- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01801527
Telehealth System to Improve Quality of Life in Breast Cancer Survivors
E-Cuidate: Effectiveness of a Telerehabilitation System in Women Breast Cancer Survivors
Background: Cancer is increasingly viewed as a chronic disease and therefore there is a growing need for long-term treatments. Breast cancer survivors suffer physical impairment after oncology treatment. This impairment reduces quality of life (QoL) and increases the prevalence of conditions associated to unhealthy life-style.
Objective: The overall objective of e-Cuidate telerehabilitation will be to evaluate short and long-term effects telehealth program.
Methods: Seventy-two breast cancer survivors (age range: 18-65 years) will be recruited through oncology and breast units at the Virgen de las Nieves Hospital and San Cecilio Hospital and associations of breast cancer patients in Granada. Patients will be randomized to receive the online rehabilitation group (n=36) or usual care (control) group (n=36). Telerehabilitation group will receive an eight-week online intervention and control group receive recommendations about usual care.
Discussion: The investigators study attempts to increase the level of fitness and reduce musculoskeletal disorders in breast cancer patients through a strategy for care based on telerehabilitation to promote therapeutic exercise.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Granada, Spain, 18071
- Faculty of health Sciences. University of Granada
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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
- Without chronic disease or orthopaedic that would interfere with ability to participate in a physical activity program
- Access to Internet
- Basic ability to use the computer or living with a relative who has this ability
- Completion of adjuvant therapy except for hormone therapy
- No history of cancer recurrence
- Have interest in improving lifestyle: fitness/stress level
- Have signed informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Telerehabilitation group
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Interventions will be based on to provide cardiovascular, mobility, strength and stretching exercises through telerehabilitation system
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No Intervention: Control group
Information about usual care
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life
Time Frame: Participants will be followed over 8 weeks
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The primary outcome will be assessed with The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0.
This questionnaire includes both multi-item scales and single-item measures.
These are composed by five functional scales, three symptom scales, a global health status/QoL scale, and six single items.
The scores have to be averaged and transformed linearly to obtain a range of score from 0 to 100 where high score meaning a great response level.
The European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23) which is a breast cancer module of EORTC QLQ-C30 will also be assessed
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Participants will be followed over 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Algometry
Time Frame: Participants will be followed over 8 weeks
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The pressure pain thresholds (PPTs) will be measured through an electronic algometer (Somedic AB, Farsta, Sweden).
PPTs over the C5-C6 zygapophyseal joint, deltoid muscle and tibialis anterior muscle will be assessed bilaterally.
The mean of 3 trials will be used for the main analysis
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Participants will be followed over 8 weeks
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The Visual Analogue Scale (VAS) for pain
Time Frame: Participants will be followed over 8 weeks
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This is a scale for subjective pain estimation that consists of line with a range scored of 0-10 where 0 means 'no pain' and 10 means 'worst pain imaginable'.
Participants will have to mark of level of pain that they feel in that moment for both upper limb
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Participants will be followed over 8 weeks
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Pain
Time Frame: Participants will be followed over 8 weeks
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The Brief Pain Inventory (BPI) short form will be used to assess pain severity and pain interference
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Participants will be followed over 8 weeks
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Body composition
Time Frame: Participants will be followed over 8 weeks
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Height will be measured.
Weight, body mass index, skeletal muscle mass and percentage of body fat will be obtained with bioelectrical impedance analysis (InBody 720; Biospace, Seoul, South Korea)
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Participants will be followed over 8 weeks
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Physical measurement
Time Frame: Participants will be followed over 8 weeks
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Participants will be followed over 8 weeks
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Cardiorespiratory fitness
Time Frame: Participants will be followed over 8 weeks
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Participants will be followed over 8 weeks
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Fatigue
Time Frame: Participants will be followed over 8 weeks
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The Piper Fatigue Scale-revised (R-PFS) includes 22 items and four dimensions such as behavioral/severity, affective meaning, sensory and cognitive/mood
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Participants will be followed over 8 weeks
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Anxiety and depression
Time Frame: Participants will be followed over 8 weeks
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The Hospital Anxiety and Depression Scale (HADS) will be used to assess levels of anxiety and depression.
It contains 14 items (7 items for each scale) with 4-point Likert scale
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Participants will be followed over 8 weeks
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Cognitive function
Time Frame: Participants will be followed over 8 weeks
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Participants will be followed over 8 weeks
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Accelerometry
Time Frame: Participants will be followed over 8 weeks
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Participants will be asked to wear an tri-axial accelerometer (ActiGraph GT3X+, Pensacola, Florida, US) for 8 consecutive days, starting the same day they receive the monitor, and will returned the accelerometers to the researcher 9 days later
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Participants will be followed over 8 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Manuel Arroyo-Morales, PhD, Faculty of health Sciences. University of Granada
Publications and helpful links
General Publications
- Galiano-Castillo N, Arroyo-Morales M, Ariza-Garcia A, Fernandez-Lao C, Fernandez-Fernandez AJ, Cantarero-Villanueva I. Factors that Explain the Cancer-Related Insomnia. Breast J. 2017 Jul;23(4):387-394. doi: 10.1111/tbj.12759. Epub 2017 Jan 24.
- Galiano-Castillo N, Ariza-Garcia A, Cantarero-Villanueva I, Fernandez-Lao C, Diaz-Rodriguez L, Legeren-Alvarez M, Sanchez-Salado C, Del-Moral-Avila R, Arroyo-Morales M. Telehealth system (e-CUIDATE) to improve quality of life in breast cancer survivors: rationale and study protocol for a randomized clinical trial. Trials. 2013 Jun 22;14:187. doi: 10.1186/1745-6215-14-187.
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
- PI10/02749-02764
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.
Clinical Trials on Breast Cancer
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Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
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Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
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University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
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Baylor Breast Care CenterRecruitingBreast Cancer | Breast Neoplasm | Triple Negative Breast Cancer | Triple Negative Breast Neoplasms | HER2-positive Breast Cancer | Breast Cancer Stage II | Breast Cancer Female | Breast Cancer Stage III | Estrogen Receptor-positive Breast Cancer | Hormone Receptor-positive Breast Cancer | Breast Cancer InvasiveUnited States
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Innocrin PharmaceuticalCompletedBreast Cancer | Advanced Breast Cancer | Metastatic Breast Cancer | Triple Negative Breast Cancer | Male Breast Cancer | ER+ Breast Cancer | Cancer of the BreastUnited States
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University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
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CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
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University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
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University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
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University of Southern CaliforniaNational Cancer Institute (NCI)WithdrawnStage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer
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