Integral Strategy to Supportive Care in Breast Cancer Patients
Summary
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.
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 (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.
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Conditions
Breast Neoplasms
Intervention
BENECA System, Supervised-occupational therapy program
Location
Faculty of Health Sciences. University of Granada
Granada
Spain
18071
Status
Not yet recruiting
Source
Universidad de Granada
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT02817724
- ClinicalTrials.gov processed this data on June 28, 2016
Published on BioPortfolio: 2016-06-29T20:53:21-0400
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Medical and Biotech [MESH] Definitions
Triple Negative Breast Neoplasms
Breast neoplasms that do not express ESTROGEN RECEPTORS; PROGESTERONE RECEPTORS; and do not overexpress the NEU RECEPTOR/HER-2 PROTO-ONCOGENE PROTEIN.
Breast Neoplasms, Male
Any neoplasms of the male breast. These occur infrequently in males in developed countries, the incidence being about 1% of that in females.
Neoplasms, Ductal, Lobular, And Medullary
Neoplasms, usually carcinoma, located within the center of an organ or within small lobes, and in the case of the breast, intraductally. The emphasis of the name is on the location of the neoplastic tissue rather than on its histological type. Most cancers of this type are located in the breast.
Inflammatory Breast Neoplasms
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.
Breast Neoplasms
Tumors or cancer of the human BREAST.
