LCI-GER-NOS-TAB-001: Tablet for Geriatric Assessment

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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LCI-GER-NOS-TAB-001: Pilot Study of a Tablet to Administer the Cancer-Specific Geriatric Assessment (CSGA) in Geriatric Patients With Cancer

Conditions
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Self Geriatric Assessment Measure (SGAM)

Intervention / Treatment
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* Other: Self Geriatric Assessment Measure (SGAM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Subjects must meet all of the following criteria: At least 70 years of age Histologically or cytologically confirmed malignancy within the past 1 year Ability to read and understand English Willingness to complete either tablet or paper based assessment independently and without assistance from caregiver, if applicable Willingness and ability to understand and sign a written informed consent document Exclusion Criteria Subjects must not meet any of the following criteria: Any prior history of whole brain radiation therapy for known brain metastasis Known cerebrovascular event within the last 4 weeks from enrollment Known to be legally blind or has a history of severe hearing loss that could impair ability to complete questionnaire in the opinion of the investigator

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>iPad administration of Self Geriatric Assessment Measure (SGAM) | Other: Self Geriatric Assessment Measure (SGAM)<br>* Self Geriatric Assessment Measure<br>|
| Active Comparator: 2<br>Paper survey administration of Self Geriatric Assessment Measure (SGAM) | Other: Self Geriatric Assessment Measure (SGAM)<br>* Self Geriatric Assessment Measure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |