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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03951090
Other study ID # LCCC 1538
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 25, 2016
Est. completion date April 24, 2018

Study information

Verified date May 2019
Source UNC Lineberger Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 148
Est. completion date April 24, 2018
Est. primary completion date April 24, 2018
Accepts healthy volunteers No
Gender All
Age group 70 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Results of the brief geriatric assessment
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 assessments
Providers will not receive results of the brief geriatric assessment. Participants will receive standard of care treatment

Locations

Country Name City State
United States UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina

Sponsors (1)

Lead Sponsor Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Referral rate for GA-identified deficits in intervention and control groups Number of participants with at least one referral for a GA-idenfied deficit 2 years
Secondary Referral to Physical and Occupational therapy Number of times physical and occupation therapy referral was given in Intervention and Control group 2 years
Secondary Referral to Geriatic Consultation Number of times a Geriatric Consultation referral was given in Intervention and Control group 2 years
Secondary Referral to Clinical Pharmacist Number of times Clinical Pharmacist referral was given in Intervention and Control group 2 years
Secondary Referral to Nutritionist Number of times Nutritionist referral was given in Intervention and Control group 2 years
Secondary Referral to psyhcosocial support team Number of times psychosocial support referral was given in Intervention and Control group 2 years
Secondary 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" 2 years
Secondary Physician Reported Satisfaction Number of times physician indicate "yes" report was helpful when asked "Is this report useful" 2 years
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