Breast CancerNCT00873600
Outpatient Health Care Program for Older Patients Receiving Chemotherapy for Newly Diagnosed Breast Cancer or Colon Cancer
An observational study of Breast Cancer and Cognitive/Functional Effects, run by Case Comprehensive Cancer Center.
Trial summary
RATIONALE: Gathering health information from older patients undergoing chemotherapy may help doctors plan better treatment and improve the quality of life for these patients. PURPOSE: This randomized clinical trial is studying how well an outpatient health care program works for older patients receiving chemotherapy… 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?
- chemotherapy, medical chart review and questionnaire administration
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2007to not given
- 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 adenocarcinoma, including one of the following:
- Breast cancer (female), meeting the following criteria:
- Stage I-III (T1-4, N0-3, M0) disease
- Has undergone complete surgical removal of invasive cancer by mastectomy or lumpectomy
- Has undergone either sentinel lymph node dissection or axillary lymph node dissection with adequate TNM staging
- Colon cancer (male or female), meeting the following criteria:
- Stage I-III (T1-3, any N, M0) disease
- Has undergone appropriate surgical resection with TNM staging
- Newly diagnosed disease
- Scheduled to receive chemotherapy
- Agrees to receive chemotherapy AND is able to receive chemotherapy within 3 months after surgery
- No distant metastases
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- Life expectancy ≥ 6 months
- Fluent in English
- Not living in a nursing home
- No end-stage disease
- No severe dementia
- No other clinically active malignancy within the past 5 years or within 3 months after diagnosis of current malignancy
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy for the malignancy
- More than 1 year since prior treatment on an inpatient/outpatient geriatric evaluation and management unit
About this study
Official title: A Randomized Controlled Trial of Outpatient Geriatric Evaluation and Management Among Older Patients With Breast and Colon Cancer
RATIONALE: Gathering health information from older patients undergoing chemotherapy may help doctors plan better treatment and improve the quality of life for these patients.
PURPOSE: This randomized clinical trial is studying how well an outpatient health care program works for older patients receiving chemotherapy for newly diagnosed breast cancer or colon cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the effect of a 1-year geriatric evaluation and management (GEM) program on adherence to adjuvant chemotherapy (defined as tolerance and timely completion of planned dose) in patients with newly diagnosed breast or colon cancer.
Secondary
- Evaluate the effect of a 1-year GEM program on the health-related quality of life and functional, cognitive, and mental status of these patients.
- Evaluate the effect of a 1-year GEM program on 3-year disease-free survival of these patients.
- Compare the number of emergency room visits, acute hospitalizations, and associated Medicare costs within the first 12 months following randomization to a GEM program vs no program.
OUTLINE: Patients are stratified according to tumor site (breast vs colon). Patients are randomized to 1 of 2 arms.
- Arm I (intervention): Patients complete health-related quality-of-life (QOL) and comprehensive geriatric assessment questionnaires at baseline, within 30 days after chemotherapy or at 6 months, and then at 12-13 months to assess functional status (i.e., activities of daily living), comorbidity (i.e., medical problems), medications, mood and memory, nutrition, and social support from family members and friends. Patients receive a home visit from a social worker and visit the Senior Adult Oncology clinic within 1 month after the first course of chemotherapy. The clinic staff develops an individualized care plan for the patient and communicates the results of the assessment questionnaires and their recommendations (e.g., medication and/or specialty referrals) to the patient's primary care provider and oncologist. The staff meets weekly to monitor and update the patient care plan. Patients are followed in the Senior Adult Oncology clinic at least every 3 months for 1 year. Follow-up telephone calls and in-home visits are also conducted as needed. Patients are also assessed prior to each course of chemotherapy for toxicities related to the chemotherapy.
- Arm II (control): Patients complete a health-related QOL questionnaire at baseline, within 30 days after chemotherapy or at 6 months, and then at 12-13 months. Patients receive oncology and primary care by their usual health care providers.
After completion of the study intervention, patients' medical charts are reviewed periodically for up to 2 years.
