Effect of Telemonitoring on Functionality, Quality of Life and Risk of Lymphedema in Breast Cancer Survivors

NCT04779450 | Unknown

• 1 other identifier: Telemonitoring BCS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to evaluate the effectiveness of telemonitoring in the dysfunctions of the upper limbs in activities of daily living, quality of life and prevention of lymphedema in women undergoing treatment for breast cancer. Secondarily, to analyze the degree of satisfaction in the proposed treatment modality. This is a randomized controlled trial, double blind (evaluator and patient), parallel in three groups (synchronous telemonitoring group, asynchronous telemonitoring group and control group). The protocol will last six weeks, and quality of life, upper limb functionality, and risk of lymphedema will be evaluated. Both intervention groups will be submitted to a kinesiotherapy program three times a week, with synchronous and asynchronous monitoring, while the control group will receive usual post cancer orientations. Kinesiotherapy protocol in synchronous form compared to the usual recommendations in remote form is expected to show superior result in upper limb function and quality of life of women after breast cancer.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Upper Limb Functionality

  Quick Disabilities of the Arm, Shoulder and Hand (DASH) is an 11-item questionnaire designed to assess the physical disability and symptoms of the upper limbs during activities of daily living, during the week prior to the assessment. The questions are scored from 1 to 5, where 1 corresponds to "no difficulty" and 5 "could not do", and the higher the score, the higher the level of disability. The total score is 100 points, is calculated by adding the first total of answers, then dividing that number by the total number of items answered, this value is subtracted by 1 and multiplied by 25.

  Change in Quick DASH total score Pre-intervention at 6 weeks Post-intervention

• Assessment of quality of life

  European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire BR-23 was developed in 1996 by the European Organization for Research and Treatment of Cancer (EORTC) specifically to assess quality of life in patients with breast cancer. The EORTC QLQ-BR-23 comprises 23 questions and assesses the symptoms experienced in the last week, and has two domains (functional and symptoms). The answers are displayed on a Likert scale, with values from 1 to 4, in which case the higher the final score, the better the quality of life.

  Change in EORTC QLQ BR-23 total score Pre-intervention at 6 weeks Post-intervention

Secondary Outcomes (2)

• Arm circumference

  Change from Pre Intervention Circumference of the arm at 6 weeks Post Intervention

• Level of satisfaction

  6 weeks Post Intervention

Study Arms (3)

Synchronous Telemonitoring

EXPERIMENTAL

The sessions will be supervised by a therapist and conducted via video call using the WhatsApp® application, lasting 50 minutes, 3 times a week, for 6 consecutive weeks, the exercises will basically consist of active stretching, mobilization and scapular stabilization, and active shoulder exercises with gradual range of motion.

Other: Kinesiotherapy protocol

Asynchronous Telemonitoring

EXPERIMENTAL

An explicative schedule with the exercises to be performed asynchronously during the week will be delivered weekly via e-mail and WhatsApp®. The exercises will be the same as those performed by the synchronous telemonitoring group, and the participant will be free to ask any questions about the protocol to the therapist at any time via text message or e-mail.

Other: Kinesiotherapy protocol

Control Group

ACTIVE COMPARATOR

Will receive only a booklet of usual guidelines for women after breast cancer, such as skin care, return to activities, upper limb functionality, self-care, lymphedema and physical activity practice.

Other: Usual orientations

Interventions

Kinesiotherapy protocol OTHER

The kinesiotherapy protocol is an exercise-based treatment designed to gain upper limb range of motion and muscle strengthening.

Asynchronous Telemonitoring; Synchronous Telemonitoring

Usual orientations OTHER

Usual orientations for post-breast cancer women, such as skin care, return to activities, upper limb functionality, self-care, lymphedema, and physical activity practice.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18;
• Diagnosed with breast cancer and submitted to surgical treatment, regardless of the type of surgery;
• With up to 24 months post-operatively, already completed cycles of adjuvant therapies (radiotherapy and/or chemotherapy);
• Moderate functional disability with a minimum score of 30% QuickDash questionnaire;
• Impaired quality of life;
• Able to understand and access mobile applications or live with someone who assists, has internet access and telephone contact.

You may not qualify if:

• open lesions;
• acquired infections;
• chronic disease or previous motor sequelae that would interfere with participation in the study;
• women who have difficulty understanding the questions or questionnaires applied or proposed activities;
• diagnosis of lymphedema;
• have no functional alterations in the upper limbs or quality of life.

Sponsors & Collaborators

• University of the State of Santa Catarina: lead

Study Sites (1)

Santa Catarina State University

Florianópolis, Santa Catarina, 88080350, Brazil

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Gilmar M Santos, PhD

  university of santa catarina state

  STUDY CHAIR

Central Study Contacts

Maria Luiza Pereira, PT

CONTACT

+55 (48) 99818-3165; mluiza.pereira@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Teacher

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 3, 2021
• Study Start: August 1, 2021
• Primary Completion: August 1, 2021
• Study Completion: December 1, 2021
• Last Updated: May 13, 2021

Record last verified: 2021-05

Locations

BR (1)