e-CUIDACHEMO: Telerehabilitation During Chemotherapy in Breast Cancer

NCT ID: NCT02350582

Last Updated: 2017-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2016-08-31

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).

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Telerehabilitation

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

Group Type: EXPERIMENTAL

Telerehabilitation eCUIDATE system

Intervention Type: DEVICE

Resistence and endurance exercise adapted to individual requeriment during chemotherapy

Control group

usual care offered to patients during chemotherapy treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Telerehabilitation eCUIDATE system

Resistence and endurance exercise adapted to individual requeriment during chemotherapy

Intervention Type: DEVICE

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;

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Health Service of Andalucia

OTHER_GOV

Sponsor Role: collaborator

Universidad de Granada

OTHER

Sponsor Role: lead

Responsible Party

Manuel Arroyo Morales

Associate Profesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manuel Arroyo-Morales, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Granada

Locations

Faculty of Health Sciences. University of Granada

Granada, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 31342907 (View on PubMed)

Other Identifiers

SAS-0457-2010

Identifier Type: -

Identifier Source: org_study_id