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


Phase 2
18 Years
65 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Outcome Measure:

Quality of life

Outcome Description:

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

Outcome Time Frame:

Participants will be followed over 8 weeks

Safety Issue:

Yes

Principal Investigator

Manuel Arroyo-Morales, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Faculty of Health Sciences. University of Granada

Authority:

Spain: Carlos III Health Institute

Study ID:

PI10/02749-02764

NCT ID:

NCT01801527

Start Date:

March 2012

Completion Date:

Related Keywords:

  • Breast Cancer
  • Telehealth
  • Fatigue
  • Breast cancer
  • Exercise
  • Quality of life
  • Telerehabilitation
  • Breast Neoplasms

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