Breast CancerNCT00740961
Older Patients With Newly Diagnosed Breast Cancer or Colon Cancer
An observational study of Breast Cancer and Cognitive/Functional Effects, run by Case Comprehensive Cancer Center at 5 sites in United States.
Trial summary
RATIONALE: Learning about changes over time in older patients' ability to function after receiving chemotherapy for breast or colon cancer may help doctors learn about the long-term effects of treatment and plan the best treatment. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Breast Cancer, Cognitive/Functional Effects, Colorectal Cancer
- What is being tested?
- compliance monitoring, systemic chemotherapy and medical chart review
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 63 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 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 clinic
DISEASE CHARACTERISTICS:
- Histologically confirmed breast or colon cancer
- Newly diagnosed disease
- Any stage disease
- Undergoing treatment at the Ireland Cancer Center, University Hospitals Case Medical Center Site
- Scheduled to start a new chemotherapy regimen (objective II only)
- Not concurrently enrolled in a GEM trial (objectives II, III, and IV)
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Understands English
- Menopausal status not specified
PRIOR CONCURRENT THERAPY:
- See Diseases Characteristics
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
UH-LUICC
Mentor, Ohio, 44060
UH-Chagrin Highlands
Orange, Ohio, 44122
UH-Green Road
South Euclid, Ohio, 44121
UH-Westlake
Westlake, Ohio, 44145
About this study
Official title: The Vulnerable Elders Survey Study of Older Cancer Patients
RATIONALE: Learning about changes over time in older patients' ability to function after receiving chemotherapy for breast or colon cancer may help doctors learn about the long-term effects of treatment and plan the best treatment.
PURPOSE: This clinical trial is studying older patients with newly diagnosed breast cancer or colon cancer.
Read the detailed description
OBJECTIVES:
- Determine the correlation between the Vulnerable Elders Survey (VES-13) and the battery of Comprehensive Geriatric Assessment tools among breast and colon cancer patients, 65 years and older, in an outpatient setting.
- Assess and compare the abilities of the VES-13 and the battery of Comprehensive Geriatric Assessment tools to predict chemotherapy adherence among these patients.
- Examine the validity of the VES-13 screening tool to identify increased risk of death from all causes at one year after initial VES-13 screening in these patients.
- Examine the validity of the VES-13 screening tool to identify increased risk of functional decline at one year after initial VES-13 screening in these patients.
OUTLINE: Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
Patients are followed for 1 year for chemotherapy adherence and survival.
- Conditions
- Breast Cancer, Cognitive/Functional Effects, Colorectal Cancer, Psychosocial Effects of Cancer and Its Treatment
- Being tested
- compliance monitoring, systemic chemotherapy, medical chart review, study of socioeconomic and demographic variables, survey administration
- Keywords
- psychosocial effects of cancer and its treatment, cognitive/functional effects, breast cancer, colon cancer
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
compliance monitoringBehavioural
Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
systemic chemotherapyDrug
Learning about changes over time in older patients' ability to function after receiving chemotherapy for breast or colon cancer
medical chart reviewOther
A limited review of medical records for the sole purpose of evaluating patients for study eligibility will be undertaken by the research team.
study of socioeconomic and demographic variablesOther
Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
survey administrationOther
Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
cognitive assessmentProcedure or surgery
Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
psychosocial assessment and careProcedure or surgery
Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
| Study group | Role | What they receive |
|---|---|---|
| Patients with cancer | Patients ≥ 65 years with new stage I-III breast or colon cancer seeking care. Patients will be matched on baseline scores, age and sex. Patients will be age and sex matched due to the known relation between inflammatory markers and demographic characteristics39,40, and will be matched on baseline VES scores to ensure similar baseline VES-13 scores between groups and which will then allow us to then assess effect of cancer treatment on outcomes. Receives: Behavioral: compliance monitoring; Drug: systemic chemotherapy; Other: medical chart review; Other: study of socioeconomic and demographic variables; Other: survey administration; Procedure: cognitive assessment; Procedure: psychosocial assessment and care | |
| Patients without cancer | non-cancer patients, seeking care at out-patient clinics Receives: Behavioral: compliance monitoring; Other: medical chart review; Other: study of socioeconomic and demographic variables; Other: survey administration; Procedure: cognitive assessment; Procedure: psychosocial assessment and care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of impaired domains on Comprehensive Geriatric Assessment (CGA)
Measured: at baseline and 12 months later.
Chemotherapy adherence as measured by dose reduction, dose delay, and grade 3-5 toxicities
Measured: Patients are followed for 1 year for chemotherapy adherence and survival.
Vulnerable Elders Survey scores
Measured: at baseline and 12 months later.
Functional decline
Measured: at baseline and 12 months later.
