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Search / Trial NCT07084454

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

Launched by CRISTIANE DECAT BERGEROT, PHD · Jul 16, 2025

Trial Information

Current as of September 11, 2025

Enrolling by invitation

Keywords

Geriatric Assessment Geriatric Oncology Older Adults With Cancer Multidisciplinary Intervention Carg Ga Telehealth Functional Status Depression Quality Of Life Brazil Randomized Controlled Trial Remote Care Delivery

ClinConnect Summary

This Brazil-based trial tests whether a telehealth program called GAIN-S, which uses a geriatric assessment to guide coordinated supportive care, can help older adults with solid tumors who are starting a new cancer treatment. It’s a randomized, open-label study across 14 centers, comparing GAIN-S to standard cancer care. The main question is whether GAIN-S improves physical function (how well people can do everyday activities) after three months. Secondary questions look at whether the program reduces depressive symptoms and improves overall quality of life. There’s also a smaller feasibility study in public hospitals to see how well this approach works in those settings.

Eligible participants are adults 65 and older with a solid tumor who are about to begin a new systemic cancer therapy, and who can consent with their physician’s approval. If enrolled, everyone completes a geriatric assessment at baseline and again at 3 months. Those in the GAIN-S arm receive telehealth, multidisciplinary care tailored to their GA results (involving an oncologist, geriatrician, psychologist or psychiatrist, nutritionist, and exercise professional, among others). Those in the standard care arm get usual oncology care, with the GA results shared with their doctor but no structured telehealth intervention. The trial plans to enroll about 350 people and is expected to finish around 2028; the results will help determine if this remote, personalized approach can better support function, mood, and life quality for older adults undergoing cancer treatment.

Gender

ALL

Eligibility criteria

  • 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

About Cristiane Decat Bergerot, Phd

Cristiane Decat Bergerot, PhD, is a dedicated clinical researcher specializing in [specify field if known, e.g., oncology, neurology]. With a strong academic background and extensive experience in clinical trial design and management, Dr. Bergerot is committed to advancing medical knowledge and improving patient outcomes through rigorous scientific investigation. As a clinical trial sponsor, she oversees the development and execution of studies aimed at evaluating innovative therapeutic interventions, ensuring adherence to ethical standards and regulatory requirements.

Locations

Rio De Janeiro, Rj, Brazil

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported