Breast Cancere-CUIDACHEMONCT02350582
e-CUIDACHEMO: Telerehabilitation During Chemotherapy in Breast Cancer
A study testing Telerehabilitation eCUIDATE system in people with Breast Cancer, run by Universidad de Granada at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Telerehabilitation eCUIDATE system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2012to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Chronic disease or orthopedic issues that would interfere with ability to participate in a physical activity program;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
The CUIDATE group will identify impairments of participants at baseline assessment. The aims based on weekly improvements will be set to facilitate the final goal. After each training session there will be feedback between the participant and the CUIDATE group to change or improve any exercise or activity. This feedback will allow to us to select adequate exercises and levels of difficulty. As a result, a modifiable personal training will be assigned to each one focusing on cardio-respiratory, mobility, and endurance performance through online system rehabilitation (using written instructions, HD videos, and audio files).
- Conditions
- Breast Cancer
- Being tested
- Telerehabilitation eCUIDATE system
- Keywords
- breast cancer, telerehabilitation, strength, fatigue, quality of life
- Medical subject headings
- Breast Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation eCUIDATE systemDevice
Resistence and endurance exercise adapted to individual requeriment during chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation | Experimental | Resistence and endurance exercise adapted to individual requeriment using internet to monitor progression during chemotherapy treatment. Telerehabilitation eCUIDATE system Receives: Device: Telerehabilitation eCUIDATE system |
| Control group | No intervention | usual care offered to patients during chemotherapy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory capacity
Distance in meters in 6 minutes walking test
Measured: 1 day
Secondary outcomes (6)
Abdominal endurance strength
Abdominal resistance using curl-up test
Measured: 1 day
Lumbar extensor endurance strength
Lumbar extensor strength using dynamometer
Measured: 1 day
Handgrip endurance strength
Handgrip endurance using isometric dynamometer
Measured: 1 day
Cancer related fatigue
Piper Fatigue Scale
Measured: 2 days
Cancer related pain
Brief Pain Inventory
Measured: 2 days
Cancer related quality of life
EORTC Quality of life questionaire Core and Br23
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study startApr 2012
- Primary completionJun 2015
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Collaborators
- Andalusian Health Service
- Responsible party
- Principal investigator, Manuel Arroyo Morales, Universidad de Granada
- Investigators
- Manuel Arroyo-Morales, PhD, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02350582
- Sponsor's protocol ID
- SAS-0457-2010
- Acronym
- e-CUIDACHEMO
- Status last verified
- Jul 2017
- First submitted
- 26 Jan 2015
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Ariza-Garcia A, Lozano-Lozano M, Galiano-Castillo N, Postigo-Martin P, Arroyo-Morales M, Cantarero-Villanueva I. A Web-Based Exercise System (e-CuidateChemo) to Counter the Side Effects of Chemotherapy in Patients With Breast Cancer: Randomized Controlled Trial. J Med Internet Res. 2019 Jul 24;21(7):e14418. doi: 10.2196/14418.
PubMed 31342907
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- e-CUIDACHEMO: Telerehabilitation During Chemotherapy in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT02350582
- Acronym / sponsor ID
- e-CUIDACHEMO / SAS-0457-2010
- Conditions
- Breast Cancer
- Keywords
- breast cancer, telerehabilitation, strength, fatigue, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Collaborators
- Andalusian Health Service
- Study start
- Apr 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 29 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The CUIDATE group will identify impairments of participants at baseline assessment. The aims based on weekly improvements will be set to facilitate the final goal. After each training session there will be feedback between the participant and the CUIDATE group to change or improve any exercise or activity. This feedback will allow to us to select adequate exercises and levels of difficulty. As a result, a modifiable personal training will be assigned to each one focusing on cardio-respiratory, mobility, and endurance performance through online system rehabilitation (using written instructions, HD videos, and audio files).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation | Experimental | Device: Telerehabilitation eCUIDATE systemResistence and endurance exercise adapted to individual requeriment using internet to monitor progression during chemotherapy treatment. Telerehabilitation eCUIDATE system |
| Control group | No intervention | –usual care offered to patients during chemotherapy treatment |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (1 listed)
- Chronic disease or orthopedic issues that would interfere with ability to participate in a physical activity program;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telerehabilitation eCUIDATE systemResistence and endurance exercise adapted to individual requeriment during chemotherapy | Device | Telerehabilitation |
Primary outcome
Cardiorespiratory capacity
Time frame: 1 day
Distance in meters in 6 minutes walking test
6 secondary outcomes
Abdominal endurance strength
Time frame: 1 day
Lumbar extensor endurance strength
Time frame: 1 day
Handgrip endurance strength
Time frame: 1 day
Cancer related fatigue
Time frame: 2 days
Cancer related pain
Time frame: 2 days
Cancer related quality of life
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
- Derived from this study: PubMed 31342907Ariza-Garcia A, Lozano-Lozano M, Galiano-Castillo N, Postigo-Martin P, Arroyo-Morales M, Cantarero-Villanueva I. A Web-Based Exercise System (e-CuidateChemo) to Counter the Side Effects of Chemotherapy in Patients With Breast Cancer: Randomized Controlled Trial. J Med Internet Res. 2019 Jul 24;21(7):e14418. doi: 10.2196/14418.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel Arroyo-Morales, PhD principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation eCUIDATE system in people with Breast Cancer, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory capacity (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02350582, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2017.