Tele-rehabilitation in Women With Breast Cancer During COVID-19 Pandemic.

NCT05530876 | Unknown

• 1 other identifier: 33293720.9.0000.5505
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Cancer is the main public health problem in the world and is already among the main causes of death. Breast CA will be the second most common type of cancer in the Brazilian population between 2020-2022. The pandemic caused by COVID-19 brought several changes in society, affecting health services, one of which was the need to maintain regular treatment for various health conditions, such as cancer. Physical therapy is an essential part of the multidisciplinary treatment of cancer patients. With the new technologies available, it is possible to allow continuous treatment of cancer patients, even during quarantine, and one possibility is the application of information and communication technologies to provide rehabilitation therapy to remote people, called home telerehabilitation. Objective: To verify the effect of virtual reality (VR) training on motor performance, pain and heart rate variability variables in patients diagnosed with breast cancer. Methods: The study will be composed of 30 women over 18 years old with a diagnosis of breast cancer attended at an oncology physical therapy clinic in the city of Juiz de Fora - MG. Participants will undergo training using virtual reality technology, always guided by the researcher. There will be a total of 10 (ten) interventions, with two training sessions per week. The participant will be guided by a researcher who will instruct her online. Five games will be used: Reaction Time, Coincident Timing, Fitts, Genius, MoveHero. Participants will answer some questionnaires and scales such as EORTC QLQ-C30 which assesses quality of life in cancer patients, perceived exertion scale will be applied before and between matches, a mood scale (BRUMS) will be applied at the beginning and at the end of training and Affective Analog Face Scale for pain assessment and analysis of Heart Rate Variability (HRV) that will be performed before, during and after the first and last training, through a heart rate monitor that will be given to each participant and an application cell phone (Elite HRV).

Conditions

Breast Cancer

Keywords

Breast Cancer; Virtual Reality Exposure Therapy; Telerehabilitation; Remote Rehabilitation; Virtual Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Improvements in heart rate variability indices and rate of perceived exertion after intervention with telerehabilitation.

  Heart rate variability indices measures through a cardiofrequencymeter and rate of perceived exertion through Borg scale before and after 10 session of telerehabilitation.

  5 weeks

Secondary Outcomes (1)

• Improvements in quality of life after intervention with telerehabilitation.

  5 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

Women with breast cancer who will undergo the intervention with virtual game.

Other: Telerehabilitation with virtual game

Control Group

ACTIVE COMPARATOR

Healthy women who will undergo the intervention with virtual game.

Other: Telerehabilitation with virtual game

Interventions

Telerehabilitation with virtual game OTHER

It will be applied 10 sessions of remote rehabilitation in women with and without breast cancer, in order to promote physical activity.

Control Group; Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients over 18 years old with a diagnosis of breast AC, who agree to participate in the research and present an understanding compatible with the execution of the procedures, will be invited to participate in the study.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Comitê de Ética da Universidade Federal

São Paulo, 04.023-900, Brazil

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Talita D Silva, Ph.D.

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 7, 2022
• Study Start: March 2, 2020
• Primary Completion: December 2, 2021
• Study Completion: December 2, 2022
• Last Updated: September 7, 2022

Record last verified: 2022-09

Locations

BR (1)