RecruitingNot ApplicableNCT05277935

Wearable Enhanced Fitness Tracking for Metastatic Breast Cancer Patients Using Endocrine Treatment and Palbociclib

Sponsor

Beneficência Portuguesa de São Paulo

Enrollment

68 participants

Start Date

Apr 22, 2022

Study Type

INTERVENTIONAL

Conditions

Quality of Life Breast Neoplasm Female

Summary

Combining a fitness tracker technology with real-time patient-reported outcome monitoring associated with interventions through a health care app is a novel strategy to evaluate metastatic breast cancer patients using Palbociclib and endocrine treatment.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria6

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 Criteria5

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.

Interventions

DEVICEUse 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