Telemedicine for Improvement of Care for Older Adults With Cancer in the Underserved Community, The GAIN-S Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorCity of Hope Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Best Practice
Other interventionReceive SOC
Comprehensive Geriatric Assessment
Other interventionComplete CARG-GA
Electronic Health Record Review
Other interventionAncillary studies
Questionnaire Administration
Other interventionAncillary studies
Supportive Care
Other interventionReceive GA-based interventions
Telemedicine
Other interventionReceive GA-based interventions via telemedicine
Treatment groups
216 Participants
are divided into 2 treatment groupsGroup A: ARM I (GAIN-S)Experimental treatment 6 interventions
Group B: ARM II (SOC)Active comparator 4 interventions
Trial outcomes
Primary outcomes
1
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 initiation2
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 initiation3
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 initiationSecondary outcomes
1
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 randomization2
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 months3
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.
Time frame
At 3 and/or 6-months after treatment initiation4
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 initiationSponsors and contacts
Click on the lead sponsor to view all of their trials.
City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov