Registry of Older Patients With Cancer

Recruiting

• Conditions: Chronic Myeloproliferative Disorders; Cognitive/Functional Effects; Lymphoma; Lymphoproliferative Disorder; Myelodysplastic/Myeloproliferative Neoplasms; Leukemia; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT01137825
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-06-03
• Study First Submitted QC: 2010-06-03
• Study First Posted: 2010-06-04
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-24
• Last Update Posted: 2024-06-25
• Primary Completion: 2030-07-01
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Creation of a registry of older patients within the University of North Carolina's healthcare system	4 years
Completion of the Geriatric Assessment (GA)	Upon subject's first visit to the clinic

Secondary Outcome Measures

Name	Time	Method
Response rates of Geriatric Assessments of Carolina Senior patients and their satisfaction with the GA	2 years	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;
Information that would lend support for future research	3 years	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

Trial Locations

Locations (7)

East Carolina University; 🇺🇸 Greenville, North Carolina, United States

Rex Healthcare; 🇺🇸 Raleigh, North Carolina, United States

Seby B. Jones Cancer Center; 🇺🇸 Boone, 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

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States