Registry of Older Patients With Cancer
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Phase |
|---|---|
|
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 |
Phase 1 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Carolina Senior: UNC Registry for Older Cancer Patients |
- Creation of a registry of older patients within the University of North Carolina's healthcare system [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- Completion of the Geriatric Assessment (GA) [ Time Frame: Upon subject's first visit to the clinic ] [ Designated as safety issue: No ]
- Information that would lend support for future research [ Time Frame: 3 years ] [ Designated as safety issue: No ]
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
- Response rates of Geriatric Assessments of Carolina Senior patients and their satisfaction with the GA [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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;
| Estimated Enrollment: | 150 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
Contacts and Locations| Contact: Donna Rowe, RN | (919) 966-7359 | donna_rowe@med.unc.edu |
| Contact: Diane Winans | (919) 843-2742 | diane_winans@med.unc.edu |
| United States, North Carolina | |
| Mission St. Joseph's | Recruiting |
| Asheville, North Carolina, United States, 28801 | |
| Principal Investigator: Michael Messino, MD | |
| Seby B. Jones Cancer Center | Recruiting |
| Boone, North Carolina, United States, 28607 | |
| Principal Investigator: Anna Sobol, MD | |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Recruiting |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| Contact 919-966-4432 | |
| East Carolina University | Not yet recruiting |
| Greenville, North Carolina, United States | |
| Principal Investigator: Rachel Raab, MD | |
| Comprehensive Cancer Center at Pardee | Not yet recruiting |
| Hendersonville, North Carolina, United States | |
| Principal Investigator: James Radford, MD | |
| New Bern Cancer Care, PA | Active, not recruiting |
| New Bern, North Carolina, United States, 28562 | |
| Rex Healthcare | Recruiting |
| Raleigh, North Carolina, United States, 27607 | |
| Principal Investigator: Oludamilola Olajide, MD | |
| Nash Heathcare | Recruiting |
| Rocky Mount, North Carolina, United States, 27804 | |
| Principal Investigator: Francisco Castillos, MD | |
| Marion L. Shepard Cancer Center | Recruiting |
| Washington, North Carolina, United States, 27889 | |
| Principal Investigator: John Inzerillo, MD | |
| Principal Investigator: | Hyman Muss, MD | UNC Lineberger Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | UNC Lineberger Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01137825 History of Changes |
| Other Study ID Numbers: | LCCC 0916, P30CA016086, CDR0000674085 |
| Study First Received: | June 3, 2010 |
| Last Updated: | April 23, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by UNC Lineberger Comprehensive Cancer Center:
|
essential thrombocythemia 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 recurrent adult acute myeloid leukemia recurrent adult T-cell leukemia/lymphoma refractory chronic lymphocytic leukemia refractory hairy cell leukemia relapsing chronic myelogenous leukemia secondary acute myeloid leukemia stage 0 chronic lymphocytic leukemia stage I adult T-cell leukemia/lymphoma stage I chronic lymphocytic leukemia |
Additional relevant MeSH terms:
|
Neoplasms Leukemia Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Myelodysplastic Syndromes Preleukemia Myeloproliferative Disorders Lymphoma, Large-Cell, Immunoblastic Myelodysplastic-Myeloproliferative Diseases |
Neoplasms by Histologic Type Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Bone Marrow Diseases Precancerous Conditions |
ClinicalTrials.gov processed this record on May 19, 2013