Rectal CancerNCT00973440
Computer-Based Comprehensive Geriatric Assessment in Oncology for Individuals 70 or Older With Gastrointestinal Malignancies
An observational study of Rectal Cancer and Breast Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Rectal Cancer, Breast Cancer, Lung Cancer
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Oct 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: Computer-Based Comprehensive Geriatric Assessment in Oncology for Individuals 70 or Older With Colorectal, Breast or Lung Cancer
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.
Read the 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.
- Conditions
- Rectal Cancer, Breast Cancer, Lung Cancer
- Keywords
- geriatric assessment
- Medical subject headings
- Rectal Neoplasms, Breast Neoplasms, Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the feasibility and added clinical utility of a self-administered computer-based version of an abbreviated comprehensive geriatric assessment tool.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startMar 2009
- Primary completionJul 2011
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- American Society of Clinical Oncology
- Responsible party
- Principal investigator, Nadine A. Jackson, MD, MPH, Dana-Farber Cancer Institute
- Investigators
- Nadine J McCleary, MD, MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00973440
- Sponsor's protocol ID
- 09-035
- Status last verified
- Oct 2013
- First submitted
- 8 Sep 2009
- Last updated
- 22 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-Based Comprehensive Geriatric Assessment in Oncology for Individuals 70 or Older With Colorectal, Breast or Lung Cancer
- ClinicalTrials.gov ID
- NCT00973440
- Acronym / sponsor ID
- 09-035
- Conditions
- Rectal Cancer, Breast Cancer, Lung Cancer
- Keywords
- geriatric assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- American Society of Clinical Oncology
- Study start
- Mar 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 9 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadine J McCleary, MD, MPH principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer and Breast Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2013.