ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 20 for:    hurria

Technology to Assess Vulnerable Older Adults With Cancer and Their Caregivers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02041416
Recruitment Status : Active, not recruiting
First Posted : January 22, 2014
Last Update Posted : December 8, 2017
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
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.

Condition or disease
Cancer Solid Tumor Hematologic Malignancy

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.

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : May 2013
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Group/Cohort
Group 1
REDCap and paper pencil
Group 2
REDCap twice
Group 3
Support Screen and paper pencil
Group 4
Support Screen twice



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Positive correlations between different measures of functional status [ Time Frame: 2 years ]
    Internal consistency using Cronbach's alpha and Pearson's correlation.


Secondary Outcome Measures :
  1. Questionnaire- percentage of patients who did not enter the study and the reason for declining participation [ Time Frame: 2 years ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02041416


Locations
United States, California
City of Hope Medical Center
Duarte, California, United States, 91010
Sponsors and Collaborators
City of Hope Medical Center
National Institute on Aging (NIA)
Investigators
Principal Investigator: Arti Hurria, MD City of Hope Medical Center

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT02041416     History of Changes
Other Study ID Numbers: 13103
R21AG041489 ( U.S. NIH Grant/Contract )
First Posted: January 22, 2014    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017

Keywords provided by City of Hope Medical Center:
Geriatric assessment
REDCap
touchscreen
age 65