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

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

Study Overview

• Status: Completed
• Conditions: Self Geriatric Assessment Measure (SGAM)
• Intervention / Treatment: Other: Self Geriatric Assessment Measure (SGAM)

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.

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Levine Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; iPad administration of Self Geriatric Assessment Measure (SGAM)	Other: Self Geriatric Assessment Measure (SGAM); Self Geriatric Assessment Measure
Active Comparator: 2; Paper survey administration of Self Geriatric Assessment Measure (SGAM)	Other: Self Geriatric Assessment Measure (SGAM); Self Geriatric Assessment Measure

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Daniel Haggstrom, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2018
• Primary Completion (Actual): November 18, 2019
• Study Completion (Actual): November 18, 2019

Study Registration Dates

• First Submitted: January 11, 2018
• First Submitted That Met QC Criteria: January 26, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): August 10, 2022
• Last Update Submitted That Met QC Criteria: August 5, 2022
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: LCI-GER-NOS-TAB-001; 00023842 (Other Identifier: Advarra IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No