Carolina Senior: UNC Registry for Older Cancer Patients
Acronym
Not provided
Organization
UNC Lineberger Comprehensive Cancer CenterOTHER
Status Module
Record Verification Date
Jun 2026
Overall Recruitment Status or Expanded Access Status
Recruiting
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 2009
Primary Completion Date
Jul 1, 2030Estimated
Completion Date
Dec 2030Estimated
First Submitted Date
Jun 3, 2010
First Submission Date that Met QC Criteria
Jun 3, 2010
First Posted Date
Jun 4, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 24, 2026
Last Update Posted Date
Jun 29, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
UNC Lineberger Comprehensive Cancer CenterOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Conditions Module
Conditions
Chronic Myeloproliferative Disorders
Cognitive/Functional Effects
Leukemia
Lymphoma
Lymphoproliferative Disorder
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Unspecified Adult Solid Tumor, Protocol Specific
Keywords
cognitive/functional effects
unspecified adult solid tumor, protocol specific
accelerated phase chronic myelogenous leukemia
acute undifferentiated leukemia
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
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 Outcomes
Measure
Description
Time Frame
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
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
65 Years
Maximum Age
Not provided
Standard Ages
Older Adult
Study Population
Oncology Patients or those with a presumed cancer diagnosis
Pergolotti M, Langer MM, Deal AM, Muss HB, Nyrop K, Williams G. Mental status evaluation in older adults with cancer: Development of the Mental Health Index-13. J Geriatr Oncol. 2019 Mar;10(2):241-245. doi: 10.1016/j.jgo.2018.08.009. Epub 2018 Sep 8.
Guerard EJ, Deal AM, Williams GR, Jolly TA, Nyrop KA, Muss HB. Falls in Older Adults With Cancer: Evaluation by Oncology Providers. J Oncol Pract. 2015 Nov;11(6):470-4. doi: 10.1200/JOP.2014.003517. Epub 2015 Jul 14.
See Also Links
Label
URL
web address for Lineberger Comprehensive Cancer Center, UNC
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;