Integral Strategy to Supportive Care in Breast Cancer Patients
2 other identifiers
interventional
80
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2016
CompletedFirst Posted
Study publicly available on registry
June 29, 2016
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedOctober 25, 2017
October 1, 2017
1.4 years
June 22, 2016
October 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of life (QLQ)
The primary outcome will be assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORT QLQ-C30) version 3.0., and with the European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire (EORT QLQ-BR23). Both are the most widely used instruments to measure Quality of Life in cancer patients.
Participants will be followed over 8 weeks.
Secondary Outcomes (11)
Body mass Index
Participants will be followed over 8 weeks.
Fat mass
Participants will be followed over 8 weeks.
Abdominal adipose tissue
Participants will be followed over 8 weeks.
Bone mineral density
Participants will be followed over 8 weeks.
Shoulder Range of Motion (ROM)
Participants will be followed over 8 weeks.
- +6 more secondary outcomes
Study Arms (2)
m-Health group
ACTIVE COMPARATORBENECA System: The m-health group will use the BENECA app for 8 weeks.
Integral Group
EXPERIMENTALBENECA 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.
Interventions
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).
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
You may qualify if:
- Diagnosis of stage I, II or IIIA breast cancer.
- 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.
You may not qualify if:
- History of cancer recurrence.
- Chronic disease or orthopedic issues that would interfere with the ability to participate in the rehabilitation program.
- Uncontrolled hypertension (diastolic pressure \> 95mm Hg).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universidad de Granadalead
- Carlos III Health Institutecollaborator
Study Sites (1)
Faculty of Health Sciences. University of Granada
Granada, 18071, Spain
Related Publications (2)
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.
PMID: 29588273DERIVEDLozano-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.
PMID: 27887610DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Manuel Arroyo-Morales, PhD
Deparment of physiotherapy, Faculty of Health Sciences, University of Granada
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
June 22, 2016
First Posted
June 29, 2016
Study Start
July 1, 2016
Primary Completion
December 1, 2017
Study Completion
July 1, 2019
Last Updated
October 25, 2017
Record last verified: 2017-10