ClinicalTrials.gov record NCT01137825
Registry of Older Patients With Cancer
Carolina Senior: UNC Registry for Older Cancer Patients
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This study is creating a registry called Carolina Senior that gathers information from older people who have or are suspected of having cancer. Participants complete a geriatric assessment and researchers review medical records. Health status at about one year is also recorded.
What it is studying. The study is building a registry of older oncology patients and collecting standardized geriatric assessment (GA) results plus medical-record information. It is also measuring how patients respond to and complete the GA (for example, consent rates, ability to complete the self‑report portion, time needed, missing items, and satisfaction). The collected information is intended to describe patterns of care and support future research in this population.
What the researchers hope to learn. Scientific goals are to create the Carolina Senior registry; to collect and evaluate geriatric assessment data from older oncology patients; to measure response rates and patient satisfaction with the assessment; and to gather care-pattern information that can support future research in this population.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion 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
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Show the detailed description from the registry
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.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
You would complete a Geriatric Assessment (GA): a structured set of questions and brief tests about daily function, other medical conditions, thinking and memory, mood, social support, medications, and nutrition. Study staff will review your medical record and record your health status about 1 year later for the registry. People who complete the GA but are not later diagnosed with cancer will remain in the database in a separate group, and their medical records will not be accessed. The registry record does not list any invasive procedures (for example, bone‑marrow biopsy or spinal tap) or specify routine sample collection.
How the study is structured. This is an observational, prospective registry (case-only). Participants complete a multi-domain geriatric assessment once (covering function, medical conditions, thinking/memory, mood, social support, medications, and nutrition). Study staff review participants' medical records. Health status about one year after entry is recorded and entered into the registry.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
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Important dates
- Study start
- September 2009
- Primary completion
- Jul 1, 2030 (estimated)
- Study completion
- December 2030 (estimated)
- Target enrollment
- 3000 participants (estimated)
- Last updated on registry
- Jun 29, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Collaborators
- National Cancer Institute (NCI)
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Kirsten A Nyrop, PhD 📞 (919) 962-5139 ✉ knyrop@med.unc.edu
Participating sites (7)
- Seby B. Jones Cancer CenterRecruiting
Boone, North Carolina, 28607 · United States
- Marjorie Hrozencik, RN, BSN, OCN, CCRP · mhrozencik@apprhs.org
- Anna Sobol, MD
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillRecruiting
Chapel Hill, North Carolina, 27599-7295 · United States
- Amy L Garrett, MA, CCRC · 919-966-0695 · amy_garrett@med.unc.edu
- Hyman B. Muss, MD
- East Carolina UniversityRecruiting
Greenville, North Carolina, 27834 · United States
- Tiffanie Moore, MPH · MOORETI15@ecu.edu
- Rachel Raab, MD
- Pardee Cancer CenterRecruiting
Hendersonville, North Carolina, 28739 · United States
- Lynn Jones · lyn.jones@unchealth.unc.edu
- James Radford, MD
- Carteret Health Care Cancer CenterRecruiting
Morehead City, North Carolina, 28557 · United States
- Joanna Pittman · jlpittman@ccgh.org
- James Loynes, MD
- Carolina East RadiologyRecruiting
New Bern, North Carolina, 28560 · United States
- Lynn Jones, BSN, RN, OCN · ljones2@carolinaeasthealth.com
- Seth Miller, MD
- Rex HealthcareRecruiting
Raleigh, North Carolina, 27607 · United States
- Nancy Burns, RN · Nancy.Burns2@unchealth.unc.edu
- Oludamilola Olajide, MD
Terms used on this page · explanations by MedicalUpdates.ai
- registry
- An organised collection of information about people with a particular condition, gathered over time for research. Joining a registry usually means sharing medical information, not receiving a treatment.
- Karnofsky performance status
- A scale from 100 (no complaints) down to 0 that describes how well a person can carry out daily activities. Studies often require a minimum score.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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