Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2023-03-02
2028-01-31
Brief Summary
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Detailed Description
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To do this, the investigators will rely on the first of the high-definition medicine strategies and evaluate the main health determinants of each individual.
This strategy will be use because by obtaining a personal baseline from a sufficiently large cohort of patients the investigators will be able to interrelate and identify those variables that have greater weight when it comes to obtaining a response or good tolerance to oncological treatment.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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First line breast cancer metastatic subtype luminal
Women with hormone-positive, HER2-negative breast cancer who will receive CDK4/6 inhibitor plus hormone treatment.
Wearable
Continuous monitoring thought data recorded with wearable (Vivosmart Garmin bracelet)
First line colon cancer metastatic
Women with colon cancer of any subtype, candidates to receive first-line treatment.
Wearable
Continuous monitoring thought data recorded with wearable (Vivosmart Garmin bracelet)
First line lung cancer metastatic
Women with lung cancer of any subtype, candidates to receive first-line treatment.
Wearable
Continuous monitoring thought data recorded with wearable (Vivosmart Garmin bracelet)
Interventions
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Wearable
Continuous monitoring thought data recorded with wearable (Vivosmart Garmin bracelet)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Advanced tumor stage (III or IV) not a candidate for treatment with curative intent.
* Preference will be given to the following pathologies and sub-types:
* Women with hormone-positive, HER2-negative breast cancer who will receive a CDK4/6 inhibitor plus a hormone inhibitor. o Women with lung cancer of any subtype, candidates to receive first-line treatment.
* Women with colon cancer of any subtype, candidates to receive first-line treatment.
* Patients who are going to start treatment in a clinical trial are allowed, as long as the treatment is known (in other words, patients who participate in double-blind studies would not be candidates). There are no inclusion problems for patients who have different types of therapies within the trial as long as they are known (examples such as the following, but not limited to these: women starting treatment for breast cancer with a SERD and an approved CDK4/6 inhibitor , women who start an AI and an experimental CDK4/6/2, women who start a triplet for breast cancer but include AI+CDK4/6i, women who start a triplet for lung cancer with chemotherapy, pembrolizumab, and an experimental immunotherapy , etc).
* ECOG performance status \<2.
* Sufficient capacity and knowledge to carry and use the wearable.
* Have a mobile device with internet access and an email account.
* Ability to complete quality of life, nutrition and mental health questionnaires.
* Written informed consent to participate in the trial obtained prior to any study-specific screening procedures.
* Patients with co-morbidities are not excluded - they are part of the "real world" clinic and it is necessary to know their evolution.
* For the same reason, pregnant women are not excluded.
Exclusion Criteria
* Planned participation in treatment in a double-blind trial regime.
* Previous or concomitant malignant disease of any other type that could affect compliance with the protocol or interpretation of results. Patients with curatively treated basal cell carcinoma of the skin or cervical cancer in situ are eligible for the study.
* Concurrent illnesses that may significantly interfere with participation in the study at the discretion of the investigator. No specific diseases are specified, since patients with multiple pathologies are part of the daily clinic and it is very interesting to collect data from patients with other comorbidities, as long as they have the necessary digital familiarization to wear the wearable and use the APP.
* Carriers of therapeutic electronic devices: pacemakers, defibrillators or cardiac resynchronizers (due to potential interference caused by the device).
18 Years
FEMALE
No
Sponsors
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Centro Nacional de Investigaciones Oncologicas CARLOS III
OTHER
Responsible Party
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Principal Investigators
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Miguel A Quintela, PhD
Role: PRINCIPAL_INVESTIGATOR
CNIO- Spanish Research Cancer Center
Locations
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Hospital Universitario A Coruña
A Coruña, A Coruña/ Galicia, Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, Spain
Hospital Son Espases
Palma de Mallorca, Mallorca / Baleares, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain
Hospital Virgen de la Macarena
Seville, Sevilla/ Andalucia, Spain
ICO Hospitalet Bellvitge
Barcelona, , Spain
Hospital San Pedro Alcántara de Cáceres
Cáceres, , Spain
Hospital de La Princesa
Madrid, , Spain
Hospital General de Valencia
Valencia, , Spain
Countries
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Central Contacts
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Facility Contacts
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Begoña Bermejo de las Heras, MD
Role: primary
Other Identifiers
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PMP22/00032
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
High Definition Medicine PMP22
Identifier Type: -
Identifier Source: org_study_id
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