Cognitive Function in Older Women With Stage I, Stage II, or Stage III Breast Cancer Receiving Hormone Therapy
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | May 20, 2008 | ||||
| Last Updated Date | November 30, 2011 | ||||
| Start Date ICMJE | October 2007 | ||||
| Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Impact of treatment with an aromatase inhibitor on cognitive function [ Time Frame: Prior to starting aromatase treatment and 6 months after starting the medication. ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Impact of treatment with an aromatase inhibitor on cognitive function [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00681928 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Cognitive Function in Older Women With Stage I, Stage II, or Stage III Breast Cancer Receiving Hormone Therapy | ||||
| Official Title ICMJE | The Effect of Aromatase Inhibition on the Cognitive Function of Older Patients With Breast Cancer | ||||
| Brief Summary | RATIONALE: Gathering information about cognitive function over time in postmenopausal women with breast cancer may help doctors learn about the long-term effects of aromatase inhibitor therapy and plan the best treatment. PURPOSE: This clinical trial is studying cognitive function in older postmenopausal women with stage I, stage II, or stage III breast cancer receiving hormone therapy and in healthy volunteers. |
||||
| Detailed Description | OBJECTIVES:
OUTLINE: Patients receive adjuvant anastrozole or letrozole in the absence of disease progression or unacceptable toxicity. Patients and healthy volunteers undergo cognitive function testing consisting of neuropsychological battery tests and complete self-reported questionnaires (e.g., Squire Memory Self-Rating Questionnaire, and FACT-B Quality of Life Measure) regarding cognitive ability, quality of life, fatigue, and psychosocial status. Patients and healthy volunteers also undergo geriatric assessment at baseline and after 6 months of initiation with aromatase inhibitor therapy. |
||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Breast cancer patients and healthy control subjects |
||||
| Condition ICMJE | Breast Cancer | ||||
| Intervention ICMJE |
|
||||
| Study Group/Cohort (s) |
|
||||
| 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 ICMJE | Completed | ||||
| Enrollment ICMJE | 72 | ||||
| Completion Date | January 2011 | ||||
| Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
|
||||
| Gender | Female | ||||
| Ages | 65 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00681928 | ||||
| Other Study ID Numbers ICMJE | 07006, P30CA033572, CHNMC-07006, CDR0000589001 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | City of Hope Medical Center | ||||
| Study Sponsor ICMJE | City of Hope Medical Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | City of Hope Medical Center | ||||
| Verification Date | November 2011 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||