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| ID | Type | Description | Link |
|---|---|---|---|
| 00023842 | Other Identifier | Advarra IRB |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | iPad administration of Self Geriatric Assessment Measure (SGAM) |
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| 2 | Active Comparator | Paper survey administration of Self Geriatric Assessment Measure (SGAM) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self Geriatric Assessment Measure (SGAM) | Other | Self Geriatric Assessment Measure |
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| Measure | Description | Time Frame |
|---|---|---|
| Survey completion rate | Assess and compare the proportions of subjects completing, defined as recording responses for at least 70% of actionable questions of the SGAM in subjects aged 70 years or older with malignancy using an iPad tablet versus written questionnaire. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of survey completion without assistance | To assess and compare the proportions of subjects completing the SGAM without assistance using an iPad tablet versus written questionnaire. | 12 months |
| Total time of interaction with iPad survey |
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Inclusion Criteria
Subjects must meet all of the following criteria:
Exclusion Criteria
Subjects must not meet any of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Haggstrom, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Levine Cancer Institute | Charlotte | North Carolina | 28203 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 12, 2018 | Aug 5, 2022 | ICF_000.pdf |
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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.
| 12 months |
| Percentage of recorded responses | 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. | 12 months |
| Rate of technical issues within iPad group | To describe the rate of technical issues experienced by iPad survey users. | 12 months |