OncologyNCT03951090
Geriatric Assessment Reporting in Real Time (GARRT) in Non-electively Hospitalized Older Cancer Patients
A study testing Results of the brief geriatric assessment and No results of brief geriatric assessments in people with Oncology, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
This study prospectively evaluates the impact of geriatric assessment reporting in real-time (GARRT) on key hospital based outcomes in a cohort of non-electively hospitalized older (> 70 years) adults with cancer. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Oncology
- What is being tested?
- Results of the brief geriatric assessment and No results of brief geriatric assessments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2016to 24 Apr 2018
- 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
- Age 70 years or older.
- English speaking.
- Admitted to UNC Hospitals non-electively within 72 hours.
- Biopsy proven solid tumor or myeloma or lymphoma.
- Newly diagnosed cancer patients for whom active cancer directed therapy is planned within the next six months or patients on active cancer directed therapy either currently or within the previous 6 months.
- Signed written IRB-approved informed consent.
Who cannot join
- Patients meeting any of the following exclusion criteria at baseline will be excluded from study participation. Patients with a life expectancy <6 weeks
- Patients who are <48 hours post-surgery.
- Patients who are admitted to an intensive care setting.
- Patients with acute myeloma lymphoma (AML) or other high grade hematologic malignancies.
- Patients undergoing bone marrow transplant or admitted to the bone marrow transplant unit.
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
About this study
This study prospectively evaluates the impact of geriatric assessment reporting in real-time (GARRT) on key hospital based outcomes in a cohort of non-electively hospitalized older (> 70 years) adults with cancer.
Read the detailed description
This study evaluates the impact of geriatric assessment reporting in real-time (GARRT) on key hospital based outcomes in non-electively hospitalized older (> 70 years) adults with cancer. Participants will be randomly assigned to the GARRT group, or the control group. All participants will fill out user friendly questionnaire called the geriatric assessment. The results of the geriatric assessment will be given to the physicians of participants in the GARRT group in real-time. The physicians of participants in the control group will not receive real time results.
This study will compare the referral rates of participants in each group to determine if providing real-time results of the geriatric assessment impact referral rates.
- Conditions
- Oncology
- Being tested
- Results of the brief geriatric assessment, No results of brief geriatric assessments
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Results of the brief geriatric assessmentOther
Providers will receive results of the brief geriatric assessment with recommendations for address deficits identified through the results of the brief geriatric assessment
No results of brief geriatric assessmentsOther
Providers will not receive results of the brief geriatric assessment. Participants will receive standard of care treatment
| Study group | Role | What they receive |
|---|---|---|
| GARRT Arm | Experimental | Participants in this arm complete an brief geriatric assessment, and the results of these assessments are given to providers with recommendations to address deficits identified by the geriatric assessment Receives: Other: Results of the brief geriatric assessment |
| Control Arm | Active comparator | Providers of participants of this group will not receive the results of the brief geriatric assessments. These participants will receive standard of care treatment Receives: Other: No results of brief geriatric assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Referral rate for GA-identified deficits in intervention and control groups
Number of participants with at least one referral for a GA-idenfied deficit
Measured: 2 years
Secondary outcomes (7)
Referral to Physical and Occupational therapy
Number of times physical and occupation therapy referral was given in Intervention and Control group
Measured: 2 years
Referral to Geriatic Consultation
Number of times a Geriatric Consultation referral was given in Intervention and Control group
Measured: 2 years
Referral to Clinical Pharmacist
Number of times Clinical Pharmacist referral was given in Intervention and Control group
Measured: 2 years
Referral to Nutritionist
Number of times Nutritionist referral was given in Intervention and Control group
Measured: 2 years
Referral to psyhcosocial support team
Number of times psychosocial support referral was given in Intervention and Control group
Measured: 2 years
Physician Reported New information
Number of times physicians answer "yes" to the questions "did report provide new information about patient deficits that would warrant a referral"
Measured: 2 years
Physician Reported Satisfaction
Number of times physician indicate "yes" report was helpful when asked "Is this report useful"
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start25 Apr 2016
- Primary completion24 Apr 2018
- Study completion24 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an un-blinded, 2-arm randomized control trial of a brief, user friendly GA report in real time which summarizes GA-identified deficits and includes recommendations for evidence informed multidisciplinary interventions to address these deficits.
