Telehealth System to Improve Quality of Life in Breast Cancer Survivors

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Universidad de Granada
Sponsor:
Collaborator:
Carlos III Health Institute
Information provided by (Responsible Party):
Manuel Arroyo Morales, Universidad de Granada
ClinicalTrials.gov Identifier:
NCT01801527
First received: February 27, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Behavioral: Telerehabilitation group
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: E-Cuidate: Effectiveness of a Telerehabilitation System in Women Breast Cancer Survivors

Resource links provided by NLM:


Further study details as provided by Universidad de Granada:

Primary Outcome Measures:
  • Quality of life [ Time Frame: Participants will be followed over 8 weeks ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Algometry [ Time Frame: Participants will be followed over 8 weeks ] [ Designated as safety issue: No ]
    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

  • The Visual Analogue Scale (VAS) for pain [ Time Frame: Participants will be followed over 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Participants will be followed over 8 weeks ] [ Designated as safety issue: Yes ]
    The Brief Pain Inventory (BPI) short form will be used to assess pain severity and pain interference

  • Body composition [ Time Frame: Participants will be followed over 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Participants will be followed over 8 weeks ] [ Designated as safety issue: No ]
    • 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

  • Cardiorespiratory fitness [ Time Frame: Participants will be followed over 8 weeks ] [ Designated as safety issue: No ]
    • 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

  • Fatigue [ Time Frame: Participants will be followed over 8 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Participants will be followed over 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Participants will be followed over 8 weeks ] [ Designated as safety issue: No ]
    • 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 [ Time Frame: Participants will be followed over 8 weeks ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 72
Study Start Date: March 2012
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telerehabilitation group Behavioral: Telerehabilitation group
Interventions will be based on to provide cardiovascular, mobility, strength and stretching exercises through telerehabilitation system
No Intervention: Control group
Information about usual care

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01801527

Contacts
Contact: Manuel Arroyo-Morales, PhD 958 248 030 marroyo@ugr.es

Locations
Spain
Faculty of Health Sciences. University of Granada Recruiting
Granada, Spain, 18071
Contact    958 020 245      
Principal Investigator: Manuel Arroyo-Morales, PhD         
Sub-Investigator: Noelia Galiano-Castillo, FPU AP2010-6075         
Sub-Investigator: Irene Cantarero-Villanueva, PhD         
Sub-Investigator: Carolina Fernández-Lao, PhD         
Sponsors and Collaborators
Universidad de Granada
Carlos III Health Institute
Investigators
Principal Investigator: Manuel Arroyo-Morales, PhD Faculty of Health Sciences. University of Granada
  More Information

Additional Information:
No publications provided by Universidad de Granada

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Manuel Arroyo Morales, PhD, Universidad de Granada
ClinicalTrials.gov Identifier: NCT01801527     History of Changes
Other Study ID Numbers: PI10/02749-02764
Study First Received: February 27, 2013
Last Updated: February 27, 2013
Health Authority: Spain: Carlos III Health Institute

Keywords provided by Universidad de Granada:
Telehealth
Fatigue
Breast cancer
Exercise
Quality of life
Telerehabilitation

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 01, 2014