Chronic Myeloproliferative DisordersNCT01137825
Registry of Older Patients With Cancer
An observational study of Chronic Myeloproliferative Disorders and Cognitive/Functional Effects, run by UNC Lineberger Comprehensive Cancer Center at 7 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Myeloproliferative Disorders, Cognitive/Functional Effects, Leukemia
- How many people
- 3,000 participants
- Where
- 7 sitesUnited States
- Study dates
- Sep 2009to Dec 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Oncology Patients or those with a presumed cancer diagnosis
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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Seby B. Jones Cancer Center
Boone, North Carolina, 28607
Marjorie Hrozencik, RN, BSN, OCN, CCRP, mhrozencik@apprhs.org
Anna Sobol, MD
- Recruiting
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599-7295
Amy L Garrett, MA, CCRC, 919-966-0695, amy_garrett@med.unc.edu
Hyman B. Muss, MD
- Recruiting
East Carolina University
Greenville, North Carolina, 27834
Tiffanie Moore, MPH, MOORETI15@ecu.edu
Rachel Raab, MD
- Recruiting
Pardee Cancer Center
Hendersonville, North Carolina, 28739
Lynn Jones, lyn.jones@unchealth.unc.edu
James Radford, MD
- Recruiting
Carteret Health Care Cancer Center
Morehead City, North Carolina, 28557
Joanna Pittman, jlpittman@ccgh.org
James Loynes, MD
- Recruiting
Carolina East Radiology
New Bern, North Carolina, 28560
Lynn Jones, BSN, RN, OCN, ljones2@carolinaeasthealth.com
Seth Miller, MD
- Recruiting
Rex Healthcare
Raleigh, North Carolina, 27607
Nancy Burns, RN, Nancy.Burns2@unchealth.unc.edu
Oludamilola Olajide, MD
About this study
Official title: Carolina Senior: UNC Registry for Older Cancer Patients
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.
Read the 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
- Chronic Myeloproliferative Disorders, Cognitive/Functional Effects, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm
- 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), atypical chronic myeloid leukemia, BCR-ABL negative, blastic phase chronic myelogenous leukemia, chronic myelomonocytic leukemia, chronic phase chronic myelogenous leukemia, mast cell leukemia, meningeal chronic myelogenous leukemia, progressive hairy cell leukemia, initial treatment, prolymphocytic leukemia, recurrent adult acute lymphoblastic leukemia
- Medical subject headings
- Myeloproliferative Disorders, Leukemia, Lymphoma, Lymphoproliferative Disorders, Multiple Myeloma, Neoplasms, Plasma Cell, Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Creation of a registry of older patients within the University of North Carolina's healthcare system
Measured: 4 years
Completion of the Geriatric Assessment (GA)
Measured: Upon subject's first visit to the clinic
Secondary outcomes (2)
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
Measured: 3 years
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;
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2010 (estimated)
- Study startSep 2009
- Primary completion1 Jul 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Myeloproliferative DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Hyman Muss, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01137825
- Sponsor's protocol ID
- LCCC 0916
- Other IDs
- P30CA016086, CDR0000674085
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2010
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 30205939Guerard 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.
PubMed 26175532