Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2026-02-25 @ 12:57 AM
Study NCT ID:
NCT03419468
Status:
COMPLETED
Last Update Posted:
2022-08-10
First Post:
2018-01-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LCI-GER-NOS-TAB-001: Tablet for Geriatric Assessment
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
LCI-GER-NOS-TAB-001: Pilot Study of a Tablet to Administer the Cancer-Specific Geriatric Assessment (CSGA) in Geriatric Patients With Cancer
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Self Geriatric Assessment Measure \[SGAM\] is based on a standard diagnostic tool used to evaluate geriatric cancer patients in order to determine the appropriateness of cancer directed therapy at LCI. This questionnaire has sections that matches portions of a self-administered geriatric assessment in patients aged 70 or older with malignancy. The prolonged duration of time needed to complete the assessment makes its performance less feasible in standard practice settings.
In previously published studies the Cancer Specific Geriatric Assessment (CSGA) has been provided both via written questionnaire and by personal computer in subjects 70 years of age or older. With improvements in technology, the goal is to evaluate the feasibility of administering the SGAM via an iPad tablet and compare results to both gold standard paper format and prior desktop computer data.
This study proposes the use of an iPad tablet to administer the SGAM may help:
Improve the completion rate of the SGAM assessment Reduction in the time of completion Improvement in the accuracy of reporting
In previously published studies the Cancer Specific Geriatric Assessment (CSGA) has been provided both via written questionnaire and by personal computer in subjects 70 years of age or older. With improvements in technology, the goal is to evaluate the feasibility of administering the SGAM via an iPad tablet and compare results to both gold standard paper format and prior desktop computer data.
This study proposes the use of an iPad tablet to administer the SGAM may help:
Improve the completion rate of the SGAM assessment Reduction in the time of completion Improvement in the accuracy of reporting
Detailed Description:
Primary Objective
Assess and compare the proportions of subjects completing, defined as recording responses for at least 70% of actionable questions of the Self Geriatric Assessment Measure (SGAM) in subjects aged 70 years or older with malignancy using an iPad tablet versus written questionnaire.
Secondary Objectives
To assess and compare the proportions of subjects completing the SGAM without assistance using an iPad tablet versus written questionnaire.
To evaluate and compare the total times of interaction with the SGAM using an iPad tablet versus written questionnaire in both all evaluable subjects and the subset of evaluable subjects completing the SGAM.
To evaluate and compare the distributions of percentages of recorded responses on actionable questions (from 0% to 100%) on the SGAM using an iPad tablet versus written questionnaire in both all evaluable subjects and the subset of evaluable subjects completing the SGAM.
To describe the rate of technical issues experienced by iPad survey users.
To assess and compare the completion rates and times to completion of the gold standard written format.
Assess and compare the proportions of subjects completing, defined as recording responses for at least 70% of actionable questions of the Self Geriatric Assessment Measure (SGAM) in subjects aged 70 years or older with malignancy using an iPad tablet versus written questionnaire.
Secondary Objectives
To assess and compare the proportions of subjects completing the SGAM without assistance using an iPad tablet versus written questionnaire.
To evaluate and compare the total times of interaction with the SGAM using an iPad tablet versus written questionnaire in both all evaluable subjects and the subset of evaluable subjects completing the SGAM.
To evaluate and compare the distributions of percentages of recorded responses on actionable questions (from 0% to 100%) on the SGAM using an iPad tablet versus written questionnaire in both all evaluable subjects and the subset of evaluable subjects completing the SGAM.
To describe the rate of technical issues experienced by iPad survey users.
To assess and compare the completion rates and times to completion of the gold standard written format.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 00023842 | OTHER | Advarra IRB | View |