Geriatric Assessment Reporting in Real Time (GARRT) in Non-electively Hospitalized Older Cancer Patients

NCT03951090 | Completed DMC

• 1 other identifier: LCCC 1538
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oncology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Referral to Physical and Occupational therapy

  2 years

• Referral to Geriatic Consultation

  2 years

• Referral to Clinical Pharmacist

  2 years

• Referral to Nutritionist

  2 years

• Referral to psyhcosocial support team

  2 years

Study Arms (2)

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

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

Other: No results of brief geriatric assessments

Interventions

Results of the brief geriatric assessment OTHER

Providers will receive results of the brief geriatric assessment with recommendations for address deficits identified through the results of the brief geriatric assessment

GARRT Arm

No results of brief geriatric assessments OTHER

Providers will not receive results of the brief geriatric assessment. Participants will receive standard of care treatment

Control Arm

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Trevor Jolly, MBBS

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: May 15, 2019
• Study Start: April 25, 2016
• Primary Completion: April 24, 2018
• Study Completion: April 24, 2018
• Last Updated: May 15, 2019

Record last verified: 2019-05

Locations

US (1)