Telehealth System to Improve Quality of Life in Breast Cancer Survivors

Breast Cancer Clinical Trial

Official title:

E-Cuidate: Effectiveness of a Telerehabilitation System in Women Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01801527
• Other study ID #: PI10/02749-02764
• Status: Completed
• Phase: N/A
• First received: February 27, 2013
• Last updated: October 25, 2017
• Start date: March 2012
• Est. completion date: July 2014

Study information

• Verified date: October 2017
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Telerehabilitation group
Interventions will be based on to provide cardiovascular, mobility, strength and stretching exercises through telerehabilitation system

Locations

Country	Name	City	State
Spain	Faculty of Health Sciences. University of Granada	Granada

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Granada	Carlos III Health Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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	Participants will be followed over 8 weeks
Secondary	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	Participants will be followed over 8 weeks
Secondary	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
Secondary	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
Secondary	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	Participants will be followed over 8 weeks
Secondary	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

External Links

•   Public website to access telehealth system