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

ClinicalTrials.gov ID

NCT05277935

Lead Sponsor

Beneficência Portuguesa de São PauloOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

68Estimated

Last Update Posted

Aug 26, 2024Actual

Start Date

Apr 22, 2022Actual

Primary Completion Date

Mar 1, 2025Estimated

Completion Date

Mar 1, 2025Estimated

Official Title

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

Brief 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.

Detailed Description

Measure the quality of life of patients with metastatic breast cancer treated with Palbociclib and endocrine therapy using the Functional Assessment of Cancer Therapy - Breast and EuroQol -5D - European quality of life in five dimensions and compare the group using the Wecancer digital health app with the group using Wecancer and the physical activity monitoring smartwatch.

• Breast Neoplasm Female
• Quality of Life

• Use of the WeCancer app combined with the smartwatch.

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

No

Eligibility 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.

Primary Purpose

Other

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Beneficência Portuguesa de São PauloOTHER

bianca.verboski@bp.org.br+551135055031

marcelle.goldner@gmail.com+55 11 93148-9664

mayara.pinto@oncoclinicas.com+55 11 2678-5800 ext. 5433

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