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

Breast Cancer Clinical Trial

Official title:

The Effect of Telemonitoring on Upper Limb Function, Quality of Life and Risk of Lymphedema During and After Pandemic COVID-19 in Women Submitted to Treatment for Breast Cancer: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04779450
• Other study ID #: Telemonitoring BCS
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: December 2021

Study information

• Verified date: May 2021
• Source: University of the State of Santa Catarina
• Contact: Maria Luiza Pereira, PT
• Phone: +55 (48) 99818-3165
• Email: mluiza.pereira[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a randomized, double blind (evaluator and patient), parallel control trial in three groups (synchronous telemonitoring group, asynchronous telemonitoring group, and control group). The allocation of the participants will be done by an external member, through a masked draw, the name of each participant will be in numbered opaque envelopes, which will only be opened after the initial evaluation, to blind the evaluating therapist, a second therapist will be responsible for the application of the interventions. The protocol for the intervention groups will last 6 weeks, and the exercises will basically consist of active stretching, mobilization and scapular stabilization, and active shoulder exercises with gradual range of motion. The intervention was based on previous studies that used standard kinesiotherapy in their outcomes.

The sessions for the synchronous telemonitoring group will be supervised and conducted via video call using the WhatsApp® application, lasting 50 minutes, 3 times a week.

For the asynchronous telemonitoring group, an explanatory schedule with the exercises to be performed during the week will be delivered weekly via e-mail and WhatsApp®. The exercises will be the same as those performed by the previous group, and the participant will be free to ask any questions about the protocol with the therapist at any time via text message or e-mail. The control group will receive only the usual orientation booklet for post-breast cancer women. The participants who agree to participate in the research will sign the Informed Consent Form, and may withdraw from the research at any stage of the study. Assessment and intervention collection will take place via video call. The personal identification data of the participants will be preserved in accordance with the resolution of the national health council, taking into account the possibility of scientific dissemination of the results obtained. The selection method adopted will be non-probability sampling, convenience sampling. The participants of the study will be recruited in the reference hospital for oncologic care in Florianópolis- State of Santa Catarina/Brazil, the Oncology Research Center, through a retrospective and active search in the medical records, in order to recover clinical data and contact of the participants with up to 24 months after the curative surgical intervention. There will also be recruitment through dissemination of the study via media and social networks, folders and messages, so that women voluntarily apply for the research. The sample will consist of women diagnosed with breast cancer and undergoing surgical treatment, with up to 24 months postoperatively, present functional disability and impaired quality of life, able to understand and access mobile applications or live with someone who helps them, have access to the internet and telephone for contact.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Lymphedema

Intervention

Other:
• Kinesiotherapy protocol
The kinesiotherapy protocol is an exercise-based treatment designed to gain upper limb range of motion and muscle strengthening.
• Usual orientations
Usual orientations for post-breast cancer women, such as skin care, return to activities, upper limb functionality, self-care, lymphedema, and physical activity practice.

Locations

Country	Name	City	State
Brazil	Santa Catarina State University	Florianópolis	Santa Catarina

Sponsors (1)

Lead Sponsor	Collaborator
University of the State of Santa Catarina

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Arm circumference	The circumference of the arm will be evaluated by the perimeter.	Change from Pre Intervention Circumference of the arm at 6 weeks Post Intervention
Secondary	Level of satisfaction	Evaluated qualitatively and quantitatively, addressed only at the re-evaluation period questions such as, " How was your experience with this treatment modality?", "From zero to ten, how much would you recommend this treatment modality?", "From zero to ten, how satisfied were you with this intervention?"	6 weeks Post Intervention