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Clinical Trials in Brazil / NCT07084454
Enrolling by invitation Phase 3

Geriatric Oncology Care in Brazil: Remote Geriatric Assessment-Driven Interventions With Supportive Care

NCT07084454 · tracked via the Priya Life Science Brazil tracker
Sponsor
Cristiane Decat Bergerot, PhD
Phase
Phase 3
Started
2024-12-06
Last updated
2025-07-24

Condition(s) studied

Geriatric AssessmentGeriatric OncologyQuality of LifeFunctional DeclineDepressionAgingSupportive Care in CancerActivities of Daily Living

Investigational drug(s) / intervention(s)

GAIN-S Multidisciplinary Telehealth InterventionStandard Oncology Care

GAIN-S Multidisciplinary Telehealth Intervention: This intervention delivers a comprehensive geriatric assessment (GA) via telehealth to older adults with cancer. Based on the GA results, a multidisciplinary team including oncologists, geriatricians, psychiatrists, psychologists, nutritionists, and certified fitness trainers provide personalized supportive care recommendations and consultations remotely. The goal is to improve physical function, reduce depressive symptoms, and enhance quality of life during cancer treatment.

Standard Oncology Care: Participants receive the usual oncology care provided by their treating physicians without a structured geriatric assessment-driven intervention. Geriatric assessment results are shared with the treating oncologist, who may refer patients to supportive care services based on clinical judgment. No coordinated multidisciplinary telehealth intervention is provided.

Study summary

The goal of this clinical trial is to determine whether a telehealth-delivered, geriatric assessment-guided supportive care program (GAIN-S) can improve health outcomes in older adults (age 65 and above) with solid tumors who are starting a new cancer treatment in Brazil. The main questions it aims to answer are:

* Does GAIN-S improve physical function, as measured by activities of daily living (ADL), after three months?
* Does GAIN-S reduce symptoms of depression and improve quality of life after three months?

Researchers will compare patients receiving the GAIN-S intervention to those receiving standard care to see if the intervention leads to better physical function, fewer symptoms of depression, and improved quality of life.

Participants will:

* Complete a geriatric assessment (CARG-GA) before and after treatment.
* Be randomized to either standard care or the GAIN-S intervention.
* If assigned to GAIN-S, receive tailored supportive care via telehealth, which may include consultations with a psychologist, psychiatrist, nutritionist, geriatrician, exercise physiologist, or other specialists based on their needs.

Eligibility

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age 65 years or older at time of enrollment * Diagnosed with a solid tumor cancer of any stage * Scheduled to start a new systemic cancer therapy (chemotherapy, immune checkpoint inhibitors, and/or tyrosine kinase inhibitors) * Able to provide written informed consent * Physician approval for participation Exclusion Criteria: * Inability or unwillingness to comply with study procedures, including telehealth visits * Cognitive or other impairments precluding participation as determined by the investigator * Any condition that, in the investigator's opinion, would make the patient unsuitable for the study or interfere with study assessments

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Instituto Oncoclinicas Rio de Janeiro Rio de Janeiro

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07084454 on ClinicalTrials.gov ↗ ← All trials in Brazil