- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05277935
Wearable Enhanced Fitness Tracking for Metastatic Breast Cancer Patients Using Endocrine Treatment and Palbociclib (WEFITTER)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bianca Verboski
- Phone Number: 55 11-35052639
- Email: naipe@bp.org.br
Study Contact Backup
- Name: Bianca Verboski
- Phone Number: 55 11-35052639
- Email: bianca.verboski@bp.org.br
Study Locations
-
-
-
Rio De Janeiro, Brazil
- Recruiting
- Oncoclínicas
-
Contact:
- Mayara Pinto
- Phone Number: +55 11 97144-5373
- Email: mayara.pinto@oncoclinicas.com
-
Sub-Investigator:
- Aline Gonçalves, MD
-
São Paulo, Brazil
- Recruiting
- A Beneficência Portuguesa de São Paulo
-
Contact:
- Bianca Verboski
- Phone Number: +551135055031
- Email: bianca.verboski@bp.org.br
-
Contact:
- Jessica Borges
- Phone Number: +551135055722
- Email: naipe@bp.org.br
-
Principal Investigator:
- Graziela Dal Molin, MD
-
São Paulo, Brazil
- Recruiting
- A.C.Camargo Cancer Center
-
Contact:
- Marcelle Goldner Cesca, MD
- Phone Number: +55 11 93148-9664
- Email: marcelle.goldner@gmail.com
-
Principal Investigator:
- Solange Moraes Sanches, MD
-
São Paulo, Brazil
- Recruiting
- Centro Paulista de Oncologia
-
Contact:
- Mayara Batista
- Phone Number: 5433 +55 11 2678-5800
- Email: mayara.pinto@oncoclinicas.com
-
Principal Investigator:
- Larissa Gomes, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess quality of life through the quality-of-life questionnaire through the Functional Assessment of Cancer Therapy - Breast
Time Frame: 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. |
Baseline
|
Assess quality of life through the quality-of-life questionnaire through the Functional Assessment of Cancer Therapy - Breast
Time Frame: 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. |
Follow up 2 month
|
Assess quality of life through the quality-of-life questionnaire through the Functional Assessment of Cancer Therapy - Breast
Time Frame: 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. |
Follow up 4 month
|
Assess quality of life through the quality-of-life questionnaire through the Functional Assessment of Cancer Therapy - Breast
Time Frame: 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. |
Follow up 6 month
|
Collaborators and Investigators
Investigators
- Principal Investigator: Graziela Dal Molin, MD, Beneficencia Portuguesa de Sao Paulo
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WEFITTER
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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