Cognition in Older Breast Cancer Survivors: Treatment Exposure, APOE and Smoking History

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborators:
City of Hope Medical Center
Boston University
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT02122107
First received: April 10, 2014
Last updated: July 17, 2014
Last verified: July 2014

April 10, 2014
July 17, 2014
April 2014
April 2017   (final data collection date for primary outcome measure)
neurocognitive outcomes [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
Neurocognitive tests will be performed longitudinally at 4 time points, enrollment, and 8, 16, and 24 months post enrollment.The participant will also be asked to complete two surveys.
Same as current
Complete list of historical versions of study NCT02122107 on ClinicalTrials.gov Archive Site
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Cognition in Older Breast Cancer Survivors: Treatment Exposure, APOE and Smoking History
Cognition in Older Breast Cancer Survivors: Treatment Exposure, APOE and Smoking History

In this study,the investigators are looking to see how older women who are survivors of breast cancer and either did or did not receive chemotherapy are affected by treatment, compared to older women who have never had cancer. Thinking and memory abilities normally decrease with age and the investigators want to see if the long-term effects of cancer treatments may make these problems worse. The investigators will also look at how thinking and memory abilities of older women are affected by genetics and smoking history. Genetics and other factors may affect the brain's chemicals or structure, and may either protect against the negative effects on thinking or make someone more at risk for them.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

Blood

Non-Probability Sample

We propose to enroll 480 participants into the study across the 2 sites: 240 participants (160 patients, 80 controls) from MSKCC and 240 participants from City of Hope (160 survivors, 80 controls).

Breast Cancer Survivors
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  • breast cancer survivors who had received chemotherapy
    Participants will complete all assessments at enrollment and approximately (+/- 4 weeks) at 8, 16, and 24 month follow-ups. We will screen participants to ensure that 50% of each group will report no smoking history and 50% will report a smoking history. Blood samples will be collected by trained staff one time at baseline.
  • breast cancer survivors who had not received chemotherapy
    Participants will complete all assessments at enrollment and approximately (+/- 4 weeks) at 8, 16, and 24 month follow-ups. We will screen participants to ensure that 50% of each group will report no smoking history and 50% will report a smoking history. Blood samples will be collected by trained staff one time at baseline.
  • non-cancer controls matched by age,education, and race
    Participants will complete all assessments at enrollment and approximately (+/- 4 weeks) at 8, 16, and 24 month follow-ups. We will screen participants to ensure that 50% of each group will report no smoking history and 50% will report a smoking history. Blood samples will be collected by trained staff one time at baseline.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
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April 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • The neuropsychological assessments were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefore, participants must be able to communicate in English to complete the tests. Friend nominated, non-cancer controls will be frequency matched on age (+/- 5 years), education (less than college vs. some college and above), and race will be recruited using the same eligibility criteria as survivors except for no history of cancer.

For cancer patients, eligibility includes:

  • Female
  • Age 65 and older at recruitment
  • Age 60 or older at the time of diagnosis 5-15 years post diagnosis at the time of enrollment and no evidence of disease
  • American Joint Committee on Cancer (AJCC) stages I-III breast cancer survivor as per clinical judgment/electronic medical record (EMR)
  • Score of < 11 on the Blessed Orientation-Memory-Concentration Test (BOMC)
  • In the judgment of the consenting professional, able to communicate well enough in English through verbal and written communication to complete the study assessments and provide informed consent
  • If a tobacco smoker, started smoking prior to age 20 as per self report

For controls, eligibility includes:

  • female
  • Age 65 and older
  • In the judgment of the consenting professional, able to communicate well enough in English through verbal and written communication to complete the study assessments and provide informed consent
  • Score of < 11 on the Blessed Orientation-Memory-Concentration Test (BOMC)
  • As per self report, no history of treatment with chemotherapy
  • As per self report no history of cancer
  • If a tobacco smoker, started smoking prior to age 20 as per self report

Exclusion Criteria:

  • For cancer patients, exclusion criteria includes:

    • As per medical record or self report, diagnosis of neurodegenerative disorder that affects cognitive function (e.g., Alzheimer's, Parkinson's, Multiple Sclerosis, dementia, seizure disorders, etc)
    • As per medical record or self report, history of stroke or head injury with loss of consciousness for 30+ minutes
    • As per medical record or self report, diagnosis of major Axis I psychiatric disorder including schizophrenia, manic-depressive disorder, or substance use disorder
    • As per medical record or self report, history of other cancer with the exception of non-melanoma skin cancer and women who completed treatment for a previous cancer o An exception: women who completed treatment for a previous cancer at least 5 years ago and have not undergone any chemotherapy or hormonal therapy.

As per self report or in the judgment of the consenting professional, visual or auditory impairment that would preclude ability to complete assessments

  • As per self report or as confirmed by the medical record, anxiety or depression medications use for <2 months or unstable. For control participants, exclusion criteria includes
  • As per self report, diagnosis of neurodegenerative disorder that affects cognitive function (e.g., Alzheimer's, Parkinson's, Multiple Sclerosis, dementia, seizure disorders, etc.)
  • As per self report, history of stroke or head injury with loss of consciousness for 30+ minutes
  • As per self report, diagnosis of major Axis I psychiatric disorder including schizophrenia, manic-depressive disorder, or substance use disorder
  • As per self report, history of any cancer (except non-melanoma skin cancer)
  • As per self report, or in the judgment of the consenting professional, visual or auditory impairment that would preclude ability to complete assessments
  • As per self report, anxiety or depression medications use for <2 mos or unstable
Female
65 Years and older
Yes
Contact: Tim Ahles, PhD 646-888-0048
Contact: Elizabeth Ryan, PhD 646-888-0044
United States
 
NCT02122107
14-071
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Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
  • City of Hope Medical Center
  • Boston University
Principal Investigator: Tim Ahles, PhD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP