--- title: "Geriatric Oncology Care in Brazil: Remote Geriatric Assessment-Driven Interventions With Supportive Care" nct_id: NCT07084454 overall_status: ENROLLING_BY_INVITATION phase: PHASE3 sponsor: Cristiane Decat Bergerot, PhD study_type: INTERVENTIONAL primary_condition: Geriatric Assessment countries: Brazil canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07084454.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07084454" ct_last_update_post_date: 2025-07-24 last_seen_at: "2026-05-12T07:06:53.685Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Geriatric Oncology Care in Brazil: Remote Geriatric Assessment-Driven Interventions With Supportive Care **Official Title:** Geriatric Oncology Care in Brazil: Remote Geriatric Assessment-Driven Interventions With Supportive Care (The GAIN-S Trial in Brazil) **NCT ID:** [NCT07084454](https://clinicaltrials.gov/study/NCT07084454) ## Key Facts - **Status:** ENROLLING_BY_INVITATION - **Phase:** PHASE3 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 350 - **Lead Sponsor:** Cristiane Decat Bergerot, PhD - **Collaborators:** City of Hope Medical Center - **Conditions:** Geriatric Assessment, Geriatric Oncology, Quality of Life, Functional Decline, Depression, Aging, Supportive Care in Cancer, Activities of Daily Living - **Start Date:** 2024-12-06 - **Completion Date:** 2028-11-30 - **CT.gov Last Update:** 2025-07-24 ## Brief 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. ## Detailed Description This is a multicenter, randomized controlled trial evaluating the effectiveness of a telehealth-delivered, geriatric assessment-guided intervention (GAIN-S) in improving health outcomes for older adults with solid tumors who are initiating a new systemic cancer therapy (chemotherapy, immune checkpoint inhibitors, and/or tyrosine kinase inhibitors) in Brazil. The intervention is adapted from the Geriatric Assessment and Intervention Network (GAIN) model and integrates multidisciplinary supportive care services delivered remotely. The study is conducted across 14 oncology practices, including both private and public institutions, located in the Midwest, South, Southwest, and North regions of Brazil. A total of 350 participants aged 65 years and older will be enrolled and randomized 1:1 to either the GAIN-S intervention or standard of care (SOC). All participants will complete a validated geriatric assessment (CARG-GA) at baseline and again at 3 months. The CARG-GA evaluates functional status, comorbidities, psychological well-being, nutrition, cognitive status, social support, and fall risk. In the intervention arm (GAIN-S), patients will receive a tailored set of supportive care services based on their GA results. The multidisciplinary team-consisting of a medical oncologist, geriatrician, psychologist, psychiatrist, nutritionist, and exercise physiologist-will review the GA findings and deliver recommendations via telehealth (e.g., video calls or phone). Patients may receive one or more remote consultations from team members depending on their individual needs. In the SOC arm, GA results will be shared with the treating oncologist, but no structured intervention will be implemented unless a critical issue is identified (e.g., severe depression or cognitive impairment), in which case referrals may be made. The primary outcome is change in physical function (Activities of Daily Living - ADL) from baseline to 3 months. Secondary outcomes include changes in depression symptoms (Geriatric Depression Scale - GDS) and health-related quality of life (FACT-G) from baseline to 3 months. In addition to the main trial, a separate feasibility study will be conducted to evaluate the implementation of the GAIN-S intervention in public hospital settings. This feasibility study will recruit 50 patients from public hospitals in Brazil and will assess the practicality, acceptability, and potential barriers to delivering geriatric telehealth interventions in resource-limited environments. The study aims to address key gaps in cancer care delivery for older adults in low- and middle-income countries, where access to geriatric-trained oncology professionals is limited. The use of telehealth and standardized GA tools seeks to provide a scalable model for personalized care and improve outcomes in this underserved population. ## Eligibility - **Minimum age:** 65 Years - **Sex:** ALL - **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 ``` ## Arms - **GAIN-S Intervention Arm** (EXPERIMENTAL) — Participants in this arm will receive a telehealth-delivered, geriatric assessment (GA)-guided multidisciplinary supportive care intervention (GAIN-S). The intervention includes a comprehensive GA conducted remotely, with personalized recommendations reviewed by a multidisciplinary team (including oncologist, geriatrician, psychiatrist, psychologist, nutritionist, and fitness trainer). Patients will receive tailored supportive care consultations via telehealth, aiming to improve physical function, reduce depressive symptoms, and enhance quality of life during cancer treatment. - **Standard of Care (SOC) Arm** (ACTIVE_COMPARATOR) — Participants in this arm will receive the usual oncology care provided by their treating physicians. They will complete the geriatric assessment (GA) before treatment initiation, and the results will be made available to their oncologist. Referrals to supportive care services will be made at the physician's discretion based on GA findings. Patients will receive standard follow-up and management without the structured, multidisciplinary telehealth intervention provided in the GAIN-S arm. ## Interventions - **GAIN-S Multidisciplinary Telehealth Intervention** (OTHER) — 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** (OTHER) — 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. ## Primary Outcomes - **Change in Physical Function (Activities of Daily Living - ADL) Score** _(time frame: Baseline to 3 months after treatment initiation)_ — Physical function will be assessed by measuring changes in the Activities of Daily Living (ADL) score using the patient-reported portion of the CARG-GA. The primary objective is to determine if the GAIN-S intervention improves physical function compared to standard care. ## Secondary Outcomes - **Change in Symptoms of Depression (Geriatric Depression Scale - GDS)** _(time frame: Baseline to 3 months after treatment initiation)_ - **Change in Health-Related Quality of Life (FACT-G Score)** _(time frame: Baseline to 3 months after treatment initiation)_ ## Locations (1) - Instituto Oncoclinicas, Rio de Janeiro, Rio de Janeiro, Brazil ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `sponsor.collaborators` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.instituto oncoclinicas|rio de janeiro|rio de janeiro|brazil` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT07084454.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT07084454* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*