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Registry of Older Patients With Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 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: October 10, 2014
Last verified: October 2014

June 3, 2010
October 10, 2014
September 2009
December 2016   (final data collection date for primary outcome measure)
  • 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 ]
  • Creation of a registry of older patients within the University of North Carolina's healthcare system [ Designated as safety issue: No ]
  • Completion of the Geriatric Assessment (GA) [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01137825 on ClinicalTrials.gov Archive Site
  • 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;
  • Response rate of GAs [ Designated as safety issue: No ]
  • Patient satisfaction [ Designated as safety issue: No ]
  • Collection of information that would lend support for future research [ Designated as safety issue: No ]
Not Provided
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Registry of Older Patients With Cancer
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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Oncology Patients or those with a presumed cancer diagnosis

  • 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
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
December 2018
December 2016   (final data collection date for primary outcome measure)

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
Both
65 Years and older
No
Contact: Shani Alston, MPH, CCRP (919) 843-1906 shani_alston@med.unc.edu
United States
 
NCT01137825
LCCC 0916, P30CA016086, CDR0000674085
No
UNC Lineberger Comprehensive Cancer Center
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Hyman Muss, MD UNC Lineberger Comprehensive Cancer Center
UNC Lineberger Comprehensive Cancer Center
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP