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ENROLLING BY INVITATION
NCT07084454
PHASE3

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

Sponsor: Cristiane Decat Bergerot, PhD

View on ClinicalTrials.gov

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.

Official title: Geriatric Oncology Care in Brazil: Remote Geriatric Assessment-Driven Interventions With Supportive Care (The GAIN-S Trial in Brazil)

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

350

Start Date

2024-12-06

Completion Date

2028-11-30

Last Updated

2025-07-24

Healthy Volunteers

No

Interventions

OTHER

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.

OTHER

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.

Locations (1)

Instituto Oncoclinicas

Rio de Janeiro, Rio de Janeiro, Brazil