Recruiting NCT05277935
Wearable Enhanced Fitness Tracking for Metastatic Breast Cancer Patients Using Endocrine Treatment and Palbociclib
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Use of the WeCancer app combined with the smartwatch..
- Who it may be relevant to
- Registry conditions: Breast Neoplasm Female, Quality of Life. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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
Primary outcome measures
- Assess quality of life through the quality-of-life questionnaire through the Functional Assessment of Cancer Therapy - Breast [Time frame: 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]
- Assess quality of life through the quality-of-life questionnaire through the Functional Assessment of Cancer Therapy - Breast [Time frame: 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Brazil · 4 centers
- Oncoclínicas — Rio de Janeiro
- A Beneficência Portuguesa de São Paulo — São Paulo
- A.C.Camargo Cancer Center — São Paulo
- Centro Paulista de Oncologia — São Paulo
Identifiers
NCT: NCT05277935 · WEFITTER