Skip to content

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

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03419468
Enrollment
89
Registered
2018-02-05
Start date
2018-01-12
Completion date
2019-11-18
Last updated
2022-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Self Geriatric Assessment Measure (SGAM)

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

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.

Interventions

OTHERSelf Geriatric Assessment Measure (SGAM)

Self Geriatric Assessment Measure

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Survey completion rate12 monthsAssess 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.

Secondary

MeasureTime frameDescription
Rate of survey completion without assistance12 monthsTo assess and compare the proportions of subjects completing the SGAM without assistance using an iPad tablet versus written questionnaire.
Total time of interaction with iPad survey12 monthsTo 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.
Percentage of recorded responses12 monthsTo 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.
Rate of technical issues within iPad group12 monthsTo describe the rate of technical issues experienced by iPad survey users.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026