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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01137825
Other study ID # LCCC 0916
Secondary ID P30CA016086CDR00
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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