Using fitness tracking technology to improve quality of life for metastatic breast cancer patients on treatment
Wearable Enhanced Fitness Tracking for Metastatic Breast Cancer Patients Using Endocrine Treatment and Palbociclib
This study is testing if using a fitness app and smartwatch can help improve the quality of life for women with hormone receptor-positive metastatic breast cancer who are receiving treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Beneficência Portuguesa de São Paulo Academic / other |
| Locations | 4 sites (Rio de Janeiro and 3 other locations) |
| Trial ID | NCT05277935 on ClinicalTrials.gov |
What this trial studies
This study evaluates the quality of life in female patients with hormone receptor-positive metastatic breast cancer who are being treated with Palbociclib and endocrine therapy. It combines the use of a digital health app, WeCancer, with a smartwatch to monitor physical activity and gather real-time patient-reported outcomes. Participants will be assessed using validated quality of life measures, including the Functional Assessment of Cancer Therapy - Breast and EuroQol -5D. The goal is to determine if this integrated approach can enhance patient well-being during treatment.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 18 and older with hormone receptor-positive metastatic breast cancer currently receiving Palbociclib and endocrine therapy.
Not a fit: Patients who are not undergoing treatment with Palbociclib or those with different types of breast cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for patients undergoing treatment for metastatic breast cancer.
How similar studies have performed: While the integration of fitness tracking with cancer treatment is a novel approach, similar studies have shown promise in enhancing patient engagement and outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female patients ≥ 18 years of age diagnosed with hormone receptor-positive/ human epidermal growth factor receptor 2- negative metastatic breast cancer undergoing treatment with Palbociclib combined with aromatase inhibitors (letrozole, exemestane or anastrozole) or fulvestrant as first-line therapy, or in treatment with Palbociclib and fulvestrant as second-line or posterior-line therapy in the metastatic setting; may be using ovarian suppression if the patient is premenopausal. * 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 considered to be at poor medical risk due to uncontrolled serious medical disorder, non-malignant systemic disease, or active uncontrolled infection. Examples: uncontrolled ventricular arrhythmia, recent myocardial infarction (within 6 months), stroke, gastrointestinal bleeding, or any psychiatric disorder that precludes informed consent; between others. * 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.
Where this trial is running
Rio de Janeiro and 3 other locations
- Oncoclínicas — Rio de Janeiro, Brazil (Recruiting)
- A Beneficência Portuguesa de São Paulo — São Paulo, Brazil (Recruiting)
- A.C.Camargo Cancer Center — São Paulo, Brazil (Recruiting)
- Centro Paulista de Oncologia — São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Graziela Dal Molin, MD — Beneficência Portuguesa de São Paulo
- Study coordinator: Bianca Verboski
- Email: naipe@bp.org.br
- Phone: 11-35052639
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.