Wearable Enhanced Fitness Tracking for Metastatic Breast Cancer Patients Using Endocrine Treatment and Palbociclib
NCT ID: NCT05277935
Last Updated: 2024-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
68 participants
INTERVENTIONAL
2022-04-22
2025-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Use of the WeCancer app combined with the smartwatch
The Wecancer app will be used in a way, combined with a smartwatch, similar to those used in professional fitness programs, with active measures, which may include, for example: notifications with personalized advice (via chat), feedback to the patient in the comments made, guidance on physical and eating exercises, reception and support from the Wecancer multidisciplinary team, consisting of a navigator nurse, psychologist, nutritionist and physiotherapist. During the survey period, participants should report their symptoms on the Wecancer app whenever possible, preferably daily.
Use of the WeCancer app combined with the smartwatch.
To evaluate if a fitness tracker added to eHealth technology will improve quality of life compared to the use of eHealth technology alone in metastasis breast cancer patients treated with palbociclib and endocrine therapy
Using the WeCancer app
The Wecancer application similar to those used in professional fitness programs, with active measures, which may include, for example: notifications with personalized advice (via chat), patient feedback on the comments made, guidance on physical and dietary exercises, reception and support of the Multidisciplinary cancer team composed of a navigator nurse, a psychologist, nutritionist and physiotherapist. During the research period, participants must report your symptoms in the Wecancer app whenever possible, preferably daily.
No interventions assigned to this group
Interventions
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Use of the WeCancer app combined with the smartwatch.
To evaluate if a fitness tracker added to eHealth technology will improve quality of life compared to the use of eHealth technology alone in metastasis breast cancer patients treated with palbociclib and endocrine therapy
Eligibility Criteria
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Inclusion Criteria
* The patient must be on treatment for at least three (3) months with Palbociclib and endocrine therapy.
* Evidence of a signed and dated informed consent document, physically or digitally, indicating that the research participant was informed about all relevant aspects of the study;
* The patient agrees not to participate in another study with drug intervention while on treatment.
* Have performance status according to the Eastern Cooperative Oncology Group
* Have access to a compatible smartphone and 3G or 4G internet connection
Exclusion Criteria
* Patients who have a life expectancy of \< 3 months.
* Treatment with any product under investigation during the last 28 days;
* Another acute or chronic medical or psychiatric condition or severe laboratory abnormality that could increase the risk associated with participation in the study or that Page 10 de 21 Version 6.0 could interfere with the interpretation of the study results and, in the investigator's judgment, would make the research participant unsuitable for inclusion in the study. study.
* Illiterate patients or those with a low level of education that may prevent the correct use of the Wecancer application and/or the watch with monitoring of physical activity.
18 Years
FEMALE
No
Sponsors
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Beneficência Portuguesa de São Paulo
OTHER
Responsible Party
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Graziela Zibetti Dal Molin
MD
Principal Investigators
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Graziela Dal Molin, MD
Role: PRINCIPAL_INVESTIGATOR
Beneficência Portuguesa de São Paulo
Locations
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Oncoclínicas
Rio de Janeiro, , Brazil
A Beneficência Portuguesa de São Paulo
São Paulo, , Brazil
A.C.Camargo Cancer Center
São Paulo, , Brazil
Centro Paulista de Oncologia
São Paulo, , Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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WEFITTER
Identifier Type: -
Identifier Source: org_study_id
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