Registry of Older Patients With Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by UNC Lineberger Comprehensive Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01137825
First received: June 3, 2010
Last updated: June 17, 2014
Last verified: June 2014
  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

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Myelodysplastic Syndromes Leukemia, Myeloid Chronic Myeloid Leukemia Multiple Myeloma Lymphosarcoma Mantle Cell Lymphoma B-cell Lymphomas Burkitt Lymphoma Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma Acute Myelocytic Leukemia Acute Non Lymphoblastic Leukemia Follicular Lymphoma Lymphoma, Large-cell Acute Myeloid Leukemia, Adult Lymphoma, Small Cleaved-cell, Diffuse Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic Hodgkin Lymphoma Lymphoma, Large-cell, Immunoblastic Plasmablastic Lymphoma Mycosis Fungoides Sezary Syndrome Cutaneous T-cell Lymphoma Leukemia, T-cell, Chronic Myelofibrosis Waldenstrom Macroglobulinemia Anaplastic Large Cell Lymphoma Chronic Myelomonocytic Leukemia Hairy Cell Leukemia Lymphomatoid Granulomatosis Angioimmunoblastic T-cell Lymphoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Hypereosinophilic Syndrome Polycythemia Vera Chronic Myeloproliferative Disorders Essential Thrombocythemia Myelodysplastic/myeloproliferative Disease Anaplastic Plasmacytoma Large Granular Lymphocyte Leukemia AL Amyloidosis Chronic Neutrophilic Leukemia Systemic Mastocytosis
U.S. FDA Resources

Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 2018
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Oncology Patients or those with a presumed cancer diagnosis

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01137825

Contacts
Contact: Donna Rowe, RN (919) 966-7359 donna_rowe@med.unc.edu
Contact: Diane Winans (919) 843-2742 diane_winans@med.unc.edu

Locations
United States, North Carolina
Randolph Cancer Center Recruiting
Asheboro, North Carolina, United States, 27205
Principal Investigator: DeQuincy A. Lewis, MD         
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 Recruiting
Greenville, North Carolina, United States, 27834
Principal Investigator: Rachel Raab, MD         
Comprehensive Cancer Center at Pardee Recruiting
Hendersonville, North Carolina, United States, 28791
Principal Investigator: James Radford, MD         
Carteret General Hospital Recruiting
Morehead City, North Carolina, United States, 28557
Principal Investigator: James Loynes, 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: Xiang (Sean) Wang, MD         
Marion L. Shepard Cancer Center Recruiting
Washington, North Carolina, United States, 27889
Principal Investigator: John Inzerillo, MD         
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
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: June 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
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
stage II adult T-cell leukemia/lymphoma

Additional relevant MeSH terms:
Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Preleukemia
Lymphoma
Leukemia
Disease
Syndrome
Plasmacytoma
Myeloproliferative Disorders
Lymphoproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Precancerous Conditions
Lymphatic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014