Integral Strategy to Supportive Care in Breast Cancer Patients
NCT ID: NCT02817724
Last Updated: 2017-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2016-07-31
2019-07-31
Brief Summary
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Detailed Description
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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) and will receive a supervised rehabilitation (8-weeks); m-health group will use the BENECA app for 8-weeks. Study endpoints will be assessed after 8 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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m-Health group
BENECA System: The m-health group will use the BENECA app for 8 weeks.
BENECA System
BENECA System is a mobile application whit aims to recover a healthy lifestyle in breast cancer survivors (in terms of energy balance: physical activity and dietary).
Integral Group
BENECA System and Supervised-occupational therapy program: The integral groups will use the BENECA app and they will receive a face-to-face occupational therapy rehabilitation program for 8 weeks.
BENECA System
BENECA System is a mobile application whit aims to recover a healthy lifestyle in breast cancer survivors (in terms of energy balance: physical activity and dietary).
Supervised-occupational therapy program
It is a comprehensive program that covers most of the physical, cognitive and emotional needs of these patients after oncology treatment from occupational therapy perspective.
Interventions
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BENECA System
BENECA System is a mobile application whit aims to recover a healthy lifestyle in breast cancer survivors (in terms of energy balance: physical activity and dietary).
Supervised-occupational therapy program
It is a comprehensive program that covers most of the physical, cognitive and emotional needs of these patients after oncology treatment from occupational therapy perspective.
Eligibility Criteria
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Inclusion Criteria
* Overweight or obese, according to the Spanish Society for the Study of Obesity.
* Basic ability to use mobile apps or living with someone who has this ability.
* Medical clearance of participants.
* Completion of adjuvant therapy except for hormone therapy.
* Some functional or Range of Motion (ROM) limitations measures by goniometry and the DASH Questionnaire.
* Have signed informed consent.
Exclusion Criteria
* Chronic disease or orthopedic issues that would interfere with the ability to participate in the rehabilitation program.
* Uncontrolled hypertension (diastolic pressure \> 95mm Hg).
25 Years
75 Years
FEMALE
No
Sponsors
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Carlos III Health Institute
OTHER_GOV
Universidad de Granada
OTHER
Responsible Party
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Manuel Arroyo Morales
PhD
Principal Investigators
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Manuel Arroyo-Morales, PhD
Role: STUDY_DIRECTOR
Deparment of physiotherapy, Faculty of Health Sciences, University of Granada
Locations
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Faculty of Health Sciences. University of Granada
Granada, , Spain
Countries
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References
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Lozano-Lozano M, Galiano-Castillo N, Martin-Martin L, Pace-Bedetti N, Fernandez-Lao C, Arroyo-Morales M, Cantarero-Villanueva I. Monitoring Energy Balance in Breast Cancer Survivors Using a Mobile App: Reliability Study. JMIR Mhealth Uhealth. 2018 Mar 27;6(3):e67. doi: 10.2196/mhealth.9669.
Lozano-Lozano M, Martin-Martin L, Galiano-Castillo N, Alvarez-Salvago F, Cantarero-Villanueva I, Fernandez-Lao C, Sanchez-Salado C, Arroyo-Morales M. Integral strategy to supportive care in breast cancer survivors through occupational therapy and a m-health system: design of a randomized clinical trial. BMC Med Inform Decis Mak. 2016 Nov 25;16(1):150. doi: 10.1186/s12911-016-0394-0.
Other Identifiers
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PI14/01627
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
FPU14/01069
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
PI14/01627
Identifier Type: -
Identifier Source: org_study_id