- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04779450
Effect of Telemonitoring on Functionality, Quality of Life and Risk of Lymphedema in Breast Cancer Survivors
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Maria Luiza Pereira, PT
- Phone Number: +55 (48) 99818-3165
- Email: mluiza.pereira@outlook.com
Study Locations
-
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Santa Catarina
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Florianópolis, Santa Catarina, Brazil, 88080350
- Recruiting
- Santa Catarina State University
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Contact:
- Gilmar M Santos, PhD
- Phone Number: +55 (48) 99909-9459
- Email: gilmar.santos@udesc.br
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Principal Investigator:
- Gilmar M Santos, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Synchronous Telemonitoring
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.
|
The kinesiotherapy protocol is an exercise-based treatment designed to gain upper limb range of motion and muscle strengthening.
|
EXPERIMENTAL: Asynchronous Telemonitoring
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.
|
The kinesiotherapy protocol is an exercise-based treatment designed to gain upper limb range of motion and muscle strengthening.
|
ACTIVE_COMPARATOR: Control Group
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.
|
Usual orientations for post-breast cancer women, such as skin care, return to activities, upper limb functionality, self-care, lymphedema, and physical activity practice.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Upper Limb Functionality
Time Frame: Change in Quick DASH total score Pre-intervention at 6 weeks Post-intervention
|
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
Time Frame: Change in EORTC QLQ BR-23 total score Pre-intervention at 6 weeks Post-intervention
|
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.
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Change in EORTC QLQ BR-23 total score Pre-intervention at 6 weeks Post-intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Arm circumference
Time Frame: Change from Pre Intervention Circumference of the arm at 6 weeks Post Intervention
|
The circumference of the arm will be evaluated by the perimeter.
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Change from Pre Intervention Circumference of the arm at 6 weeks Post Intervention
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Level of satisfaction
Time Frame: 6 weeks Post Intervention
|
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
|
Collaborators and Investigators
Investigators
- Study Chair: Gilmar M Santos, PhD, university of santa catarina state
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Telemonitoring BCS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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