Geriatric AssessmentPhase 3GAIN-SNCT07084454
Geriatric Oncology Care in Brazil: Remote Geriatric Assessment-Driven Interventions With Supportive Care
A Phase 3 study testing GAIN-S Multidisciplinary Telehealth Intervention and Standard Oncology Care in people with Geriatric Assessment and Geriatric Oncology, run by Cristiane Decat Bergerot, PhD at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Geriatric Assessment, Geriatric Oncology, Quality of Life
- What is being tested?
- GAIN-S Multidisciplinary Telehealth Intervention and Standard Oncology Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteBrazil
- Study dates
- 6 Dec 2024to 30 Nov 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Geriatric Oncology Care in Brazil: Remote Geriatric Assessment-Driven Interventions With Supportive Care (The GAIN-S Trial in Brazil)
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?
Read more
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.
Read the 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.
- Conditions
- Geriatric Assessment, Geriatric Oncology, Quality of Life, Functional Decline, Depression, Aging
- Being tested
- GAIN-S Multidisciplinary Telehealth Intervention, Standard Oncology Care
- 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
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GAIN-S Multidisciplinary Telehealth InterventionOther
Also called GAIN-S, Geriatric Assessment-Guided Intervention, Telehealth GAIN
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 CareOther
Also called Usual Care, SOC
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard Oncology Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 3 months after treatment initiation
Secondary outcomes (2)
Change in Symptoms of Depression (Geriatric Depression Scale - GDS)
Depressive symptoms will be measured using the Geriatric Depression Scale (GDS). The study aims to evaluate whether the GAIN-S intervention reduces symptoms of depression compared to standard care.
Measured: Baseline to 3 months after treatment initiation
Change in Health-Related Quality of Life (FACT-G Score)
Quality of life will be measured by the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire. The study will assess if the intervention stabilizes or improves quality of life compared to standard care.
Measured: Baseline to 3 months after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start6 Dec 2024
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Geriatric AssessmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cristiane Decat Bergerot, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- City of Hope Medical Center
- Responsible party
- Sponsor-investigator, Cristiane Decat Bergerot, PhD, Instituto Oncoclinicas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084454
- Sponsor's protocol ID
- InstitutoOncoclinicas
- Other IDs
- CCR-24-200
- Acronym
- GAIN-S
- Status last verified
- Jul 2025
- First submitted
- 16 Jul 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision regarding sharing individual participant data (IPD) is currently under consideration. Factors such as participant privacy, ethical approvals, and logistical aspects will be evaluated before a final plan is established. Updates on data sharing intentions will be provided as the study progresses.
Publications
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.
PubMed 29782209Dale 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.
PubMed 37459573Bergerot 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.
PubMed 36964938Bergerot 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.
PubMed 40499588Soo 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.
PubMed 36102776Mohile 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.
PubMed 34741815Li 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.
PubMed 34591080
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Geriatric Oncology Care in Brazil: Remote Geriatric Assessment-Driven Interventions With Supportive Care (The GAIN-S Trial in Brazil)
- ClinicalTrials.gov ID
- NCT07084454
- Acronym / sponsor ID
- GAIN-S / InstitutoOncoclinicas
- Conditions
- Geriatric Assessment, Geriatric Oncology, Quality of Life, Functional Decline, Depression, Aging
- Keywords
- Geriatric Assessment, Geriatric Oncology, Older Adults with Cancer, Multidisciplinary Intervention, CARG-GA, Telehealth, Functional Status, Depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Cristiane Decat Bergerot, PhDUniversity, hospital or other
- Collaborators
- City of Hope Medical Center
- Study start
- 6 Dec 2024 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| GAIN-S Intervention Arm | Experimental | Other: GAIN-S Multidisciplinary Telehealth InterventionParticipants 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 | Other: Standard Oncology CareParticipants 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GAIN-S Multidisciplinary Telehealth InterventionAlso: GAIN-S, Geriatric Assessment-Guided Intervention, Telehealth GAINThis 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. | Other | GAIN-S Intervention Arm |
| Standard Oncology CareAlso: Usual Care, SOCParticipants 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. | Other | Standard of Care (SOC) Arm |
Primary outcome
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.
2 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Background: PubMed 29782209Mohile 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.
- Background: PubMed 37459573Dale 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.
- Background: PubMed 36964938Bergerot 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.
- Background: PubMed 40499588Bergerot 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.
- Background: PubMed 36102776Soo 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.
- Background: PubMed 34741815Mohile 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.
- Background: PubMed 34591080Li 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.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. The decision regarding sharing individual participant data (IPD) is currently under consideration. Factors such as participant privacy, ethical approvals, and logistical aspects will be evaluated before a final plan is established. Updates on data sharing intentions will be provided as the study progresses.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GAIN-S Multidisciplinary Telehealth Intervention and Standard Oncology Care in people with Geriatric Assessment and Geriatric Oncology, run by Cristiane Decat Bergerot, PhD at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physical Function (Activities of Daily Living - ADL) Score (time frame: Baseline to 3 months after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07084454, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.