Wearable Enhanced Fitness Tracking for Metastatic Breast Cancer Patients Using Endocrine Treatment and Palbociclib
- Conditions
- Breast Neoplasm FemaleQuality of Life
- Registration Number
- NCT05277935
- Lead Sponsor
- Beneficência Portuguesa de São Paulo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Female patients = 18 years of age diagnosed with hormone receptor-positive/ human<br> epidermal growth factor receptor 2- negative metastatic breast cancer undergoing<br> treatment with Palbociclib combined with aromatase inhibitors (letrozole, exemestane<br> or anastrozole) or fulvestrant as first-line therapy, or in treatment with<br> Palbociclib and fulvestrant as second-line or posterior-line therapy in the<br> metastatic setting; may be using ovarian suppression if the patient is<br> premenopausal.<br><br> - The patient must be on treatment for at least three (3) months with Palbociclib and<br> endocrine therapy.<br><br> - Evidence of a signed and dated informed consent document, physically or digitally,<br> indicating that the research participant was informed about all relevant aspects of<br> the study;<br><br> - The patient agrees not to participate in another study with drug intervention while<br> on treatment.<br><br> - Have performance status according to the Eastern Cooperative Oncology Group<br><br> - Have access to a compatible smartphone and 3G or 4G internet connection<br><br>Exclusion Criteria:<br><br> - Patients considered to be at poor medical risk due to uncontrolled serious medical<br> disorder, non-malignant systemic disease, or active uncontrolled infection.<br> Examples: uncontrolled ventricular arrhythmia, recent myocardial infarction (within<br> 6 months), stroke, gastrointestinal bleeding, or any psychiatric disorder that<br> precludes informed consent; between others.<br><br> - Patients who have a life expectancy of < 3 months.<br><br> - Treatment with any product under investigation during the last 28 days;<br><br> - Another acute or chronic medical or psychiatric condition or severe laboratory<br> abnormality that could increase the risk associated with participation in the study<br> or that Page 10 de 21 Version 6.0 could interfere with the interpretation of the<br> study results and, in the investigator's judgment, would make the research<br> participant unsuitable for inclusion in the study. study.<br><br> - Illiterate patients or those with a low level of education that may prevent the<br> correct use of the Wecancer application and/or the watch with monitoring of physical<br> activity.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assess quality of life through the quality-of-life questionnaire through the Functional Assessment of Cancer Therapy - Breast;Assess quality of life through the quality-of-life questionnaire through the Functional Assessment of Cancer Therapy - Breast;Assess quality of life through the quality-of-life questionnaire through the Functional Assessment of Cancer Therapy - Breast;Assess quality of life through the quality-of-life questionnaire through the Functional Assessment of Cancer Therapy - Breast
- Secondary Outcome Measures
Name Time Method