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Trevor Jolly, MBBS, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03951090
- Sponsor's protocol ID
- LCCC 1538
- Status last verified
- May 2019
- First submitted
- 13 May 2019
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Geriatric Assessment Reporting in Real Time (GARRT) in Non-electively Hospitalized Older Cancer Patients
- ClinicalTrials.gov ID
- NCT03951090
- Acronym / sponsor ID
- LCCC 1538
- Conditions
- Oncology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 25 Apr 2016 (actual)
- Primary completion
- 24 Apr 2018 (actual)
- Study completion
- 24 Apr 2018 (actual)
- First posted
- 15 May 2019 (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.
This study prospectively evaluates the impact of geriatric assessment reporting in real-time (GARRT) on key hospital based outcomes in a cohort of non-electively hospitalized older (> 70 years) adults with cancer.
Detailed description
This study evaluates the impact of geriatric assessment reporting in real-time (GARRT) on key hospital based outcomes in non-electively hospitalized older (> 70 years) adults with cancer. Participants will be randomly assigned to the GARRT group, or the control group. All participants will fill out user friendly questionnaire called the geriatric assessment. The results of the geriatric assessment will be given to the physicians of participants in the GARRT group in real-time. The physicians of participants in the control group will not receive real time results.
This study will compare the referral rates of participants in each group to determine if providing real-time results of the geriatric assessment impact referral rates.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an un-blinded, 2-arm randomized control trial of a brief, user friendly GA report in real time which summarizes GA-identified deficits and includes recommendations for evidence informed multidisciplinary interventions to address these deficits.
| Arm | Type | Receives |
|---|---|---|
| GARRT Arm | Experimental | Other: Results of the brief geriatric assessmentParticipants in this arm complete an brief geriatric assessment, and the results of these assessments are given to providers with recommendations to address deficits identified by the geriatric assessment |
| Control Arm | Active comparator | Other: No results of brief geriatric assessmentsProviders of participants of this group will not receive the results of the brief geriatric assessments. These participants will receive standard of care treatment |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Age 70 years or older.
- English speaking.
- Admitted to UNC Hospitals non-electively within 72 hours.
- Biopsy proven solid tumor or myeloma or lymphoma.
- Newly diagnosed cancer patients for whom active cancer directed therapy is planned within the next six months or patients on active cancer directed therapy either currently or within the previous 6 months.
Key exclusion criteria (5 listed)
- Patients meeting any of the following exclusion criteria at baseline will be excluded from study participation. Patients with a life expectancy <6 weeks
- Patients who are <48 hours post-surgery.
- Patients who are admitted to an intensive care setting.
- Patients with acute myeloma lymphoma (AML) or other high grade hematologic malignancies.
- Patients undergoing bone marrow transplant or admitted to the bone marrow transplant unit.
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 |
|---|---|---|
| Results of the brief geriatric assessmentProviders will receive results of the brief geriatric assessment with recommendations for address deficits identified through the results of the brief geriatric assessment | Other | GARRT Arm |
| No results of brief geriatric assessmentsProviders will not receive results of the brief geriatric assessment. Participants will receive standard of care treatment | Other | Control Arm |
Primary outcome
Referral rate for GA-identified deficits in intervention and control groups
Time frame: 2 years
Number of participants with at least one referral for a GA-idenfied deficit
7 secondary outcomes
Referral to Physical and Occupational therapy
Time frame: 2 years
Referral to Geriatic Consultation
Time frame: 2 years
Referral to Clinical Pharmacist
Time frame: 2 years
Referral to Nutritionist
Time frame: 2 years
Referral to psyhcosocial support team
Time frame: 2 years
Physician Reported New information
Time frame: 2 years
Physician Reported Satisfaction
Time frame: 2 years
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 15 May 2019.
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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.
Trevor Jolly, MBBS principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Results of the brief geriatric assessment and No results of brief geriatric assessments in people with Oncology, run by UNC Lineberger Comprehensive Cancer Center 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 5 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 15 May 2019. 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?
Referral rate for GA-identified deficits in intervention and control groups (time frame: 2 years). 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 15 May 2019.