Clinical trial NCT02041416: Technology to Assess Vulnerable Older Adults With Cancer and Their Caregivers
Official title: Delivering the Geriatric Assessment Tool to Older Adults With Cancer Using Computer Survey Methodologies: Testing Feasibility, Reliability, and Validity of Research Electronic Data Capture (REDCap) and Support Screen (Touchscreen) Technologies
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cancer
Solid Tumor
Hematologic Malignancy
Keywords: Geriatric assessment
REDCap
touchscreen
age 65
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2014-01-22
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Using a prospective longitudinal study design, 100 patients will be recruited for this study from the outpatient medical oncology and hematology practice at City of Hope Medical Center.

Brief summary: The goal of this study is to determine the feasibility, reliability, and validity of administering the Geriatric Assessment Tool using these two different computer based survey platforms, REDCap and Support Screen. The development of a computer based Geriatric Assessment Tool has the potential to improve research and clinical practice by providing an efficient user friendly means to collect and analyze data for geriatric oncology patients.

Detailed description: Sixty percent of all cancer diagnoses and 70% of all cancer mortality occurs in patients age 65 and older. Patients older than age 65 years have an 11-fold increased cancer incidence and a 16-fold increase in cancer mortality in comparison to those younger than 65 years. The population at risk is growing rapidly: the number of adults age 65 years and older is expected to double in the next 30 years. In order to adequately care for this growing population of older adults, oncologists need an assessment tool that provides information regarding an older individual's "functional age" rather than just "chronological age." The Geriatric Assessment Tool developed by Hurria and colleagues has been found to help identify those older adults who are more vulnerable to complications from cancer treatment.

The Geriatric Assessment Tool takes into account well validated measures of functional status, co-morbid medical conditions, cognitive function, psychological state, nutritional status, social activity, and social support. Pilot data demonstrates the feasibility of this assessment which can be completed in less than 30 minutes; however, this assessment is completed by pencil and paper, and therefore requires an interviewer to deliver, score, and summarize the assessment results. The development of a computer based Geriatric Assessment Tool would have practical importance for both research and clinical practice. It could potentially allow more efficient data collection and analysis in the research setting. In turn it would potentially influence clinical decision making by medical oncologists given its ability to predict chemotherapy related toxicity among geriatric oncology patients across all tumor types.

Two electronic platforms have been developed for the Geriatric Assessment Tool:

1. Research Electronic Data Capture (REDCap) is a secure website designed by Vanderbilt University that is used by 48 countries, and 511 institutions around the world including research centers that comprise the Cancer and Aging Research Group. REDCap is a web-based application that allows researchers to build and manage online surveys and databases. It also provides a central web-based forum where data can be processed uniformly and efficiently. Administering the Geriatric Assessment Tool through REDCap would potentially improve data collection and analysis for elderly cancer patients across multiple research centers.
2. Support Screen is a program developed by researchers and information technology specialists at City of Hope utilizing touchscreen technology to deliver patient surveys. The touchscreen platform has been used in previous studies as a means of assessing the needs of cancer patients. Support Screen is an attractive technology given it is user friendly for patients and has the unique capability of transferring information from the touchscreen device directly into the City of Hope medical record system in a secure, HIPPA-compliant manner, thereby providing clinicians and researchers real time access to survey information. A pilot study looking at the feasibility of delivering the Geriatric Assessment to elderly cancer patients using Support Screen has been performed at City of Hope with promising results, but the reliability and validity of this modality have yet to be studied.

Eligibility criteria: Inclusion Criteria:

* Patients age ≥65 with any performance status
* Diagnosis of cancer (solid tumor or hematologic malignancy)
* Able to provide informed consent

Exclusion Criteria:

• Non-English speaking because some components of the geriatric assessment tool have not yet been validated in other languages.

Primary outcomes:
measure: Patient's ability to complete the assessment
timeFrame: 2 years
measure: Item correlation between different assessment platforms
timeFrame: 2 years
measure: Positive correlations between different measures of functional status
timeFrame: 2 years
Secondary outcomes:
measure: Questionnaire- percentage of patients who did not enter the study and the reason for declining participation
timeFrame: 2 years
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Arti Hurria, MD
role: PRINCIPAL_INVESTIGATOR
References: