- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02350582
e-CUIDACHEMO: Telerehabilitation During Chemotherapy in Breast Cancer (e-CUIDACHEMO)
e-CUIDACHEMO: Telerehabilitation During Chemotherapy in Breast Cancer Patients
Patients with breast cancer undergo a series of psiclofisicas alterations during cancer treatment, chemotherapy phase being one of the more aggressive ete effect. These changes reduce the quality of life and result in a loss of physical health-related condition. Studies have shown that the practice of physical exercise and rehabilitation strategies enhance or attenuate the impact of chemotherapy on quality of life of patients. At present, technological development from telerehabilitación systems is a promising strategy that enables fast and efficient communication between health professionals and patients, especially at this stage of the disease where the patient may encounter difficulties in matching measures improving their lifestyle with aggressive medical treatment.
To carry out this study a controlled study masked, parallel-group done were conducted usual care control group and an intervention based on a web system telerehabilitación to improve the physical condition associated with health and performed quality of life.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Granada, Spain, 18071
- Faculty of health Sciences. University of Granada
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of stage I, II, or IIIA breast cancer
- Medical clearance of participation
- Access to the Internet
- Basic ability to use a computer or living with someone who has this ability
- In chemotherapy treatment at present moment;
- Have interest in improving lifestyle: fitness level
- Have signed informed consent
Exclusion Criteria:
- Chronic disease or orthopedic issues that would interfere with ability to participate in a physical activity program;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Telerehabilitation
Resistence and endurance exercise adapted to individual requeriment using internet to monitor progression during chemotherapy treatment.
Telerehabilitation eCUIDATE system
|
Resistence and endurance exercise adapted to individual requeriment during chemotherapy
|
No Intervention: Control group
usual care offered to patients during chemotherapy treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiorespiratory capacity
Time Frame: 1 day
|
Distance in meters in 6 minutes walking test
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Abdominal endurance strength
Time Frame: 1 day
|
Abdominal resistance using curl-up test
|
1 day
|
Lumbar extensor endurance strength
Time Frame: 1 day
|
Lumbar extensor strength using dynamometer
|
1 day
|
Handgrip endurance strength
Time Frame: 1 day
|
Handgrip endurance using isometric dynamometer
|
1 day
|
Cancer related fatigue
Time Frame: 2 days
|
Piper Fatigue Scale
|
2 days
|
Cancer related pain
Time Frame: 2 days
|
Brief Pain Inventory
|
2 days
|
Cancer related quality of life
Time Frame: 2 days
|
EORTC Quality of life questionaire Core and Br23
|
2 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Manuel Arroyo-Morales, PhD, Universidad de Granada
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SAS-0457-2010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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