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

Sponsor

Beneficência Portuguesa de São Paulo (Other)

Overall Status

Recruiting

CT.gov ID

NCT05277935

Collaborator

(none)

Enrollment

Locations

Arms

11.3

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasm Female Quality of Life	Device: Use of the WeCancer app combined with the smartwatch.	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Apr 22, 2022

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Use of the WeCancer app combined with the smartwatch The Wecancer app will be used in a way, combined with a smartwatch, similar to those used in professional fitness programs, with active measures, which may include, for example: notifications with personalized advice (via chat), feedback to the patient in the comments made, guidance on physical and eating exercises, reception and support from the Wecancer multidisciplinary team, consisting of a navigator nurse, psychologist, nutritionist and physiotherapist. During the survey period, participants should report their symptoms on the Wecancer app whenever possible, preferably daily.	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
No Intervention: Using the WeCancer app The Wecancer application similar to those used in professional fitness programs, with active measures, which may include, for example: notifications with personalized advice (via chat), patient feedback on the comments made, guidance on physical and dietary exercises, reception and support of the Multidisciplinary cancer team composed of a navigator nurse, a psychologist, nutritionist and physiotherapist. During the research period, participants must report your symptoms in the Wecancer app whenever possible, preferably daily.

Arm

Intervention/Treatment

Active Comparator: Use of the WeCancer app combined with the smartwatch

The Wecancer app will be used in a way, combined with a smartwatch, similar to those used in professional fitness programs, with active measures, which may include, for example: notifications with personalized advice (via chat), feedback to the patient in the comments made, guidance on physical and eating exercises, reception and support from the Wecancer multidisciplinary team, consisting of a navigator nurse, psychologist, nutritionist and physiotherapist. During the survey period, participants should report their symptoms on the Wecancer app whenever possible, preferably daily.

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

No Intervention: Using the WeCancer app

The Wecancer application similar to those used in professional fitness programs, with active measures, which may include, for example: notifications with personalized advice (via chat), patient feedback on the comments made, guidance on physical and dietary exercises, reception and support of the Multidisciplinary cancer team composed of a navigator nurse, a psychologist, nutritionist and physiotherapist. During the research period, participants must report your symptoms in the Wecancer app whenever possible, preferably daily.

Outcome Measures

Primary Outcome Measures

Assess quality of life through the quality-of-life questionnaire through the Functional Assessment of Cancer Therapy - Breast [Baseline]
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.
Assess quality of life through the quality-of-life questionnaire through the Functional Assessment of Cancer Therapy - Breast [Follow up 2 month]
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.
Assess quality of life through the quality-of-life questionnaire through the Functional Assessment of Cancer Therapy - Breast [Follow up 4 month]
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.
Assess quality of life through the quality-of-life questionnaire through the Functional Assessment of Cancer Therapy - Breast [Follow up 6 month]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.