Hematopoietic and Lymphoid System NeoplasmNCT06022965
Telemedicine for Improvement of Care for Older Adults With Cancer in the Underserved Community, The GAIN-S Trial
A study testing Best Practice, Comprehensive Geriatric Assessment and Electronic Health Record Review in people with Hematopoietic and Lymphoid System Neoplasm and Malignant Solid Neoplasm, run by City of Hope Medical Center at 3 sites in United States.
Trial summary
This clinical trial evaluates whether geriatric assessment-driven interventions with supportive care (GAIN-S) using telemedicine can be used to identify areas of vulnerability (weakness) in older adults with cancer and guide interventions to assist the patient and the healthcare team in the underserved community. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Best Practice, Comprehensive Geriatric Assessment and Electronic Health Record Review
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Aug 2023to 24 Jan 2027
- Phase
- Interventional
- 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
- Documented informed consent of the participant.
- Patient's physician must agree for patient participation.
- Ability to read English, Spanish, or Chinese. Other languages will be acceptable with site principal investigator (PI) agreement if surveys are available, and language does not preclude completing study procedures.
- Age: >=65 years at the time of enrollment.
- Diagnosis of stage I-IV cancer.
- Scheduled to start a new therapy (chemotherapy, immunotherapy, or targeted therapy).
Who cannot join
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics).
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
City of Hope Medical Center
Duarte, California, 91010
William Dale, 626-256-4673, wdale@coh.org
William Dale
- Recruiting
City of Hope Antelope Valley
Lancaster, California, 93534
William Dale, 626-256-4673, wdale@coh.org
William Dale
- Recruiting
City of Hope Upland
Upland, California, 91786
William Dale, 626-256-4673, wdale@coh.org
William Dale
About this study
Official title: Geriatric Assessment (GA)-Driven Interventions With Supportive Care (The GAIN-S Trial): Telemedicine to Increase Goal Concordant Care for Older Adults With Cancer in the Community
This clinical trial evaluates whether geriatric assessment-driven interventions with supportive care (GAIN-S) using telemedicine can be used to identify areas of vulnerability (weakness) in older adults with cancer and guide interventions to assist the patient and the healthcare team in the underserved community. The majority of patients diagnosed with cancer are over age 65 years, yet most cancer treatments are developed and tested in a younger population. Therefore, older patients with cancer are less likely to be offered standard treatments because of the concern regarding side effects. Geriatric assessment (GA) is a multi-dimensional health assessment tool combining patient reported and objective (unbiased) results. There is no standard tool that can identify which older adults will be more likely to have side effects from cancer treatment. Telemedicine is a way to provide healthcare services (including consultations, education, care management and treatment) in which the health care provider is at a distant site. The goal of this project is to use telemedicine to identify areas of vulnerability/weakness in older adults with cancer using a patient assessment, and to identify the potential referrals to a multi-specialty team based on patient assessment results. Information gathered from this study may help researchers learn whether GAIN-S can be performed using telemedicine and lead to improvement in care for older adults compared to standard of care (SOC) in the underserved community.
Read the detailed description
PRIMARY OBJECTIVES:
- To implement Geriatric Assessment-driven interventions with supportive care (GAIN-S) through telemedicine to:
Ia. To improve communication between the primary care team (oncologist, nurses) and patients and caregivers in a remote community setting to increase prognostic discussions and goal concordant care; Ib. To improve cost-saving in older patients with cancer.
SECONDARY OBJECTIVES:
- Determine whether GAIN-S implemented in a community setting will lead to a decrease in treatment toxicity.
II. To examine whether GAIN-S intervention will lead to improvement in hospitalizations, dose delays, dose reduction and discontinuation.
III. To compare patient satisfaction using the "Was It Worth It" (WIWI) between the 2 arms at the 3 and/or 6-month timepoint.
IV. To compare patient preferences at baseline, using the validated patient-defined treatment preference and goals measures between the 2 arms and longitudinal change, at 3 and/or 6-month timepoint.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (GAIN-S): Patients complete the Cancer and Aging Research Group-Geriatric Assessment (CARG-GA) at baseline and 3 months and receive GA-based interventions using telemedicine over 6 months.
ARM II (SOC): Patients complete the CARG-GA at baseline and 3 months and receive SOC over 6 months.
- Being tested
- Best Practice, Comprehensive Geriatric Assessment, Electronic Health Record Review, Questionnaire Administration, Supportive Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive SOC
Comprehensive Geriatric AssessmentOther
Complete CARG-GA
Electronic Health Record ReviewOther
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Supportive CareOther
Also called Supportive Therapy, Symptom Management, Therapy, Supportive
Receive GA-based interventions
TelemedicineOther
Also called Telehealth
Receive GA-based interventions via telemedicine
| Study group | Role | What they receive |
|---|---|---|
| ARM I (GAIN-S) | Experimental | Patients complete the CARG-GA at baseline and 3 months and receive GA-based interventions using telemedicine over 6 months. Receives: Other: Best Practice; Other: Comprehensive Geriatric Assessment; Other: Electronic Health Record Review; Other: Questionnaire Administration; Other: Supportive Care; Other: Telemedicine |
| ARM II (SOC) | Active comparator | Receive SOC over the first 3 months, then switch to receive GA-based interventions using telemedicine for the following 3 months.
