Computer-Based Comprehensive Geriatric Assessment in Oncology for Individuals 70 or Older With Gastrointestinal Malignancies

Sponsor
Dana-Farber Cancer Institute (Other)
Overall Status
Completed
CT.gov ID
NCT00973440
Collaborator
American Society of Clinical Oncology (Other)
59
1
55
1.1

Study Details

Study Description

Brief Summary

Older individuals account for one-third of new cancer cases and cancer-related deaths in the United States. Older individuals are more susceptible to having a decrease in physical and mental function following chemotherapy treatment. Geriatric assessment may provide a way to identify those older individuals at greatest risk of functional decline before treatment starts and during the period of treatment. Geriatric assessment includes a set of screening questions and tests designed to determine the physical and mental status of the individual at a point in time. Geriatric assessment also includes review of medications and other medical conditions the individual may have that may affect function. The investigators are conducting this study to determine if older individuals are able to complete the geriatric assessment using a computer format and how that corresponds to their treating physician's assessment of their functional status before and after starting a new chemotherapy treatment for colon, rectal, breast or lung cancer. The investigators will also evaluate the usefulness of a computerized form of geriatric assessment.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    • Participants will complete the geriatric assessment on the computer either at their home via the web (if they have internet access) or in the clinic at their next visit prior to seeing the doctor.

    • All individuals will have a unique way to sign on to the computer program that protects the information so that only the participant and the research team will be able to view it. Individuals who require assistance to answer the questions will have help provided by a research assistant.

    • We will ask participants to complete the geriatric assessment a second time at 4 months after they have enrolled on the study or 1 month after completing their chemotherapy treatment, whichever occurs first.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    59 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Computer-Based Comprehensive Geriatric Assessment in Oncology for Individuals 70 or Older With Colorectal, Breast or Lung Cancer
    Study Start Date :
    Mar 1, 2009
    Actual Primary Completion Date :
    Jul 1, 2011
    Actual Study Completion Date :
    Oct 1, 2013

    Outcome Measures

    Primary Outcome Measures

    1. To determine the feasibility and added clinical utility of a self-administered computer-based version of an abbreviated comprehensive geriatric assessment tool. [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    70 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Ability to understand and the willingness to sign a written informed consent document

    • Patients with colorectal, breast or lung cancer at any stage who are under consideration for initiation of or change in cytotoxic chemotherapy regimen. Patients must start chemotherapy within 4 weeks of enrollment. Chemotherapy regimens may include traditional cytotoxic therapy, oral biological agent, or combination of a biologic therapy and cytotoxic chemotherapy.

    • Patients age 70 or older at enrollment

    • Patients must be able to read English and able to complete the web-based computer questionnaire

    Exclusion Criteria:
    • Patients with a physical limitation preventing computer use (visual impairment, inability to use computer mouse or touch screen).

    • Patients who are hospitalized or enrolled in hospice

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dana-Farber Cancer Institute Boston Massachusetts United States 02115

    Sponsors and Collaborators

    • Dana-Farber Cancer Institute
    • American Society of Clinical Oncology

    Investigators

    • Principal Investigator: Nadine J McCleary, MD, MPH, Dana-Farber Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nadine A. Jackson, MD, MPH, Principal Investigator, Dana-Farber Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT00973440
    Other Study ID Numbers:
    • 09-035
    First Posted:
    Sep 9, 2009
    Last Update Posted:
    Oct 22, 2013
    Last Verified:
    Oct 1, 2013
    Keywords provided by Nadine A. Jackson, MD, MPH, Principal Investigator, Dana-Farber Cancer Institute
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 22, 2013