City of Hope Medical Center
RecruitingDuarte, California, 91010, United States
Site contacts (2)
William DalePrincipal investigator
CLINICAL STUDY · NCT06022965
Telemedicine for Improvement of Care for Older Adults With Cancer in the Underserved Community, The GAIN-S Trial
RecruitingNot applicableInterventional
Sponsored by City of Hope Medical Center
- Condition
- Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm
- Study locations
- 3 reported sites
- Study updated
- 19 Oct 2026
- Source
- ClinicalTrials.gov
Overall study status is shown above. Individual hospitals may have a different recruitment status.
THE STUDY
About this study
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.
Full 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
Detailed description
PRIMARY OBJECTIVES:
I. 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:
I. 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.
I. 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:
I. 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.
PARTICIPATION
Who may participate
- Minimum age
- 65 Years
- Maximum age
- Not reported
- Sex eligibility
- All sexes
- Healthy volunteers
- Not accepted
Only the study team can confirm eligibility. The registry criteria below are not a medical recommendation.
Full inclusion and exclusion criteria
Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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).
* 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).
Exclusion Criteria:
* 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).
NEAR YOU
Study locations worldwide
3 sitesCheck the individual site’s status and contact the listed study team for current availability.
3 sites shown
City of Hope Antelope Valley
RecruitingLancaster, California, 93534, United States
Site contacts (2)
William DalePrincipal investigator
City of Hope Upland
RecruitingUpland, California, 91786, United States
Site contacts (2)
William DalePrincipal investigator
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WHAT IS BEING STUDIED
Treatments and study groups
Interventions
Best Practice
Receive SOC
Study groups: ARM I (GAIN-S), ARM II (SOC)
Other names: standard of care, standard therapy
Comprehensive Geriatric Assessment
Complete CARG-GA
Study groups: ARM I (GAIN-S), ARM II (SOC)
Electronic Health Record Review
Ancillary studies
Study groups: ARM I (GAIN-S), ARM II (SOC)
Questionnaire Administration
Ancillary studies
Study groups: ARM I (GAIN-S), ARM II (SOC)
Supportive Care
Receive GA-based interventions
Study groups: ARM I (GAIN-S)
Other names: Supportive Therapy, Symptom Management, Therapy, Supportive
Telemedicine
Receive GA-based interventions via telemedicine
Study groups: ARM I (GAIN-S)
Other names: Telehealth
Study groups
ARM I (GAIN-S)
Patients complete the CARG-GA at baseline and 3 months and receive GA-based interventions using telemedicine over 6 months.
Interventions: Other: Best Practice, Other: Comprehensive Geriatric Assessment, Other: Electronic Health Record Review, Other: Questionnaire Administration, Other: Supportive Care, Other: Telemedicine
ARM II (SOC)
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.
Patients complete the CARG-GA at baseline and 3 months and receive SOC over 6 months.
Interventions: Other: Best Practice, Other: Comprehensive Geriatric Assessment, Other: Electronic Health Record Review, Other: Questionnaire Administration
RESEARCH DETAILS
Study design
- Study type
- Interventional
- Phase
- Not applicable
- Primary purpose
- Supportive care
- Allocation
- Randomized
- Study model
- Parallel
- Masking
- None (open label)
- Enrolment
- 216 participants · Estimated
TIMELINE & MEASURES
Dates and outcomes
- Study started
- 10 Aug 2023 · Actual
- Primary completion
- 24 Jan 2027 · Estimated
- Study completion
- 24 Jan 2027 · Estimated
- First registered
- 5 Sep 2023 · Actual
- Last registry update
- 19 Oct 2026 · Actual
- Status last verified
- Oct 2026
Primary outcomes (3)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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.
Time frame: 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.
Time frame: 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.
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.
Time frame: Baseline and at the end of study (36 months)
STUDY TEAM
Sponsor and contacts
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- Other
- Collaborators
- National Cancer Institute (NCI)
- Organisation study ID
- 22343
Central study contacts
No central contact is currently reported. Check the site contacts or the official record.
Study officials
William DalePrincipal investigator · City of Hope Medical Center
Contacts are provided by the registry for study enquiries. Do not use these details for marketing or promotions.
FURTHER READING
Results, documents and references
No results are posted in this registry record
This does not mean the study has no findings. Results may not yet have been submitted or published here.
No study documents are listed in this record.