Registry of Older Patients With Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Myeloproliferative Disorders, Cognitive/Functional Effects, Leukemia, Lymphoma. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Carolina Senior: UNC Registry for Older Cancer Patients
Overview
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.
Primary outcome measures
- Creation of a registry of older patients within the University of North Carolina's healthcare system [Time frame: 4 years]
- Completion of the Geriatric Assessment (GA) [Time frame: Upon subject's first visit to the clinic]
Secondary outcome measures (2)
- Information that would lend support for future research [Time frame: 3 years]
- Response rates of Geriatric Assessments of Carolina Senior patients and their satisfaction with the GA [Time frame: 2 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 7 centers
- Seby B. Jones Cancer Center — Boone
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill — Chapel Hill
- East Carolina University — Greenville
- Pardee Cancer Center — Hendersonville
- Carteret Health Care Cancer Center — Morehead City
- Carolina East Radiology — New Bern
- Rex Healthcare — Raleigh
Publications
- 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. PMID 30205939
- 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. PMID 26175532
Identifiers
NCT: NCT01137825 · LCCC 0916 · P30CA016086 · CDR0000674085