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

This study has been completed.
Sponsor:
Collaborator:
American Society of Clinical Oncology
Information provided by (Responsible Party):
Nadine A. Jackson, MD, MPH, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00973440
First received: September 8, 2009
Last updated: October 21, 2013
Last verified: October 2013
  Purpose

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
Rectal Cancer
Breast Cancer
Lung Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To determine the feasibility and added clinical utility of a self-administered computer-based version of an abbreviated comprehensive geriatric assessment tool. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 59
Study Start Date: March 2009
Study Completion Date: October 2013
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants are identified by review of the clinic visit schedule at the Dana-Farber Cancer Institute, identifying individuals age 70 and older diagnosed with colon, rectal, breast or lung cancer

Criteria

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
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: NCT00973440

Locations
United States, Massachusetts
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
  More Information

No publications provided

Responsible Party: Nadine A. Jackson, MD, MPH, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00973440     History of Changes
Other Study ID Numbers: 09-035
Study First Received: September 8, 2009
Last Updated: October 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
geriatric assessment

Additional relevant MeSH terms:
Lung Neoplasms
Breast Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 30, 2014