Patients complete the CARG-GA at baseline and 3 months and receive SOC over 6 months. Receives: Other: Best Practice; Other: Comprehensive Geriatric Assessment; Other: Electronic Health Record Review; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of advance directive (AD) completion
Will be assessed using medical chart review. Chi-square test will be used to compare the proportions of AD completion between the two arms.
Measured: At start of treatment and 3 months after treatment initiation
Number of documented conversations.
Will be assessed using medical chart review. T-test will be used to compare the mean number of documented conversations between the two arms.
Measured: At start of treatment and 3 months after treatment initiation
Direct inpatient cost
Will log transformed and Z-score test will be used to compare the mean costs of the two arms. Chi-square test will be used to compare number of patients with short verse (vs.) long stay and Intensive Care Unit (ICU) admission between the two arms.
Measured: At 3 and 6-months after treatment initiation
Secondary outcomes (5)
Decrease in treatment toxicity
Will be described using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and will examine toxicities by grade and type. Chi-square test will be used to compare proportion of patients with grade 3-5 toxicity, dose modifications including dose change, dose delay, discontinuation as well as hospitalization, consider treatment worthwhile between two arms.
Measured: At 3 months after randomization
Proportion of patients with dose modifications
Defined as delays and dose change experienced by patients for each cohort at each cycle. The reason for dose modifications will be noted and attributed as possibly, probably, or definitely related to treatment. Chi-square test will be used to compare proportion of patients with grade 3-5 toxicity, dose modifications including dose change, dose delay, discontinuation as well as hospitalization, consider treatment worthwhile between two arms.
Measured: Up to 6 months
Patient satisfaction using the "Was It Worth It" (WIWI)
Patient satisfaction assessed as whether patients found treatment worthwhile using the "Was it Worth it" (WIWI) questionnaire.
T-test will be used to compare satisfaction rating between the two arms. Chi-square test will be used to compare proportion of patients consider treatment worthwhile between the two groups.
Measured: At 3 and/or 6-months after treatment initiation
Patient preferences and goals
Patient-Defined Treatment Preferences and Goals will be measured utilizing the Health Outcomes Questionnaire, Now vs Later Tool and Attitude Scale. Will use the validated patient-defined treatment preference and goals measures between the 2 arms and longitudinal change. Descriptive statistics and plots will be used to describe and compare of longitudinal changes in patient preferences and goals will be plotted.
Measured: At baseline, 3 and/or 6 months after treatment initiation
Association of Community Cancer Centers (ACCC) Geriatric Oncology Gap Assessment Tool
The tool's name is: Association of Community Cancer Centers: Geriatric Oncology Gap Assessment Tool Scoring for the tool is based on a 1-4 scale with Level 4 representing the optimal practice.
Prior to study initiation, each site will be quantitatively evaluated utilizing the evidence-based ACCC Geriatric Oncology Gap Assessment tool; each site would be reassessed at the end of the study. This tool will provide an evidence-based assessment to evaluate the current geriatric oncology efforts at each site and guide future steps for improvement to these services.
Measured: Baseline and at the end of study (36 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start10 Aug 2023
- Primary completion24 Jan 2027 (estimated)
- Study completion24 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid System NeoplasmStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- William Dale, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06022965
- Sponsor's protocol ID
- 22343
- Other IDs
- NCI-2023-05945, 22343, P30CA033572
- Status last verified
- Oct 2026
- First submitted
- 21 Aug 2023
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Geriatric Assessment (GA)-Driven Interventions With Supportive Care (The GAIN-S Trial): Telemedicine to Increase Goal Concordant Care for Older Adults With Cancer in the Community
- ClinicalTrials.gov ID
- NCT06022965
- Acronym / sponsor ID
- 22343
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 24 Jan 2027 (estimated)
- Study completion
- 24 Jan 2027 (estimated)
- First posted
- 5 Sep 2023 (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.
This clinical trial evaluates whether geriatric assessment-driven interventions with supportive care (GAIN-S) using telemedicine can be used to identify areas of vulnerability (weakness) in older adults with cancer and guide interventions to assist the patient and the healthcare team in the underserved community. The majority of patients diagnosed with cancer are over age 65 years, yet most cancer treatments are developed and tested in a younger population. Therefore, older patients with cancer are less likely to be offered standard treatments because of the concern regarding side effects. Geriatric assessment (GA) is a multi-dimensional health assessment tool combining patient reported and objective (unbiased) results. There is no standard tool that can identify which older adults will be more likely to have side effects from cancer treatment. Telemedicine is a way to provide healthcare services (including consultations, education, care management and treatment) in which the health care provider is at a distant site. The goal of this project is to use telemedicine to identify areas of vulnerability/weakness in older adults with cancer using a patient assessment, and to identify the potential referrals to a multi-specialty team based on patient assessment results. Information gathered from this study may help researchers learn whether GAIN-S can be performed using telemedicine and lead to improvement in care for older adults compared to standard of care (SOC) in the underserved community.
