Registry of Older Patients With Cancer

Lymphoma Clinical Trial

Official title:

Carolina Senior: UNC Registry for Older Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01137825
• Other study ID #: LCCC 0916
• Secondary ID: P30CA016086CDR00
• Status: Recruiting
• Start date: September 2009
• Est. completion date: December 2030

Study information

• Verified date: June 2023
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: Kirsten A Nyrop, PhD
• Phone: (919) 962-5139
• Email: knyrop[@]med.unc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

RATIONALE: Gathering information about older patients with cancer may help the study of cancer in the future.

PURPOSE: This research study is gathering information from older patients with cancer into a registry.

Description:

OBJECTIVES:

Primary

• To create a registry (to be called "Carolina Senior") of older patients with an appointment at North Carolina Cancer Hospital.

• To have these patients complete a Geriatric Assessment (GA).

Secondary

• To measure the response rates of GAs of Carolina Senior patients and their satisfaction with a GA by measuring the percentage of patients contacted who consent to complete the GA; the percentage of patients able to complete the self-administered portion of the GA without assistance; the length of time necessary to complete the GA; the variance and number of missing items; the percentage of GAs that contain all 3 of the following items: Timed Up and Go Assessment, Blessed Orientation-Memory-Concentration Test, and healthcare professional-rated Karnofsky performance status; and patient satisfaction with the questionnaire by identifying items that are distressing or too difficult to comprehend.

• To gather information, including patterns of patient care, that would lend support for future research in the 'Carolina Senior' population who receive a confirmed diagnosis of cancer (except for nonmelanoma skin cancer, cervical carcinoma in situ without evidence of disease, or prostatic intraepithelial neoplasia without evidence of prostate cancer).

OUTLINE: Patients complete a geriatric assessment, a multi-dimensional inter-disciplinary patient evaluation that includes an evaluation of a patient's functional status (ability to live independently at home and in the community), co-morbid medical conditions, cognition, psychological status, social functioning and support, medication review, and nutritional status. Patients' medical records are also reviewed. Patients' health status at 1 year is incorporated into the registry.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 2030
• Est. primary completion date: July 1, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Patients must have an appointment at the North Carolina Cancer Hospital and agree to complete the Geriatric Assessment NOTE: Not all patients included in the registry will ultimately be diagnosed with cancer. Patients who complete a GA and are not diagnosed with cancer will remain in the database, but will be categorized into a separate group and will not have their medical records accessed.

PATIENT CHARACTERISTICS:

• Able to read and speak English

PRIOR CONCURRENT THERAPY:

• Not specified

Related Conditions & MeSH terms

• Chronic Myeloproliferative Disorders
• Cognitive/Functional Effects
• Leukemia
• Lymphoma
• Lymphoproliferative Disorder
• Lymphoproliferative Disorders
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Myelodysplastic-Myeloproliferative Diseases
• Myelodysplastic/Myeloproliferative Neoplasms
• Myeloproliferative Disorders
• Neoplasms
• Neoplasms, Plasma Cell
• Plasmacytoma
• Preleukemia
• Syndrome
• Unspecified Adult Solid Tumor, Protocol Specific

Locations

Country	Name	City	State
United States	Seby B. Jones Cancer Center	Boone	North Carolina
United States	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina
United States	East Carolina University	Greenville	North Carolina
United States	Pardee Cancer Center	Hendersonville	North Carolina
United States	Carteret Health Care Cancer Center	Morehead City	North Carolina
United States	Carolina East Radiology	New Bern	North Carolina
United States	Rex Healthcare	Raleigh	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Creation of a registry of older patients within the University of North Carolina's healthcare system		4 years
Primary	Completion of the Geriatric Assessment (GA)		Upon subject's first visit to the clinic
Secondary	Information that would lend support for future research	Including patterns of patient care, that would lend support for future research in the 'Carolina Senior' population who receive a confirmed diagnosis of cancer with the exception of: Non-melanoma skin cancer; Cervical carcinoma in situ without evidence of disease; Prostatic intraepithelial neoplasia without evidence of prostate cancer	3 years
Secondary	Response rates of Geriatric Assessments of Carolina Senior patients and their satisfaction with the GA	Done by measuring: Percentage of patients contacted who consent to complete the GA; The percentage of patients able to complete the self-administered portion of the geriatric assessment without assistance; The length of time necessary to complete the geriatric assessment; The variance and number of missing items; The percentage of geriatric assessments that contain all three of the following items: Timed Up and Go Assessment, Blessed Orientation-Memory-Concentration Test, and healthcare professional-rated Karnofsky performance status;	2 years

External Links

•   web address for Lineberger Comprehensive Cancer Center, UNC
•   web address for the National Cancer Institute (NCI)