Cognitive/Functional EffectsNCT00769951
Study of Physical and Mental Health of Older Patients With Newly Diagnosed Cancer
An observational study of Cognitive/Functional Effects and Depression, run by Case Comprehensive Cancer Center at 2 sites in United States.
Trial summary
RATIONALE: Gathering information from older patients with newly diagnosed cancer may help doctors learn more about the risks of functional decline. PURPOSE: This studying is looking at the physical and mental health of older patients with newly diagnosed cancer. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cognitive/Functional Effects, Depression, Hematopoietic/Lymphoid Cancer
- What is being tested?
- medical chart review, questionnaire administration and cognitive assessment
- Type of treatment
- Surgery or procedure
- How many people
- 46 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2008to Sep 2011
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Primary care clinics
DISEASE CHARACTERISTICS:
- Histologically confirmed newly diagnosed cancer
- Any stage disease
- At increased risk for functional decline and mortality within the next year as per the Vulnerable Elders Survey (VES-13) screening tool (score ≥ 3)
- Seeking care at the Ireland Cancer Center (University hospitals and all other satellite sites)
- Patients with a pre-existing cancer diagnosis and a geriatric syndrome referred directly to the Senior Adult Oncology Program by their providers for a geriatric-oncology consultative evaluation are not eligible
PATIENT CHARACTERISTICS:
- Able to speak and comprehend English
- Able to understand and willing to sign a written informed consent
PRIOR CONCURRENT THERAPY:
- Not specified
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
UHHS Chagrin Highlands Medical Center
Cleveland, Ohio, 44122
About this study
Official title: The Geriatric-Oncology Database: A Resource for Advancing Research in Older Cancer Patients
RATIONALE: Gathering information from older patients with newly diagnosed cancer may help doctors learn more about the risks of functional decline.
PURPOSE: This studying is looking at the physical and mental health of older patients with newly diagnosed cancer.
Read the detailed description
OBJECTIVES:
- To create a Geriatric-Oncology database of patients 65 years of age and older with newly diagnosed cancer who have been identified as being at increased risk of functional decline and mortality within a year.
- To enhance the Geriatric-Oncology Database by linking it to the Central Medicare Services (CMS) Database and the Ohio Death Files.
OUTLINE: This is a multicenter study.
Patients undergo a 1-hour comprehensive geriatric assessment at baseline and periodically during the study as part of routine care. The assessments include the Lawton's nine-item Instrumental Activities of Daily Living (IADL); the Katz's Activity of Daily Living (ADL); the Timed Up and Go Test; the Karnofsky Physician-Rated Performance Rating Scale (KPS); the number of falls in the past 6 months; the Mini Nutritional Assessment (MNA); the Body Mass Index; the percent of unintentional weight loss in the past 6 months; the Medical Outcomes Study (MOS) Social Support Subscale (emotional/information and tangible subscales); the MOS Social Activity Limitations Measures; the Charlson Comorbidity Index; the Cumulative Index Rating Scale Geriatrics (CIRS-G); the ACE-27; the Folstein's Mini-Mental State Examination (MMSE); the Geriatric Depression Scale (GDS); the Functional Pain Scale; and a list of medications.
Data will be obtained from patients medical records at baseline, 6 months, 1 year, and 3 years. At completion of 1 and 3 years of follow up, the Geriatric-Oncology Database will be linked to the Central Medicare and Medicaid Services (CMS) Database and the Ohio Death Files.
- Conditions
- Cognitive/Functional Effects, Depression, Hematopoietic/Lymphoid Cancer, Malnutrition, Pain, Psychosocial Effects of Cancer and Its Treatment
- Being tested
- medical chart review, questionnaire administration, cognitive assessment, psychosocial assessment and care, quality-of-life assessment
- Keywords
- pain, depression, weight changes, cognitive/functional effects, malnutrition, psychosocial effects of cancer and its treatment, unspecified adult solid tumor, protocol specific, hematopoietic/lymphoid cancer
- Medical subject headings
- Depression, Hematologic Neoplasms, Malnutrition, Pain, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical chart reviewOther
Data will be obtained from patients medical records at baseline, 6 months, 1 year, and 3 years.
questionnaire administrationOther
Patients undergo a 1-hour comprehensive geriatric assessment at baseline and periodically during the study as part of routine care. The assessments include the Lawton's nine-item Instrumental Activities of Daily Living (IADL); the Katz's Activity of Daily Living (ADL); the Timed Up and Go Test; the Karnofsky Physician-Rated Performance Rating Scale (KPS); the number of falls in the past 6 months; the Mini Nutritional Assessment (MNA); the Body Mass Index; the percent of unintentional weight loss in the past 6 months; the Medical Outcomes Study (MOS) Social Support Subscale (emotional/information and tangible subscales); the MOS Social Activity Limitations Measures; the Charlson Comorbidity Index; the Cumulative Index Rating Scale Geriatrics (CIRS-G); the ACE-27; the Folstein's Mini-Mental State Examination (MMSE); the Geriatric Depression Scale (GDS); the Functional Pain Scale; and a list of medications.
cognitive assessmentProcedure or surgery
Patients undergo a 1-hour comprehensive geriatric assessment at baseline and periodically during the study as part of routine care.
psychosocial assessment and careProcedure or surgery
Patients undergo a 1-hour comprehensive geriatric assessment at baseline and periodically during the study as part of routine care.
quality-of-life assessmentProcedure or surgery
Patients undergo a 1-hour comprehensive geriatric assessment at baseline and periodically during the study as part of routine care.
What is being measured
The primary outcome is the main question the study is designed to answer.
