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. 2018 Jan 29;2018(1):CD011292. doi: 10.1002/14651858.CD011292.pub2

Galiano‐Castillo 2013.

Trial name or title Telehealth System to Improve Quality of Life in Breast Cancer Survivors
Methods Accrual: 72
 Accrual target: 80 breast cancer survivors
Multi‐centre/single‐centre: not reported but most likely home‐based (paper or registry does not explicitly say this)
Phase of trial: not reported
Country where trial is being conducted: Spain
 Any intended follow‐up details: 8 weeks
Stated study design: RCT, efficacy study
Participants Inclusion criteria:
• 18 to 65 years of age
• Female
• Diagnosis of stage I, II, or IIIA breast cancer
• Medical clearance for participation
• Without chronic disease or orthopaedic disease that would interfere with ability to participate in a physical activity programme
• 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
• Interest in improving lifestyle: fitness/stress level
• Signed informed consent
Exclusion criteria:
• Not reported
Interventions ARM 1:
  • Intervention details:

    • Behavioral telerehabilitation group: Interventions will be based on providing cardiovascular, mobility, strength, and stretching exercises through telerehabilitation system.


ARM 2:
  • Comparator details: information about usual care

Outcomes Primary outcome:
  • Quality of life (European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire 30)


Secondary outcomes:
  • Algometry (pressure pain thresholds measured through an electronic algometer)

  • Pain (visual analogue scale and brief pain inventory)

  • Body composition (weight, body mass index, skeletal muscle mass, and percentage of body fat obtained through bioelectrical impedance analysis)

  • Physical measurements (abdominal McQuade test, handgrip strength and back muscle strength via digital dynamometers, and multiple sit‐to‐stand test used to assess general lower extremity endurance)

  • Cardiorespiratory fitness (International Fitness Scale and 6‐minute walk test)

  • Fatigue via PFS‐Revised

  • Anxiety and depression via HADS

  • Cognitive function (Trail Making Test and Auditory Consonant Trigram)

  • Accelerometry (Actigraph tri‐axial accelerometer)

Starting date Start date: March 2012
Estimated completion date: July 2014
Contact information Manuel Arroyo‐Morales
Email: marroyo@ugr.es
Notes Trial registration link: https://clinicaltrials.gov/ct2/show/NCT01801527
Sponsor of the trial: Universidad de Granada and Carlos III Health Institute
 Intention‐to‐treat analysis: not reported
 Funding considerations: not funded by Pharma or otherwise