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

Quality of Life Clinical Trial

— WEFITTER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05277935
• Other study ID #: WEFITTER
• Status: Recruiting
• Phase: N/A
• Start date: April 22, 2022
• Est. completion date: May 31, 2024

Study information

• Verified date: July 2023
• Source: Beneficência Portuguesa de São Paulo
• Contact: Bianca Verboski
• Phone: 11-35052639
• Email: naipe[@]bp.org.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: May 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasm Female
• Breast Neoplasms
• Quality of Life

Intervention

Device:
• 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

Locations

Country	Name	City	State
Brazil	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

Sponsors (1)

Lead Sponsor	Collaborator
Beneficência Portuguesa de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess quality of life through the quality-of-life questionnaire through the Functional Assessment of Cancer Therapy - Breast	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 compare the group using the Wecancer digital health app with the group using Wecancer and the physical activity monitoring smartwatch.; The comparison of the two groups in relation to quality of life, measured by the general score of the Functional Assessment of Cancer Therapy - Breast and its sub-items, over time will be made using a linear model withmixed effects, that is, fixed effects and random effects. Time and group fixed effects will be considered, the patient will be considered random effect. The effects of time, group and interaction between them will be tested.	Baseline
Primary	Assess quality of life through the quality-of-life questionnaire through the Functional Assessment of Cancer Therapy - Breast	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 compare the group using the Wecancer digital health app with the group using Wecancer and the physical activity monitoring smartwatch.; The comparison of the two groups in relation to quality of life, measured by the general score of the Functional Assessment of Cancer Therapy - Breast and its sub-items, over time will be made using a linear model withmixed effects, that is, fixed effects and random effects. Time and group fixed effects will be considered, the patient will be considered random effect. The effects of time, group and interaction between them will be tested.	Follow up 2 month
Primary	Assess quality of life through the quality-of-life questionnaire through the Functional Assessment of Cancer Therapy - Breast	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 compare the group using the Wecancer digital health app with the group using Wecancer and the physical activity monitoring smartwatch.; The comparison of the two groups in relation to quality of life, measured by the general score of the Functional Assessment of Cancer Therapy - Breast and its sub-items, over time will be made using a linear model withmixed effects, that is, fixed effects and random effects. Time and group fixed effects will be considered, the patient will be considered random effect. The effects of time, group and interaction between them will be tested.	Follow up 4 month
Primary	Assess quality of life through the quality-of-life questionnaire through the Functional Assessment of Cancer Therapy - Breast	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 compare the group using the Wecancer digital health app with the group using Wecancer and the physical activity monitoring smartwatch.; The comparison of the two groups in relation to quality of life, measured by the general score of the Functional Assessment of Cancer Therapy - Breast and its sub-items, over time will be made using a linear model withmixed effects, that is, fixed effects and random effects. Time and group fixed effects will be considered, the patient will be considered random effect. The effects of time, group and interaction between them will be tested.	Follow up 6 month