Back to resultsWearable Enhanced Fitness Tracking for Metastatic Breast Cancer Patients Using Endocrine Treatment and Palbociclib (WEFITTER)
Primary Purpose
Breast Neoplasm Female, Quality of Life
Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Use of the WeCancer app combined with the smartwatch.
Sponsored by
About this trial
This is an interventional other trial for Breast Neoplasm Female focused on measuring Quality of life, Metastatic breast cancer, Metastasis, Exercise, Palbociclib
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.
Sites / Locations
- OncoclínicasRecruiting
- A Beneficência Portuguesa de São PauloRecruiting
- A.C.Camargo Cancer CenterRecruiting
- Centro Paulista de OncologiaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Use of the WeCancer app combined with the smartwatch
Using the WeCancer app
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05277935
First Posted
January 12, 2022
Last Updated
July 28, 2023
Sponsor
Beneficência Portuguesa de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT05277935
Brief Title
Wearable Enhanced Fitness Tracking for Metastatic Breast Cancer Patients Using Endocrine Treatment and Palbociclib
Acronym
WEFITTER
Official Title
Wearable Enhanced Fitness Tracking for Metastatic Breast Cancer Patients Using Endocrine Treatment and Palbociclib
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 22, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beneficência Portuguesa de São Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm Female, Quality of Life
Keywords
Quality of life, Metastatic breast cancer, Metastasis, Exercise, Palbociclib
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Use of the WeCancer app combined with the smartwatch
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Using the WeCancer app
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Use of the WeCancer app combined with the smartwatch.
Intervention Description
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
Primary Outcome Measure Information:
Title
Assess quality of life through the quality-of-life questionnaire through the Functional Assessment of Cancer Therapy - Breast
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 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.
Time Frame
Baseline
Title
Assess quality of life through the quality-of-life questionnaire through the Functional Assessment of Cancer Therapy - Breast
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 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.
Time Frame
Follow up 2 month
Title
Assess quality of life through the quality-of-life questionnaire through the Functional Assessment of Cancer Therapy - Breast
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 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.
Time Frame
Follow up 4 month
Title
Assess quality of life through the quality-of-life questionnaire through the Functional Assessment of Cancer Therapy - Breast
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 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.
Time Frame
Follow up 6 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bianca Verboski
Phone
11-35052639
Ext
55
Email
naipe@bp.org.br
First Name & Middle Initial & Last Name or Official Title & Degree
Bianca Verboski
Phone
11-35052639
Ext
55
Email
bianca.verboski@bp.org.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Graziela Dal Molin, MD
Organizational Affiliation
Beneficência Portuguesa de São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oncoclínicas
City
Rio De Janeiro
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mayara Pinto
Phone
+55 11 97144-5373
Email
mayara.pinto@oncoclinicas.com
First Name & Middle Initial & Last Name & Degree
Aline Gonçalves, MD
Facility Name
A Beneficência Portuguesa de São Paulo
City
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bianca Verboski
Phone
+551135055031
Email
bianca.verboski@bp.org.br
First Name & Middle Initial & Last Name & Degree
Jessica Borges
Phone
+551135055722
Email
naipe@bp.org.br
First Name & Middle Initial & Last Name & Degree
Graziela Dal Molin, MD
Facility Name
A.C.Camargo Cancer Center
City
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcelle Goldner Cesca, MD
Phone
+55 11 93148-9664
Email
marcelle.goldner@gmail.com
First Name & Middle Initial & Last Name & Degree
Solange Moraes Sanches, MD
Facility Name
Centro Paulista de Oncologia
City
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mayara Batista
Phone
+55 11 2678-5800
Ext
5433
Email
mayara.pinto@oncoclinicas.com
First Name & Middle Initial & Last Name & Degree
Larissa Gomes, MD
12. IPD Sharing Statement
Learn more about this trial
Wearable Enhanced Fitness Tracking for Metastatic Breast Cancer Patients Using Endocrine Treatment and Palbociclib
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