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Completed

NCT Number: NCT01801527

Telehealth System to Improve Quality of Life in 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.

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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Key information

Conditions

Breast Cancer Behavior Breast Diseases Breast Neoplasms Fatigue Motor Activity Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Health Sciences. University of Granada

Granada, 18071, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telerehabilitation group

Behavioral

Interventions will be based on to provide cardiovascular, mobility, strength and stretching exercises through telerehabilitation system

Primary outcomes

  1. 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

Secondary outcomes

  1. Algometry

    Time frame: 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

  2. The Visual Analogue Scale (VAS) for pain

    Time frame: 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

  3. Pain

    Time frame: Participants will be followed over 8 weeks

    The Brief Pain Inventory (BPI) short form will be used to assess pain severity and pain interference

  4. Body composition

    Time frame: 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)

  5. Physical measurement

    Time frame: 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

  6. Cardiorespiratory fitness

    Time frame: 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

  7. Fatigue

    Time frame: 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

  8. Anxiety and depression

    Time frame: 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

  9. Cognitive function

    Time frame: 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

  10. Accelerometry

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Collaborators

  • Carlos III Health Institute

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 28, 2013
Registry last updated
Oct 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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