Creation of a Geriatric-Oncology database
Measured: Data will be obtained from patients medical records at baseline, 6 months, 1 year, and 3 years.
Enhancement of the Geriatric-Oncology database by linking it to the Central Medicare Services Database and the Ohio Death Files
Measured: At completion of 1 and 3 years of follow up, the Geriatric-Oncology Database will be linked to the Central Medicare and Medicaid Services (CMS) Database and the Ohio Death Files.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2008 (estimated)
- Study startFeb 2008
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive/Functional EffectsStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Cynthia Owusu, MD, MSC, Study chair, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00769951
- Sponsor's protocol ID
- CASE9Y07
- Status last verified
- Jul 2020
- First submitted
- 8 Oct 2008
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Geriatric-Oncology Database: A Resource for Advancing Research in Older Cancer Patients
- ClinicalTrials.gov ID
- NCT00769951
- Acronym / sponsor ID
- CASE9Y07
- Conditions
- Cognitive/Functional Effects, Depression, Hematopoietic/Lymphoid Cancer, Malnutrition, Pain, Psychosocial Effects of Cancer and Its Treatment
- Keywords
- pain, depression, weight changes, cognitive/functional effects, malnutrition, psychosocial effects of cancer and its treatment, unspecified adult solid tumor, protocol specific, hematopoietic/lymphoid cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 9 Oct 2008 (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.
RATIONALE: Gathering information from older patients with newly diagnosed cancer may help doctors learn more about the risks of functional decline.
PURPOSE: This studying is looking at the physical and mental health of older patients with newly diagnosed cancer.
Detailed description
OBJECTIVES:
- To create a Geriatric-Oncology database of patients 65 years of age and older with newly diagnosed cancer who have been identified as being at increased risk of functional decline and mortality within a year.
- To enhance the Geriatric-Oncology Database by linking it to the Central Medicare Services (CMS) Database and the Ohio Death Files.
OUTLINE: This is a multicenter study.
Patients undergo a 1-hour comprehensive geriatric assessment at baseline and periodically during the study as part of routine care. The assessments include the Lawton's nine-item Instrumental Activities of Daily Living (IADL); the Katz's Activity of Daily Living (ADL); the Timed Up and Go Test; the Karnofsky Physician-Rated Performance Rating Scale (KPS); the number of falls in the past 6 months; the Mini Nutritional Assessment (MNA); the Body Mass Index; the percent of unintentional weight loss in the past 6 months; the Medical Outcomes Study (MOS) Social Support Subscale (emotional/information and tangible subscales); the MOS Social Activity Limitations Measures; the Charlson Comorbidity Index; the Cumulative Index Rating Scale Geriatrics (CIRS-G); the ACE-27; the Folstein's Mini-Mental State Examination (MMSE); the Geriatric Depression Scale (GDS); the Functional Pain Scale; and a list of medications.
Data will be obtained from patients medical records at baseline, 6 months, 1 year, and 3 years. At completion of 1 and 3 years of follow up, the Geriatric-Oncology Database will be linked to the Central Medicare and Medicaid Services (CMS) Database and the Ohio Death Files.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Primary care clinics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medical chart reviewData will be obtained from patients medical records at baseline, 6 months, 1 year, and 3 years. | Other | – |
| questionnaire administrationPatients undergo a 1-hour comprehensive geriatric assessment at baseline and periodically during the study as part of routine care. The assessments include the Lawton's nine-item Instrumental Activities of Daily Living (IADL); the Katz's Activity of Daily Living (ADL); the Timed Up and Go Test; the Karnofsky Physician-Rated Performance Rating Scale (KPS); the number of falls in the past 6 months; the Mini Nutritional Assessment (MNA); the Body Mass Index; the percent of unintentional weight loss in the past 6 months; the Medical Outcomes Study (MOS) Social Support Subscale (emotional/information and tangible subscales); the MOS Social Activity Limitations Measures; the Charlson Comorbidity Index; the Cumulative Index Rating Scale Geriatrics (CIRS-G); the ACE-27; the Folstein's Mini-Mental State Examination (MMSE); the Geriatric Depression Scale (GDS); the Functional Pain Scale; and a list of medications. | Other | – |
| cognitive assessmentPatients undergo a 1-hour comprehensive geriatric assessment at baseline and periodically during the study as part of routine care. | Procedure or surgery | – |
| psychosocial assessment and carePatients undergo a 1-hour comprehensive geriatric assessment at baseline and periodically during the study as part of routine care. | Procedure or surgery | – |
| quality-of-life assessmentPatients undergo a 1-hour comprehensive geriatric assessment at baseline and periodically during the study as part of routine care. | Procedure or surgery | – |
Primary outcome
Creation of a Geriatric-Oncology database
Time frame: Data will be obtained from patients medical records at baseline, 6 months, 1 year, and 3 years.
Enhancement of the Geriatric-Oncology database by linking it to the Central Medicare Services Database and the Ohio Death Files
Time frame: At completion of 1 and 3 years of follow up, the Geriatric-Oncology Database will be linked to the Central Medicare and Medicaid Services (CMS) Database and the Ohio Death Files.
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 27 Jul 2020.
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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.
Cynthia Owusu, MD, MSC study chair
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive/Functional Effects and Depression, run by Case Comprehensive Cancer Center at 2 sites 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?
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 27 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Creation of a Geriatric-Oncology database (time frame: Data will be obtained from patients medical records at baseline, 6 months, 1 year, and 3 years.). The study lists 2 primary outcomes in all. 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 27 Jul 2020.