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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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

Other trials in United States

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:

  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.
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 groups in NCT02041416
Study groupRoleWhat they receive
Group 1REDCap and paper pencil
Group 2REDCap twice
Group 3Support Screen and paper pencil
Group 4Support Screen twice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. 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

  3. Positive correlations between different measures of functional status

    Internal consistency using Cronbach's alpha and Pearson's correlation.

    Measured: 2 years

Secondary outcomes (1)
  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.

  1. First posted22 Jan 2014 (estimated)
  2. Study start15 May 2013
  3. Primary completion6 Jan 2027 (estimated)
  4. Study completion6 Jan 2027 (estimated)

Resources

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)
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

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.

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