Time to death
Measured: Patients are followed for 1 year for chemotherapy adherence and survival.
Secondary outcomes (1)
Scores of individual battery of tools included in the CGA
Measured: at baseline and 12 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2008 (estimated)
- Study startMar 2008
- Primary completionSep 2011
- Study completionSep 2011
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- 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
- NCT00740961
- Sponsor's protocol ID
- CASE8Y07
- Status last verified
- Jul 2020
- First submitted
- 22 Aug 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 Vulnerable Elders Survey Study of Older Cancer Patients
- ClinicalTrials.gov ID
- NCT00740961
- Acronym / sponsor ID
- CASE8Y07
- Conditions
- Breast Cancer, Cognitive/Functional Effects, Colorectal Cancer, Psychosocial Effects of Cancer and Its Treatment
- Keywords
- psychosocial effects of cancer and its treatment, cognitive/functional effects, breast cancer, colon cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 25 Aug 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: Learning about changes over time in older patients' ability to function after receiving chemotherapy for breast or colon cancer may help doctors learn about the long-term effects of treatment and plan the best treatment.
PURPOSE: This clinical trial is studying older patients with newly diagnosed breast cancer or colon cancer.
Detailed description
OBJECTIVES:
- Determine the correlation between the Vulnerable Elders Survey (VES-13) and the battery of Comprehensive Geriatric Assessment tools among breast and colon cancer patients, 65 years and older, in an outpatient setting.
- Assess and compare the abilities of the VES-13 and the battery of Comprehensive Geriatric Assessment tools to predict chemotherapy adherence among these patients.
- Examine the validity of the VES-13 screening tool to identify increased risk of death from all causes at one year after initial VES-13 screening in these patients.
- Examine the validity of the VES-13 screening tool to identify increased risk of functional decline at one year after initial VES-13 screening in these patients.
OUTLINE: Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
Patients are followed for 1 year for chemotherapy adherence and survival.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with cancer | – | Behavioral: compliance monitoring, Drug: systemic chemotherapy, Other: medical chart review, Other: study of socioeconomic and demographic variables, Other: survey administration, Procedure: cognitive assessment, Procedure: psychosocial assessment and carePatients ≥ 65 years with new stage I-III breast or colon cancer seeking care. Patients will be matched on baseline scores, age and sex. Patients will be age and sex matched due to the known relation between inflammatory markers and demographic characteristics39,40, and will be matched on baseline VES scores to ensure similar baseline VES-13 scores between groups and which will then allow us to then assess effect of cancer treatment on outcomes. |
| Patients without cancer | – | Behavioral: compliance monitoring, Other: medical chart review, Other: study of socioeconomic and demographic variables, Other: survey administration, Procedure: cognitive assessment, Procedure: psychosocial assessment and carenon-cancer patients, seeking care at out-patient clinics |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Primary Care clinic
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 |
|---|---|---|
| compliance monitoringPatients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality. | Behavioural | Patients with cancer, Patients without cancer |
| systemic chemotherapyLearning about changes over time in older patients' ability to function after receiving chemotherapy for breast or colon cancer | Drug | Patients with cancer |
| medical chart reviewA limited review of medical records for the sole purpose of evaluating patients for study eligibility will be undertaken by the research team. | Other | Patients with cancer, Patients without cancer |
| study of socioeconomic and demographic variablesPatients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality. | Other | Patients with cancer, Patients without cancer |
| survey administrationPatients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality. | Other | Patients with cancer, Patients without cancer |
| cognitive assessmentPatients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality. | Procedure or surgery | Patients with cancer, Patients without cancer |
| psychosocial assessment and carePatients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality. | Procedure or surgery | Patients with cancer, Patients without cancer |
Primary outcome
Number of impaired domains on Comprehensive Geriatric Assessment (CGA)
Time frame: at baseline and 12 months later.
Chemotherapy adherence as measured by dose reduction, dose delay, and grade 3-5 toxicities
Time frame: Patients are followed for 1 year for chemotherapy adherence and survival.
Vulnerable Elders Survey scores
Time frame: at baseline and 12 months later.
Functional decline
Time frame: at baseline and 12 months later.
Time to death
Time frame: Patients are followed for 1 year for chemotherapy adherence and survival.
1 secondary outcome
Scores of individual battery of tools included in the CGA
Time frame: at baseline and 12 months later
Results and safety
The study was stopped early (reason given: low accrual). Results are not available in the source record.
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
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Cognitive/Functional Effects, run by Case Comprehensive Cancer Center at 5 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: stopped early, 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 5 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 was stopped early (reason given: low accrual). Results are not available in the source record.
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?
Number of impaired domains on Comprehensive Geriatric Assessment (CGA) (time frame: at baseline and 12 months later.). The study lists 5 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.