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NCT07084454: GAIN-S
Geriatric Oncology Care in Brazil: Remote Geriatric Assessment-Driven Interventions With Supportive Care
Phase 3 trial testing GAIN-S Multidisciplinary Telehealth Intervention in Geriatric Assessment in 350 participants. Enrolling by invitation.
30 November 2028
Quick facts
| Lead sponsor | Cristiane Decat Bergerot, PhD |
|---|---|
| Phase | Phase 3 |
| Status | ENROLLING BY INVITATION |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 350 |
| Start date | 6 December 2024 |
| Primary completion | 30 November 2028 |
| Estimated completion | 30 November 2028 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- GAIN-S Multidisciplinary Telehealth Intervention
- Standard Oncology Care
Conditions studied
- Geriatric Assessment — all drugs for Geriatric Assessment →
- Geriatric Oncology — all drugs for Geriatric Oncology →
- Quality of Life — all drugs for Quality of Life →
- Functional Decline — all drugs for Functional Decline →
Sponsor
Cristiane Decat Bergerot, PhD
Who can join
65 and older, any sex, with Geriatric Assessment or Geriatric Oncology. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07084454
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07084454 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cristiane Decat Bergerot, PhD
- Last refreshed: 24 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07084454.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing