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

NCT07084454 | Enrolling By Invitation Phase 3

• 2 other identifiers: InstitutoOncoclinicasCCR-24-200
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

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

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

Outcome Measures

Primary Outcomes (1)

• Change in Physical Function (Activities of Daily Living - ADL) Score

  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.

  Baseline to 3 months after treatment initiation

Secondary Outcomes (2)

• Change in Symptoms of Depression (Geriatric Depression Scale - GDS)

  Baseline to 3 months after treatment initiation

• Change in Health-Related Quality of Life (FACT-G Score)

  Baseline to 3 months after treatment initiation

Study Arms (2)

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.

Other: GAIN-S Multidisciplinary Telehealth Intervention

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.

Other: Standard Oncology Care

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.

Also known as: GAIN-S, Geriatric Assessment-Guided Intervention, Telehealth GAIN

GAIN-S Intervention Arm

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.

Also known as: Usual Care, SOC

Standard of Care (SOC) Arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cristiane Decat Bergerot, PhD: lead
• City of Hope Comprehensive Cancer Center: collaborator

Study Sites (1)

Instituto Oncoclinicas

Rio de Janeiro, Rio de Janeiro, 22250-905, Brazil

Location

Related Publications (7)

• 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. Epub 2018 May 21.

  PMID: 29782209 BACKGROUND

• 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 Guideline Update. J Clin Oncol. 2023 Sep 10;41(26):4293-4312. doi: 10.1200/JCO.23.00933. Epub 2023 Jul 17.

  PMID: 37459573 BACKGROUND

• 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):2095-2102. doi: 10.1002/cncr.34759. Epub 2023 Mar 25.

  PMID: 36964938 BACKGROUND

• 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 Netw. 2025 Jun;23(6):219-226. doi: 10.6004/jnccn.2025.7020.

  PMID: 40499588 BACKGROUND

• 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 BACKGROUND

• 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):1894-1904. doi: 10.1016/S0140-6736(21)01789-X. Epub 2021 Nov 3.

  PMID: 34741815 BACKGROUND

• 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/jamaoncol.2021.4158. Epub 2021 Nov 18.

  PMID: 34591080 BACKGROUND

Related Links

• This website provides a list of clinical trials currently being developed and conducted through the Cancer and Aging Research Group's Geriatric Oncology (CARG GOTO) program.

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label trial because: * Participants know if they are receiving the GAIN-S intervention. * The care providers and multidisciplinary team also know which arm the participant is in. * Masking is not feasible due to the nature of the intervention (telehealth and tailored supportive care).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Supportive Care

Model Details: This is a multicenter, two-arm, parallel-group randomized controlled trial. Participants are randomized in a 1:1 ratio to receive either a telehealth-delivered, geriatric assessment-guided multidisciplinary intervention (GAIN-S) or standard of care. Randomization is stratified by institution and disease stage (stage I-III vs. IV), using variable block sizes.

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 24, 2025
• Study Start: December 6, 2024
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: July 24, 2025

Record last verified: 2025-07

Locations

BR (1)