Registry of Older Patients With Cancer

NCT ID: NCT01137825

Last Updated: 2025-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2030-12-31

Brief Summary

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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

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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

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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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hyman Muss, MD

Role: PRINCIPAL_INVESTIGATOR

UNC Lineberger Comprehensive Cancer Center

Locations

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Seby B. Jones Cancer Center

Boone, North Carolina, United States

Site Status RECRUITING

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, United States

Site Status RECRUITING

East Carolina University

Greenville, North Carolina, United States

Site Status RECRUITING

Pardee Cancer Center

Hendersonville, North Carolina, United States

Site Status RECRUITING

Carteret Health Care Cancer Center

Morehead City, North Carolina, United States

Site Status RECRUITING

Carolina East Radiology

New Bern, North Carolina, United States

Site Status RECRUITING

Rex Healthcare

Raleigh, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kirsten A Nyrop, PhD

Role: CONTACT

(919) 962-5139

Facility Contacts

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Marjorie Hrozencik, RN, BSN, OCN, CCRP

Role: primary

Amy L Garrett, MA, CCRC

Role: primary

919-966-0695

Tiffanie Moore, MPH

Role: primary

Lynn Jones

Role: primary

Joanna Pittman

Role: primary

Lynn Jones, BSN, RN, OCN

Role: primary

Nancy Burns, RN

Role: primary

References

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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.

Reference Type DERIVED
PMID: 30205939 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26175532 (View on PubMed)

Related Links

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http://unclineberger.org

web address for Lineberger Comprehensive Cancer Center, UNC

http://cancer.gov

web address for the National Cancer Institute (NCI)

Other Identifiers

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P30CA016086

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000674085

Identifier Type: OTHER

Identifier Source: secondary_id

LCCC 0916

Identifier Type: -

Identifier Source: org_study_id

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