Clinical trial · Interventional
Geriatric Oncology Care in Brazil: Remote Geriatric Assessment-Driven Interventions With Supportive Care
Geriatric Oncology Care in Brazil: Remote Geriatric Assessment-Driven Interventions With Supportive Care (The GAIN-S Trial in Brazil)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Activities of Daily Living | — | UNRESOLVED | — |
| Aging | — | UNRESOLVED | — |
| Depression | — | UNRESOLVED | — |
| Functional Decline | — | UNRESOLVED | — |
| Geriatric Assessment | — | UNRESOLVED | — |
| Geriatric Oncology | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Supportive Care in Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GAIN-S Multidisciplinary Telehealth Intervention | Other | — | UNRESOLVED |
| Standard Oncology Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- GAIN-S Intervention Arm
- description
- 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.
- interventionNames
- Other: GAIN-S Multidisciplinary Telehealth Intervention
- type
- ACTIVE_COMPARATOR
- label
- Standard of Care (SOC) Arm
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
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
References
Publications (7)
- BACKGROUNDMohile 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
- BACKGROUNDDale 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
- BACKGROUNDBergerot 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
- BACKGROUNDBergerot 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
- BACKGROUNDSoo 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.