Breast CancerNCT04779450
Effect of Telemonitoring on Functionality, Quality of Life and Risk of Lymphedema in Breast Cancer Survivors
A study testing Kinesiotherapy protocol and Usual orientations in people with Breast Cancer, run by University of the State of Santa Catarina at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Kinesiotherapy protocol and Usual orientations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2021to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Santa Catarina State University
Florianópolis, Santa Catarina, 88080350
Gilmar M Santos, PhD, +55 (48) 99909-9459, gilmar.santos@udesc.br
Gilmar M Santos, PhD
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Kinesiotherapy protocol, Usual orientations
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesiotherapy protocolOther
The kinesiotherapy protocol is an exercise-based treatment designed to gain upper limb range of motion and muscle strengthening.
Usual orientationsOther
Usual orientations for post-breast cancer women, such as skin care, return to activities, upper limb functionality, self-care, lymphedema, and physical activity practice.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Usual orientations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change in EORTC QLQ BR-23 total score Pre-intervention at 6 weeks Post-intervention
Secondary outcomes (2)
Arm circumference
The circumference of the arm will be evaluated by the perimeter.
Measured: Change from Pre Intervention Circumference of the arm at 6 weeks Post Intervention
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?"
Measured: 6 weeks Post Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start1 Aug 2021 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the State of Santa Catarina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gilmar Moraes Santos, PT, University of the State of Santa Catarina
- Investigators
- Gilmar M Santos, PhD, Study chair, university of santa catarina state
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779450
- Sponsor's protocol ID
- Telemonitoring BCS
- Status last verified
- May 2021
- First submitted
- 1 Mar 2021
- Last updated
- 13 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04779450
- Acronym / sponsor ID
- Telemonitoring BCS
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of the State of Santa CatarinaUniversity, hospital or other
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Synchronous Telemonitoring | Experimental | Other: Kinesiotherapy protocolThe 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. |
| Asynchronous Telemonitoring | Experimental | Other: Kinesiotherapy protocolAn 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. |
| Control Group | Active comparator | Other: Usual orientationsWill 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinesiotherapy protocolThe kinesiotherapy protocol is an exercise-based treatment designed to gain upper limb range of motion and muscle strengthening. | Other | Asynchronous Telemonitoring, Synchronous Telemonitoring |
| Usual orientationsUsual orientations for post-breast cancer women, such as skin care, return to activities, upper limb functionality, self-care, lymphedema, and physical activity practice. | Other | Control Group |
Primary outcome
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.
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.
2 secondary outcomes
Arm circumference
Time frame: Change from Pre Intervention Circumference of the arm at 6 weeks Post Intervention
Level of satisfaction
Time frame: 6 weeks Post Intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilmar M Santos, PhD study chair
university of santa catarina state
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiotherapy protocol and Usual orientations in people with Breast Cancer, run by University of the State of Santa Catarina at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Luiza Pereira, PT (+55 (48) 99818-3165, mluiza.pereira@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper Limb Functionality (time frame: Change in Quick DASH total score Pre-intervention at 6 weeks Post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2021.