primary outcome will be QoL 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, Trial Making Test); anxiety and depression (Hospital Anxiety and Depression Scale); and accelerometer.
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
BENECA System, Supervised-occupational therapy program
Faculty of Health Sciences. University of Granada
Not yet recruiting
Universidad de Granada
Published on BioPortfolio: 2016-06-29T20:53:21-0400
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Breast neoplasms that do not express ESTROGEN RECEPTORS; PROGESTERONE RECEPTORS; and do not overexpress the NEU RECEPTOR/HER-2 PROTO-ONCOGENE PROTEIN.
Any neoplasms of the male breast. These occur infrequently in males in developed countries, the incidence being about 1% of that in females.
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Metastatic breast cancer characterized by EDEMA and ERYTHEMA of the affected breast due to LYMPHATIC METASTASIS and eventual obstruction of LYMPHATIC VESSELS by the cancer cells.
Tumors or cancer of the human BREAST.
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