Registry of Older Patients With Cancer

June 21, 2023 updated by: UNC Lineberger Comprehensive Cancer Center

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • North Carolina
      • Boone, North Carolina, United States, 28607
        • Recruiting
        • Seby B. Jones Cancer Center
        • Contact:
        • Principal Investigator:
          • Anna Sobol, MD
      • Chapel Hill, North Carolina, United States, 27599-7295
        • Recruiting
        • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
        • Contact:
        • Principal Investigator:
          • Hyman B. Muss, MD
      • Greenville, North Carolina, United States, 27834
        • Recruiting
        • East Carolina University
        • Contact:
        • Principal Investigator:
          • Rachel Raab, MD
      • Hendersonville, North Carolina, United States, 28739
      • Morehead City, North Carolina, United States, 28557
        • Recruiting
        • Carteret Health Care Cancer Center
        • Contact:
        • Principal Investigator:
          • James Loynes, MD
      • New Bern, North Carolina, United States, 28560
      • Raleigh, North Carolina, United States, 27607

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Oncology Patients or those with a presumed cancer diagnosis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Creation of a registry of older patients within the University of North Carolina's healthcare system
Time Frame: 4 years
4 years
Completion of the Geriatric Assessment (GA)
Time Frame: Upon subject's first visit to the clinic
Upon subject's first visit to the clinic

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Information that would lend support for future research
Time Frame: 3 years

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
3 years
Response rates of Geriatric Assessments of Carolina Senior patients and their satisfaction with the GA
Time Frame: 2 years

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;
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Hyman Muss, MD, UNC Lineberger Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Estimated)

July 1, 2030

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

June 3, 2010

First Submitted That Met QC Criteria

June 3, 2010

First Posted (Estimated)

June 4, 2010

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 21, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCCC 0916
  • P30CA016086 (U.S. NIH Grant/Contract)
  • CDR0000674085 (Other Identifier: PDQ number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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