e-CUIDACHEMO: Telerehabilitation During Chemotherapy in Breast Cancer (e-CUIDACHEMO)

July 21, 2017 updated by: Manuel Arroyo Morales, Universidad de Granada

e-CUIDACHEMO: Telerehabilitation During Chemotherapy in Breast Cancer Patients

Patients with breast cancer undergo a series of psiclofisicas alterations during cancer treatment, chemotherapy phase being one of the more aggressive ete effect. These changes reduce the quality of life and result in a loss of physical health-related condition. Studies have shown that the practice of physical exercise and rehabilitation strategies enhance or attenuate the impact of chemotherapy on quality of life of patients. At present, technological development from telerehabilitación systems is a promising strategy that enables fast and efficient communication between health professionals and patients, especially at this stage of the disease where the patient may encounter difficulties in matching measures improving their lifestyle with aggressive medical treatment.

To carry out this study a controlled study masked, parallel-group done were conducted usual care control group and an intervention based on a web system telerehabilitación to improve the physical condition associated with health and performed quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The CUIDATE group will identify impairments of participants at baseline assessment. The aims based on weekly improvements will be set to facilitate the final goal. After each training session there will be feedback between the participant and the CUIDATE group to change or improve any exercise or activity. This feedback will allow to us to select adequate exercises and levels of difficulty. As a result, a modifiable personal training will be assigned to each one focusing on cardio-respiratory, mobility, and endurance performance through online system rehabilitation (using written instructions, HD videos, and audio files).

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Granada, Spain, 18071
        • Faculty of Health Sciences. University of Granada

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Diagnosis of stage I, II, or IIIA breast cancer
  • Medical clearance of participation
  • Access to the Internet
  • Basic ability to use a computer or living with someone who has this ability
  • In chemotherapy treatment at present moment;
  • Have interest in improving lifestyle: fitness level
  • Have signed informed consent

Exclusion Criteria:

  • Chronic disease or orthopedic issues that would interfere with ability to participate in a physical activity program;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telerehabilitation
Resistence and endurance exercise adapted to individual requeriment using internet to monitor progression during chemotherapy treatment. Telerehabilitation eCUIDATE system
Device: Telerehabilitation eCUIDATE system
Resistence and endurance exercise adapted to individual requeriment during chemotherapy
No Intervention: Control group
usual care offered to patients during chemotherapy treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiorespiratory capacity
Time Frame: 1 day
Distance in meters in 6 minutes walking test
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abdominal endurance strength
Time Frame: 1 day
Abdominal resistance using curl-up test
1 day
Lumbar extensor endurance strength
Time Frame: 1 day
Lumbar extensor strength using dynamometer
1 day
Handgrip endurance strength
Time Frame: 1 day
Handgrip endurance using isometric dynamometer
1 day
Cancer related fatigue
Time Frame: 2 days
Piper Fatigue Scale
2 days
Cancer related pain
Time Frame: 2 days
Brief Pain Inventory
2 days
Cancer related quality of life
Time Frame: 2 days
EORTC Quality of life questionaire Core and Br23
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Granada

Collaborators

Health Service of Andalucia

Investigators

  • Principal Investigator: Manuel Arroyo-Morales, PhD, Universidad de Granada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

January 26, 2015

First Submitted That Met QC Criteria

January 28, 2015

First Posted (Estimate)

January 29, 2015

Study Record Updates

Last Update Posted (Actual)

July 25, 2017

Last Update Submitted That Met QC Criteria

July 21, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAS-0457-2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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