CancerNCT02041416
Technology to Assess Vulnerable Older Adults With Cancer and Their Caregivers
An observational study of Cancer and Solid Tumor, run by City of Hope Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cancer, Solid Tumor, Hematologic Malignancy
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2013to 6 Jan 2027
- Phase
- Observational
- 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
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.
Who may be able to join
- Patients age ≥65 with any performance status
- Diagnosis of cancer (solid tumor or hematologic malignancy)
- Able to provide informed consent
Who cannot join
- Non-English speaking because some components of the geriatric assessment tool have not yet been validated in other languages.
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
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
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.
Read the 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:
- 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.
- 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.
- Conditions
- Cancer, Solid Tumor, Hematologic Malignancy
- Keywords
- Geriatric assessment, REDCap, touchscreen, age 65
- Medical subject headings
- Neoplasms, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | REDCap and paper pencil | |
| Group 2 | REDCap twice | |
| Group 3 | Support Screen and paper pencil | |
| Group 4 | Support Screen twice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's ability to complete the assessment
Measured by responses to questionnaire. To be determined by the patient's ability to complete the assessment without assistance, the length of time it takes to complete the assessment, the mean number of missing items and patient satisfaction.
Measured: 2 years
Item correlation between different assessment platforms
Measured by responses to questionnaire. Test for item correlations greater than 0.7 versus a null hypothesis of correlation.
Measured: 2 years
Positive correlations between different measures of functional status
Internal consistency using Cronbach's alpha and Pearson's correlation.
Measured: 2 years
Secondary outcomes (1)
Questionnaire- percentage of patients who did not enter the study and the reason for declining participation
Determine if there are different demographic characteristics among those who decline versus participate. Patients who decline participation in the study will be asked for permission to capture the following demographic information: 1) age, 2) gender, 3) race, 4) ethnicity, and 5) reason for declining enrollment.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study start15 May 2013
- Primary completion6 Jan 2027 (estimated)
- Study completion6 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Arti Hurria, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041416
- Sponsor's protocol ID
- 13103
- Other IDs
- R21AG041489
- Status last verified
- Apr 2026
- First submitted
- 3 Jan 2014
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02041416
- Acronym / sponsor ID
- 13103
- Conditions
- Cancer, Solid Tumor, Hematologic Malignancy
- Keywords
- Geriatric assessment, REDCap, touchscreen, age 65
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 15 May 2013 (actual)
- Primary completion
- 6 Jan 2027 (estimated)
- Study completion
- 6 Jan 2027 (estimated)
- First posted
- 22 Jan 2014 (estimated)
- 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.
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:
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –REDCap and paper pencil |
| Group 2 | – | –REDCap twice |
| Group 3 | – | –Support Screen and paper pencil |
| Group 4 | – | –Support Screen twice |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (3 listed)
- Patients age ≥65 with any performance status
- Diagnosis of cancer (solid tumor or hematologic malignancy)
- Able to provide informed consent
Key exclusion criteria (1 listed)
- Non-English speaking because some components of the geriatric assessment tool have not yet been validated in other languages.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient's ability to complete the assessment
Time frame: 2 years
Measured by responses to questionnaire. To be determined by the patient's ability to complete the assessment without assistance, the length of time it takes to complete the assessment, the mean number of missing items and patient satisfaction.
Item correlation between different assessment platforms
Time frame: 2 years
Measured by responses to questionnaire. Test for item correlations greater than 0.7 versus a null hypothesis of correlation.
Positive correlations between different measures of functional status
Time frame: 2 years
Internal consistency using Cronbach's alpha and Pearson's correlation.
1 secondary outcome
Questionnaire- percentage of patients who did not enter the study and the reason for declining participation
Time frame: 2 years
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 20 Apr 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. This study is not recruiting at the moment.
Arti Hurria, MD principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Solid Tumor, run by City of Hope Medical Center at 1 site 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 3 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: under way, not looking for participants, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's ability to complete the assessment (time frame: 2 years). 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 20 Apr 2026.