Telemedicine for Improvement of Care for Older Adults With Cancer in the Underserved Community, The GAIN-S Trial
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About
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 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.
Enrollment
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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).
Trial design
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Interventional model
Masking
216 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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