Self Geriatric Assessment Measure (SGAM)NCT03419468
LCI-GER-NOS-TAB-001: Tablet for Geriatric Assessment
A study testing Self Geriatric Assessment Measure (SGAM) in people with Self Geriatric Assessment Measure (SGAM), run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Self Geriatric Assessment Measure (SGAM)
- What is being tested?
- Self Geriatric Assessment Measure (SGAM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2018to 18 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Levine Cancer Institute
Charlotte, North Carolina, 28203
About this study
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
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.
Read more
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
Read the 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.
- Conditions
- Self Geriatric Assessment Measure (SGAM)
- Being tested
- Self Geriatric Assessment Measure (SGAM)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self Geriatric Assessment Measure (SGAM)Other
Self Geriatric Assessment Measure
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | iPad administration of Self Geriatric Assessment Measure (SGAM) Receives: Other: Self Geriatric Assessment Measure (SGAM) |
| 2 | Active comparator | Paper survey administration of Self Geriatric Assessment Measure (SGAM) Receives: Other: Self Geriatric Assessment Measure (SGAM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 12 months
Rate of technical issues within iPad group
To describe the rate of technical issues experienced by iPad survey users.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start12 Jan 2018
- Primary completion18 Nov 2019
- Study completion18 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self Geriatric Assessment Measure (SGAM)Studies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Haggstrom, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03419468
- Sponsor's protocol ID
- LCI-GER-NOS-TAB-001
- Other IDs
- 00023842
- Status last verified
- Feb 2021
- First submitted
- 11 Jan 2018
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03419468
- Acronym / sponsor ID
- LCI-GER-NOS-TAB-001
- Conditions
- Self Geriatric Assessment Measure (SGAM)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 12 Jan 2018 (actual)
- Primary completion
- 18 Nov 2019 (actual)
- Study completion
- 18 Nov 2019 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Self Geriatric Assessment Measure (SGAM)iPad administration of Self Geriatric Assessment Measure (SGAM) |
| 2 | Active comparator | Other: Self Geriatric Assessment Measure (SGAM)Paper survey administration of Self Geriatric Assessment Measure (SGAM) |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self Geriatric Assessment Measure (SGAM)Self Geriatric Assessment Measure | Other | 1, 2 |
Primary outcome
Survey completion rate
Time frame: 12 months
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.
4 secondary outcomes
Rate of survey completion without assistance
Time frame: 12 months
Total time of interaction with iPad survey
Time frame: 12 months
Percentage of recorded responses
Time frame: 12 months
Rate of technical issues within iPad group
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Haggstrom, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self Geriatric Assessment Measure (SGAM) in people with Self Geriatric Assessment Measure (SGAM), run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survey completion rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.