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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00973440
Recruitment Status : Completed
First Posted : September 9, 2009
Last Update Posted : October 22, 2013
Sponsor:
Collaborator:
American Society of Clinical Oncology
Information provided by (Responsible Party):
Nadine A. Jackson, MD, MPH, Dana-Farber Cancer Institute

Tracking Information
First Submitted Date September 8, 2009
First Posted Date September 9, 2009
Last Update Posted Date October 22, 2013
Study Start Date March 2009
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 8, 2009)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Computer-Based Comprehensive Geriatric Assessment in Oncology for Individuals 70 or Older With Gastrointestinal Malignancies
Official Title Computer-Based Comprehensive Geriatric Assessment in Oncology for Individuals 70 or Older With Colorectal, Breast or Lung Cancer
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.
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Rectal Cancer
  • Breast Cancer
  • Lung Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 8, 2009)
59
Original Estimated Enrollment Same as current
Actual Study Completion Date October 2013
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 70 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00973440
Other Study ID Numbers 09-035
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Nadine A. Jackson, MD, MPH, Dana-Farber Cancer Institute
Study Sponsor Dana-Farber Cancer Institute
Collaborators American Society of Clinical Oncology
Investigators
Principal Investigator: Nadine J McCleary, MD, MPH Dana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date October 2013