Detailed description
PRIMARY OBJECTIVES:
- To implement Geriatric Assessment-driven interventions with supportive care (GAIN-S) through telemedicine to:
Ia. To improve communication between the primary care team (oncologist, nurses) and patients and caregivers in a remote community setting to increase prognostic discussions and goal concordant care; Ib. To improve cost-saving in older patients with cancer.
SECONDARY OBJECTIVES:
- Determine whether GAIN-S implemented in a community setting will lead to a decrease in treatment toxicity.
II. To examine whether GAIN-S intervention will lead to improvement in hospitalizations, dose delays, dose reduction and discontinuation.
III. To compare patient satisfaction using the "Was It Worth It" (WIWI) between the 2 arms at the 3 and/or 6-month timepoint.
IV. To compare patient preferences at baseline, using the validated patient-defined treatment preference and goals measures between the 2 arms and longitudinal change, at 3 and/or 6-month timepoint.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (GAIN-S): Patients complete the Cancer and Aging Research Group-Geriatric Assessment (CARG-GA) at baseline and 3 months and receive GA-based interventions using telemedicine over 6 months.
ARM II (SOC): Patients complete the CARG-GA at baseline and 3 months and receive SOC over 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM I (GAIN-S) | Experimental | Other: Best Practice, Other: Comprehensive Geriatric Assessment, Other: Electronic Health Record Review, Other: Questionnaire Administration, Other: Supportive Care, Other: TelemedicinePatients complete the CARG-GA at baseline and 3 months and receive GA-based interventions using telemedicine over 6 months. |
| ARM II (SOC) | Active comparator | Other: Best Practice, Other: Comprehensive Geriatric Assessment, Other: Electronic Health Record Review, Other: Questionnaire AdministrationReceive SOC over the first 3 months, then switch to receive GA-based interventions using telemedicine for the following 3 months. Patients complete the CARG-GA at baseline and 3 months and receive SOC over 6 months. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Documented informed consent of the participant.
- Patient's physician must agree for patient participation.
- Ability to read English, Spanish, or Chinese. Other languages will be acceptable with site principal investigator (PI) agreement if surveys are available, and language does not preclude completing study procedures.
- Age: >=65 years at the time of enrollment.
- Diagnosis of stage I-IV cancer.
Key exclusion criteria (1 listed)
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics).
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 |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive SOC | Other | ARM I (GAIN-S), ARM II (SOC) |
| Comprehensive Geriatric AssessmentComplete CARG-GA | Other | ARM I (GAIN-S), ARM II (SOC) |
| Electronic Health Record ReviewAncillary studies | Other | ARM I (GAIN-S), ARM II (SOC) |
| Questionnaire AdministrationAncillary studies | Other | ARM I (GAIN-S), ARM II (SOC) |
| Supportive CareAlso: Supportive Therapy, Symptom Management, Therapy, SupportiveReceive GA-based interventions | Other | ARM I (GAIN-S) |
| TelemedicineAlso: TelehealthReceive GA-based interventions via telemedicine | Other | ARM I (GAIN-S) |
Primary outcome
Rate of advance directive (AD) completion
Time frame: At start of treatment and 3 months after treatment initiation
Will be assessed using medical chart review. Chi-square test will be used to compare the proportions of AD completion between the two arms.
Number of documented conversations.
Time frame: At start of treatment and 3 months after treatment initiation
Will be assessed using medical chart review. T-test will be used to compare the mean number of documented conversations between the two arms.
Direct inpatient cost
Time frame: At 3 and 6-months after treatment initiation
Will log transformed and Z-score test will be used to compare the mean costs of the two arms. Chi-square test will be used to compare number of patients with short verse (vs.) long stay and Intensive Care Unit (ICU) admission between the two arms.
5 secondary outcomes
Decrease in treatment toxicity
Time frame: At 3 months after randomization
Proportion of patients with dose modifications
Time frame: Up to 6 months
Patient satisfaction using the "Was It Worth It" (WIWI)
Time frame: At 3 and/or 6-months after treatment initiation
Patient preferences and goals
Time frame: At baseline, 3 and/or 6 months after treatment initiation
Association of Community Cancer Centers (ACCC) Geriatric Oncology Gap Assessment Tool
Time frame: Baseline and at the end of study (36 months)
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 19 Oct 2026.
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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.
William Dale principal investigator
City of Hope Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Comprehensive Geriatric Assessment and Electronic Health Record Review in people with Hematopoietic and Lymphoid System Neoplasm and Malignant Solid Neoplasm, run by City of Hope Medical Center at 3 sites in United States.
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 6 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of advance directive (AD) completion (time frame: At start of treatment and 3 months after treatment initiation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2026.