Breast Cancer
Conditions
Keywords
Telehealth, Fatigue, Breast cancer, Exercise, Quality of life, Telerehabilitation
Brief 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. 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.
Interventions
BEHAVIORALTelerehabilitation group
Interventions will be based on to provide cardiovascular, mobility, strength and stretching exercises through telerehabilitation system
Sponsors
Carlos III Health Institute
Universidad de Granada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Visual Analogue Scale (VAS) for pain | Participants will be followed over 8 weeks | 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 |
| Pain | Participants will be followed over 8 weeks | The Brief Pain Inventory (BPI) short form will be used to assess pain severity and pain interference |
| Body composition | Participants will be followed over 8 weeks | 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) |
| Physical measurement | Participants will be followed over 8 weeks | * 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 |
| Algometry | Participants will be followed over 8 weeks | 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 |
| Fatigue | Participants will be followed over 8 weeks | The Piper Fatigue Scale-revised (R-PFS) includes 22 items and four dimensions such as behavioral/severity, affective meaning, sensory and cognitive/mood |
| Anxiety and depression | Participants will be followed over 8 weeks | 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 |
| Cognitive function | Participants will be followed over 8 weeks | * 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 |
| Accelerometry | Participants will be followed over 8 weeks | 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 |
| Cardiorespiratory fitness | Participants will be followed over 8 weeks | * 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 |
Countries
Spain
Outcome results
None listed