NCT02350582

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 29, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

July 25, 2017

Status Verified

July 1, 2017

Enrollment Period

3.2 years

First QC Date

January 26, 2015

Last Update Submit

July 21, 2017

Conditions

Breast Cancer

Keywords

breast cancertelerehabilitationstrengthfatiguequality of life

Outcome Measures

Primary Outcomes (1)

  • Cardiorespiratory capacity

    Distance in meters in 6 minutes walking test

    1 day

Secondary Outcomes (6)

  • Abdominal endurance strength

    1 day

  • Lumbar extensor endurance strength

    1 day

  • Handgrip endurance strength

    1 day

  • Cancer related fatigue

    2 days

  • Cancer related pain

    2 days

  • +1 more secondary outcomes

Study Arms (2)

Telerehabilitation

EXPERIMENTAL

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

Device: Telerehabilitation eCUIDATE system

Control group

NO INTERVENTION

usual care offered to patients during chemotherapy treatment

Interventions

Telerehabilitation eCUIDATE systemDEVICE

Resistence and endurance exercise adapted to individual requeriment during chemotherapy

Telerehabilitation

Eligibility Criteria

Age25 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health Sciences. University of Granada

Granada, 18071, Spain

Location

Related Publications (1)

  • 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.

    PMID: 31342907DERIVED

MeSH Terms

Conditions

Breast NeoplasmsFatigue

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Manuel Arroyo-Morales, PhD

    Universidad de Granada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Profesor

Study Record Dates

First Submitted

January 26, 2015

First Posted

January 29, 2015

Study Start

April 1, 2012

Primary Completion

June 1, 2015

Study Completion

August 1, 2016

Last Updated

July 25, 2017

Record last verified: 2017-07

Locations

ES(1)