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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Telerehabilitation eCUIDATE system
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring breast cancer, telerehabilitation, strength, fatigue, quality of life

Eligibility Criteria

25 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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;

Sites / Locations

  • Faculty of Health Sciences. University of Granada

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Telerehabilitation

Control group

Arm Description

Resistence and endurance exercise adapted to individual requeriment using internet to monitor progression during chemotherapy treatment. Telerehabilitation eCUIDATE system

usual care offered to patients during chemotherapy treatment

Outcomes

Primary Outcome Measures

Cardiorespiratory capacity
Distance in meters in 6 minutes walking test

Secondary Outcome Measures

Abdominal endurance strength
Abdominal resistance using curl-up test
Lumbar extensor endurance strength
Lumbar extensor strength using dynamometer
Handgrip endurance strength
Handgrip endurance using isometric dynamometer
Cancer related fatigue
Piper Fatigue Scale
Cancer related pain
Brief Pain Inventory
Cancer related quality of life
EORTC Quality of life questionaire Core and Br23

Full Information

First Posted
January 26, 2015
Last Updated
July 21, 2017
Sponsor
Universidad de Granada
Collaborators
Health Service of Andalucia
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1. Study Identification

Unique Protocol Identification Number
NCT02350582
Brief Title
e-CUIDACHEMO: Telerehabilitation During Chemotherapy in Breast Cancer
Acronym
e-CUIDACHEMO
Official Title
e-CUIDACHEMO: Telerehabilitation During Chemotherapy in Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada
Collaborators
Health Service of Andalucia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, telerehabilitation, strength, fatigue, quality of life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telerehabilitation
Arm Type
Experimental
Arm Description
Resistence and endurance exercise adapted to individual requeriment using internet to monitor progression during chemotherapy treatment. Telerehabilitation eCUIDATE system
Arm Title
Control group
Arm Type
No Intervention
Arm Description
usual care offered to patients during chemotherapy treatment
Intervention Type
Device
Intervention Name(s)
Telerehabilitation eCUIDATE system
Intervention Description
Resistence and endurance exercise adapted to individual requeriment during chemotherapy
Primary Outcome Measure Information:
Title
Cardiorespiratory capacity
Description
Distance in meters in 6 minutes walking test
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Abdominal endurance strength
Description
Abdominal resistance using curl-up test
Time Frame
1 day
Title
Lumbar extensor endurance strength
Description
Lumbar extensor strength using dynamometer
Time Frame
1 day
Title
Handgrip endurance strength
Description
Handgrip endurance using isometric dynamometer
Time Frame
1 day
Title
Cancer related fatigue
Description
Piper Fatigue Scale
Time Frame
2 days
Title
Cancer related pain
Description
Brief Pain Inventory
Time Frame
2 days
Title
Cancer related quality of life
Description
EORTC Quality of life questionaire Core and Br23
Time Frame
2 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuel Arroyo-Morales, PhD
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Health Sciences. University of Granada
City
Granada
ZIP/Postal Code
18071
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
31342907
Citation
Ariza-Garcia A, Lozano-Lozano M, Galiano-Castillo N, Postigo-Martin P, Arroyo-Morales M, Cantarero-Villanueva I. A Web-Based Exercise System (e-CuidateChemo) to Counter the Side Effects of Chemotherapy in Patients With Breast Cancer: Randomized Controlled Trial. J Med Internet Res. 2019 Jul 24;21(7):e14418. doi: 10.2196/14418.
Results Reference
derived
Links:
URL
http://www.cuidateconnosotros.com
Description
public free web section of telerehabilitation system

Learn more about this trial

e-CUIDACHEMO: Telerehabilitation During Chemotherapy in Breast Cancer

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