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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое 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.

Первичные конечные точки

• Change in Physical Function (Activities of Daily Living - ADL) Score [Срок оценки: Baseline to 3 months after treatment initiation]

Вторичные конечные точки (2)

• Change in Symptoms of Depression (Geriatric Depression Scale - GDS) [Срок оценки: Baseline to 3 months after treatment initiation]
• Change in Health-Related Quality of Life (FACT-G Score) [Срок оценки: Baseline to 3 months after treatment initiation]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Бразилия · 1 центр

• Instituto Oncoclinicas — Rio de Janeiro

Публикации

• Mohile SG, Dale W, Somerfield MR, Schonberg MA, Boyd CM, Burhenn PS, Canin B, Cohen HJ, Holmes HM, Hopkins JO, Janelsins MC, Khorana AA, Klepin HD, Lichtman SM, Mustian KM, Tew WP, Hurria A. Practical Assessment and Management of Vulnerabilities in Older Patients Receiving Chemotherapy: ASCO Guideline for Geriatric Oncology. J Clin Oncol. 2018 Aug 1;36(22):2326-2347. doi: 10.1200/JCO.2018.78.8687. PMID 29782209
• Dale W, Klepin HD, Williams GR, Alibhai SMH, Bergerot C, Brintzenhofeszoc K, Hopkins JO, Jhawer MP, Katheria V, Loh KP, Lowenstein LM, McKoy JM, Noronha V, Phillips T, Rosko AE, Ruegg T, Schiaffino MK, Simmons JF Jr, Subbiah I, Tew WP, Webb TL, Whitehead M, Somerfield MR, Mohile SG. Practical Assessment and Management of Vulnerabilities in Older Patients Receiving Systemic Cancer Therapy: ASCO Gui PMID 37459573
• Bergerot CD, Bergerot PG, Razavi M, Philip EJ, Lakhdari S, Franca MVDS, Molina LNM, Freitas ANS, Taveira MC, de Azeredo AC, Fuzita WH, Fernandes CM, Pio RB, de Araujo R, Couto MM, de Vasconcellos VF, Nonino MF, Lee D, de Matos Neto JN, Buso MM, Soto-Perez-de-Celis E, Dale W. Implementation and evaluation of a remote geriatric assessment and intervention program in Brazil. Cancer. 2023 Jul 1;129(13 PMID 36964938
• Bergerot CD, Bergerot PG, Razavi M, Franca MVDS, da Silva JRG, Cerveira JA, Fuzita WH, de Azeredo AC, Dos Anjos GM, de Vasconcellos VF, Philip EJ, de Matos Neto JN, Canedo JF, Laloni MT, Ferreira CGM, Buso MM, Pal SK, Nipp R, El-Jawahri A, Soto-Perez-de-Celis E, Dale W. Telehealth Geriatric Assessment and Supportive Care Intervention (GAIN-S) Program: A Randomized Clinical Trial. J Natl Compr Canc PMID 40499588
• Soo WK, King MT, Pope A, Parente P, Darzins P, Davis ID. Integrated Geriatric Assessment and Treatment Effectiveness (INTEGERATE) in older people with cancer starting systemic anticancer treatment in Australia: a multicentre, open-label, randomised controlled trial. Lancet Healthy Longev. 2022 Sep;3(9):e617-e627. doi: 10.1016/S2666-7568(22)00169-6. Epub 2022 Aug 22. PMID 36102776
• Mohile SG, Mohamed MR, Xu H, Culakova E, Loh KP, Magnuson A, Flannery MA, Obrecht S, Gilmore N, Ramsdale E, Dunne RF, Wildes T, Plumb S, Patil A, Wells M, Lowenstein L, Janelsins M, Mustian K, Hopkins JO, Berenberg J, Anthony N, Dale W. Evaluation of geriatric assessment and management on the toxic effects of cancer treatment (GAP70+): a cluster-randomised study. Lancet. 2021 Nov 20;398(10314):189 PMID 34741815
• Li D, Sun CL, Kim H, Soto-Perez-de-Celis E, Chung V, Koczywas M, Fakih M, Chao J, Cabrera Chien L, Charles K, Hughes SFDS, Katheria V, Trent M, Roberts E, Jayani R, Moreno J, Kelly C, Sedrak MS, Dale W. Geriatric Assessment-Driven Intervention (GAIN) on Chemotherapy-Related Toxic Effects in Older Adults With Cancer: A Randomized Clinical Trial. JAMA Oncol. 2021 Nov 1;7(11):e214158. doi: 10.1001/ja PMID 34591080

Идентификаторы

NCT: NCT07084454 · InstitutoOncoclinicas · CCR-24-200

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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