- Conditions
- Breast Cancer, Cognitive/Functional Effects, Colorectal Cancer, Psychosocial Effects of Cancer and Its Treatment
- Being tested
- chemotherapy, medical chart review, questionnaire administration, adjuvant therapy, assessment of therapy complications
- Keywords
- cognitive/functional effects, psychosocial effects of cancer and its treatment, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, adenocarcinoma of the colon, stage I colon cancer, stage II colon cancer, stage III 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.
chemotherapyDrug
medical chart reviewOther
questionnaire administrationOther
adjuvant therapyProcedure or surgery
assessment of therapy complicationsProcedure or surgery
cognitive assessmentProcedure or surgery
psychosocial assessment and careProcedure or surgery
quality-of-life assessmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Chemotherapy tolerability as measured by dose reduction, treatment delay, and incidence of grade 3-5 toxicities
Secondary outcomes (3)
Mean change in comprehensive geriatric assessment scores and quality-of-life scores from baseline to post-chemotherapy and from baseline to 12 months following randomization
Number of emergency room visits, acute hospitalizations, and associated Medicare costs within the first 12 months following randomization
3-year disease-free survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2009 (estimated)
- Study startOct 2007
Why it stopped: No 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Cynthia Owusu, MD, MSC, Principal investigator, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00873600
- Sponsor's protocol ID
- CASE4Y07
- Other IDs
- P30CA043703, CASE4Y07
- Status last verified
- Mar 2015
- First submitted
- 31 Mar 2009
- Last updated
- 19 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Outpatient Geriatric Evaluation and Management Among Older Patients With Breast and Colon Cancer
- ClinicalTrials.gov ID
- NCT00873600
- Acronym / sponsor ID
- CASE4Y07
- Conditions
- Breast Cancer, Cognitive/Functional Effects, Colorectal Cancer, Psychosocial Effects of Cancer and Its Treatment
- Keywords
- cognitive/functional effects, psychosocial effects of cancer and its treatment, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, adenocarcinoma of the colon
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2007
- First posted
- 1 Apr 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.
RATIONALE: Gathering health information from older patients undergoing chemotherapy may help doctors plan better treatment and improve the quality of life for these patients.
PURPOSE: This randomized clinical trial is studying how well an outpatient health care program works for older patients receiving chemotherapy for newly diagnosed breast cancer or colon cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the effect of a 1-year geriatric evaluation and management (GEM) program on adherence to adjuvant chemotherapy (defined as tolerance and timely completion of planned dose) in patients with newly diagnosed breast or colon cancer.
Secondary
- Evaluate the effect of a 1-year GEM program on the health-related quality of life and functional, cognitive, and mental status of these patients.
- Evaluate the effect of a 1-year GEM program on 3-year disease-free survival of these patients.
- Compare the number of emergency room visits, acute hospitalizations, and associated Medicare costs within the first 12 months following randomization to a GEM program vs no program.
OUTLINE: Patients are stratified according to tumor site (breast vs colon). Patients are randomized to 1 of 2 arms.
- Arm I (intervention): Patients complete health-related quality-of-life (QOL) and comprehensive geriatric assessment questionnaires at baseline, within 30 days after chemotherapy or at 6 months, and then at 12-13 months to assess functional status (i.e., activities of daily living), comorbidity (i.e., medical problems), medications, mood and memory, nutrition, and social support from family members and friends. Patients receive a home visit from a social worker and visit the Senior Adult Oncology clinic within 1 month after the first course of chemotherapy. The clinic staff develops an individualized care plan for the patient and communicates the results of the assessment questionnaires and their recommendations (e.g., medication and/or specialty referrals) to the patient's primary care provider and oncologist. The staff meets weekly to monitor and update the patient care plan. Patients are followed in the Senior Adult Oncology clinic at least every 3 months for 1 year. Follow-up telephone calls and in-home visits are also conducted as needed. Patients are also assessed prior to each course of chemotherapy for toxicities related to the chemotherapy.
- Arm II (control): Patients complete a health-related QOL questionnaire at baseline, within 30 days after chemotherapy or at 6 months, and then at 12-13 months. Patients receive oncology and primary care by their usual health care providers.
After completion of the study intervention, patients' medical charts are reviewed periodically for up to 2 years.
Study design
- Observational model
- Case-control
- 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 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 |
|---|---|---|
| chemotherapy | Drug | – |
| medical chart review | Other | – |
| questionnaire administration | Other | – |
| adjuvant therapy | Procedure or surgery | – |
| assessment of therapy complications | Procedure or surgery | – |
| cognitive assessment | Procedure or surgery | – |
| psychosocial assessment and care | Procedure or surgery | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Chemotherapy tolerability as measured by dose reduction, treatment delay, and incidence of grade 3-5 toxicities
3 secondary outcomes
Mean change in comprehensive geriatric assessment scores and quality-of-life scores from baseline to post-chemotherapy and from baseline to 12 months following randomization
Number of emergency room visits, acute hospitalizations, and associated Medicare costs within the first 12 months following randomization
3-year disease-free survival
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2015.
- Clinical trial summary from the National Cancer Institute's PDQ® databaseLink provided by the sponsor.
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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 principal investigator
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
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.
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: withdrawn, as of the sponsor's last update on 19 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Chemotherapy tolerability as measured by dose reduction, treatment delay, and incidence of grade 3-5 toxicities. 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 19 Mar 2015.