Cognition in Older Breast Cancer Survivors: Treatment Exposure, APOE and Smoking History
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Smoking Cessation |
| Therapuetic Areas: | Oncology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 60 - Any |
| Updated: | 4/6/2019 |
| Start Date: | April 8, 2014 |
| End Date: | April 2020 |
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.
MSK participants who previously consented to allostatic blood and saliva collection but have
not yet provided any allostatic blood or saliva samples for this study, will not be asked to
provide any further samples at follow-up. Participants who have consented to allostatic
sample collection and provided one set of allostatic blood and saliva samples at a previous
follow-up study visit will still be asked to provide a second set of samples at a later
follow-up. COH participants will continue to provide allostatic blood and saliva collection
as originally outlined
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.
MSK participants who previously consented to allostatic blood and saliva collection but have
not yet provided any allostatic blood or saliva samples for this study, will not be asked to
provide any further samples at follow-up. Participants who have consented to allostatic
sample collection and provided one set of allostatic blood and saliva samples at a previous
follow-up study visit will still be asked to provide a second set of samples at a later
follow-up. COH participants will continue to provide allostatic blood and saliva collection
as originally outlined
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:
- As per medical record or self-report, post-menopausal female
- As per medical record or self-report, age 60 or older at recruitment
- As per medical record or self-report, age 55 or older at the time of breast cancer
diagnosis
- As per medical record or self report, for cancers other than breast cancer or
non-melanoma/basal cell skin cancer/squamous cell skin cancer:
- Patient must be at least 3 years post diagnosis of that cancer
- Not received chemotherapy treatment or external beam radiation for that cancer
- As per medical record or self-report, 5-15 years post diagnosis of breast cancer at
the time of enrollment
- As per medical record or self-report, no evidence of any cancer disease
- American Joint Committee on Cancer (AJCC) stages 0-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
- English proficiency verified through an adapted Bidimensional acculturation
scale, score of 2.5 or above ***The scale will only be administered to
participants who report also speaking a language other than English.
For controls participants, eligibility includes:
- As per medical record or self-report, post-menopausal female
- As per medical record or self-report, age 60 and older at recruitment
- 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
°English proficiency verified through an adapted Bidimensional acculturation scale,
score of 2.5 or above. ***The scale will only be administered to participants who
report also speaking a language other than English.
- 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 except non-melanoma/basal cell skin cancer
squamous cell skin carcinoma
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 requiring
visit to the emergency room or hospitalization
- As per medical record or self report, diagnosis of major Axis I psychiatric
disorder including schizophrenia, manic-depressive disorder, or substance use
disorders
- 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, if the patient is
taking anti-depression or anti-anxiety medication, < 2 months on these medication
or a change in the prescribed dose in the past 2 months
- Previously or actively participating in protocol MSK IRB# 10-079
- For control participants, exclusion criteria include
- 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 requiring visit to the
emergency room or hospitalization
- As per self report, diagnosis of major Axis I psychiatric disorder including
schizophrenia, manic-depressive disorder, or substance use disorder
- 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,if the person is taking anti-anxiety or anit-depression
medication <2 months on these medications or a change in the prescribed dose in
the past 2 months
- Previously or actively participating in protocol 10-079
We found this trial at
2
sites
1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000
Principal Investigator: Tim Ahles, PhD
Phone: 646-888-0048
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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