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

NCT07084454 · Status: ENROLLING_BY_INVITATION · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2025-07-24

No results posted yet for this 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.

Conditions

  • Geriatric Assessment
  • Geriatric Oncology
  • Quality of Life
  • Functional Decline
  • Depression
  • Aging
  • Supportive Care in Cancer
  • Activities of Daily Living

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.

Sponsors & Collaborators

  • City of Hope Comprehensive Cancer Center

    collaborator OTHER

  • Cristiane Decat Bergerot, PhD

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-06
Primary Completion
2028-11-30
Completion
2028-11-30

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07084454 on ClinicalTrials.gov