Breast CancerNCT01801527
Telehealth System to Improve Quality of Life in Breast Cancer Survivors
A study testing Telerehabilitation group in people with Breast Cancer, run by Universidad de Granada at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Telerehabilitation group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2012to Jul 2014
- 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 18 to 65 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
- 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
Show all 9Show fewer
- No history of cancer recurrence
- Have interest in improving lifestyle: fitness/stress level
- Have signed informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Breast Cancer
- Being tested
- Telerehabilitation group
- Keywords
- Telehealth, Fatigue, Breast cancer, Exercise, Quality of life, Telerehabilitation
- Medical subject headings
- Breast Neoplasms, Fatigue, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation groupBehavioural
Interventions will be based on to provide cardiovascular, mobility, strength and stretching exercises through telerehabilitation system
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation group | Experimental | Not described Receives: Behavioral: Telerehabilitation group |
| Control group | No intervention | Information about usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
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
Measured: Participants will be followed over 8 weeks
Secondary outcomes (10)
Algometry
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
Measured: Participants will be followed over 8 weeks
The Visual Analogue Scale (VAS) for pain
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
Measured: Participants will be followed over 8 weeks
Pain
The Brief Pain Inventory (BPI) short form will be used to assess pain severity and pain interference
Measured: Participants will be followed over 8 weeks
Body composition
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)
Measured: Participants will be followed over 8 weeks
Physical measurement
- The Abdominal test (McQuade)
- Measurement of upper body muscular strength: Handgrip strength will be determined using digital dynamometer (TKK 5101 Grip-D; Takey, Tokyo, Japan)
- Measurement of back muscle strength: Back muscle strength will be assessed with digital dynamometer (TKK 5002 Back-A; Takey, Tokyo, Japan)
- Lower body endurance: Multiple sit-to-stand test will be used to assess general lower extremity endurance
Measured: Participants will be followed over 8 weeks
Cardiorespiratory fitness
- The International Fitness Scale (IFIS) will be used to evaluate perceived patients' overall fitness, cardio-respiratory fitness, muscular fitness, speed-agility and flexibility
- Functional capacity: The 6-minute walk test using a treadmill (H-P-COSMOS for graphics; Germany) will be used to determine the maximum distance (meters) that can be walked in 6 min
Measured: Participants will be followed over 8 weeks
Fatigue
The Piper Fatigue Scale-revised (R-PFS) includes 22 items and four dimensions such as behavioral/severity, affective meaning, sensory and cognitive/mood
Measured: Participants will be followed over 8 weeks
Anxiety and depression
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
Measured: Participants will be followed over 8 weeks
Cognitive function
- The Trail Making Test (TMT) will be used to assess speed for attention, sequencing, mental flexibility, visual search and motor function. The TMT consists of two parts (A and B)
- The Auditory Consonant Trigram (ACT) will be used to test short-term memory, divided attention and information-processing capacity in adults
Measured: Participants will be followed over 8 weeks
Accelerometry
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
Measured: Participants will be followed over 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2013 (estimated)
- Study startMar 2012
- Primary completionFeb 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Collaborators
- Carlos III Health Institute
- Responsible party
- Principal investigator, Manuel Arroyo Morales, Universidad de Granada
- Investigators
- Manuel Arroyo-Morales, PhD, Principal investigator, Faculty of Health Sciences. University of Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01801527
- Sponsor's protocol ID
- PI10/02749-02764
- Status last verified
- Oct 2017
- First submitted
- 27 Feb 2013
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 28117498Galiano-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.
PubMed 23799886
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E-Cuidate: Effectiveness of a Telerehabilitation System in Women Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT01801527
- Acronym / sponsor ID
- PI10/02749-02764
- Conditions
- Breast Cancer
- Keywords
- Telehealth, Fatigue, Breast cancer, Exercise, Quality of life, Telerehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Collaborators
- Carlos III Health Institute
- Study start
- Mar 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 28 Feb 2013 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation group | Experimental | Behavioral: Telerehabilitation group |
| Control group | No intervention | –Information about usual care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (0 listed)
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 groupInterventions will be based on to provide cardiovascular, mobility, strength and stretching exercises through telerehabilitation system | Behavioural | Telerehabilitation group |
Primary outcome
Quality of life
Time frame: Participants will be followed over 8 weeks
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
10 secondary outcomes
Algometry
Time frame: Participants will be followed over 8 weeks
The Visual Analogue Scale (VAS) for pain
Time frame: Participants will be followed over 8 weeks
Pain
Time frame: Participants will be followed over 8 weeks
Body composition
Time frame: Participants will be followed over 8 weeks
Physical measurement
Time frame: Participants will be followed over 8 weeks
Cardiorespiratory fitness
Time frame: Participants will be followed over 8 weeks
Fatigue
Time frame: Participants will be followed over 8 weeks
Anxiety and depression
Time frame: Participants will be followed over 8 weeks
Cognitive function
Time frame: Participants will be followed over 8 weeks
Accelerometry
Time frame: Participants will be followed over 8 weeks
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 27 Oct 2017.
- Derived from this study: PubMed 28117498Galiano-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.
- Derived from this study: PubMed 23799886Galiano-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.
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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
Faculty of Health Sciences. University of 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 group 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 9 inclusion and 0 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 27 Oct 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?
Quality of life (time frame: Participants will be followed over 8 weeks). 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 NCT01801527, which also lists 2 linked publications.
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 27 Oct 2017.