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| Name | Class |
|---|---|
| Carlos III Health Institute | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telerehabilitation group | Experimental |
| |
| Control group | No Intervention | Information about usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telerehabilitation group | Behavioral | Interventions will be based on to provide cardiovascular, mobility, strength and stretching exercises through telerehabilitation system |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Participants will be followed over 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Participants will be followed over 8 weeks |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manuel Arroyo-Morales, PhD | Faculty of Health Sciences. University of Granada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Health Sciences. University of Granada | Granada | 18071 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28117498 | Derived | 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. | |
| 23799886 | Derived | 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D005221 | Fatigue |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 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 |
| 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 | 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) | Participants will be followed over 8 weeks |
| Physical measurement |
| Participants will be followed over 8 weeks |
| Cardiorespiratory fitness |
| 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 | 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 | Participants will be followed over 8 weeks |
| Cognitive function |
| 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 | Participants will be followed over 8 weeks |
| D017437 |
| Skin and Connective Tissue Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |