ID

27270

Beskrivning

Memory Training Intervention for Breast Cancer Survivors; ODM derived from: https://clinicaltrials.gov/show/NCT01497015

Länk

https://clinicaltrials.gov/show/NCT01497015

Nyckelord

Versioner (1)
  1. 2017-11-06 2017-11-06 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

6 november 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01497015

Engelsk

Eligibility Breast Cancer NCT01497015

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. female gender (breast cancer is rare in men);
Beskrivning

Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
2. self-reported memory impairment and desire for treatment (to focus on bcs in greatest need);
Beskrivning

Memory impairment Patient Self-Report | Desire Therapeutic procedure | Treatment option Breast-Conserving Surgery

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0233794
UMLS CUI [1,2]
C0681906
UMLS CUI [2,1]
C0871633
UMLS CUI [2,2]
C0087111
UMLS CUI [3,1]
C0683525
UMLS CUI [3,2]
C0917927
3. first diagnosis of non-metastatic breast cancer (to control for multiple treatments or brain metastases in women with recurrent or metastatic disease);
Beskrivning

Breast Carcinoma Diagnosis First | Neoplasm Metastasis Absent | Control Therapeutic procedure multiple | Control Metastatic malignant neoplasm to brain | Control Recurrent disease | Control Neoplasm Metastasis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C0205435
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0243148
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C0439064
UMLS CUI [4,1]
C0243148
UMLS CUI [4,2]
C0220650
UMLS CUI [5,1]
C0243148
UMLS CUI [5,2]
C0277556
UMLS CUI [6,1]
C0243148
UMLS CUI [6,2]
C0027627
4. ≥ 1 year post-treatment including surgery, radiation, and/or chemotherapy (reduce confounding factors related to acute effects of treatment);32
Beskrivning

Therapeutic procedure Status post Year Quantity | Operative Surgical Procedures | Therapeutic radiology procedure | Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0231290
UMLS CUI [1,3]
C0439234
UMLS CUI [1,4]
C1265611
UMLS CUI [2]
C0543467
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0392920
5. age ≥ 40 years (our prior studies indicate approximately 75% of bcs meet this criterion and reduce sample variability);
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
6. post-menopausal (majority are post-menopausal at diagnosis and reduce sample variability); and
Beskrivning

Postmenopausal state

Datatyp

boolean

Alias
UMLS CUI [1]
C0232970
7. able to read, write, understand, and speak english (to ensure informed consent).
Beskrivning

Able to read English Language | Able to write English Language | Comprehension English Language | Able to speak English Language | Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0584993
UMLS CUI [2,2]
C0376245
UMLS CUI [3,1]
C0233733
UMLS CUI [3,2]
C0376245
UMLS CUI [4,1]
C0564215
UMLS CUI [4,2]
C0376245
UMLS CUI [5]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
women will be excluded if they have other co-morbidities or deficits that would sufficiently impair performance or inhibit cognitive training including:
Beskrivning

Comorbidity Impairing Performance of treatments | Comorbidity Inhibiting Cognitive training | Deficits Impairing Performance of treatments | Deficits Inhibiting Cognitive training

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0221099
UMLS CUI [1,3]
C0516960
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C3463820
UMLS CUI [2,3]
C1868940
UMLS CUI [3,1]
C2987487
UMLS CUI [3,2]
C0221099
UMLS CUI [3,3]
C0516960
UMLS CUI [4,1]
C2987487
UMLS CUI [4,2]
C3463820
UMLS CUI [4,3]
C1868940
1. substantial cognitive decline (score < 24 on the mini mental state exam (mmse);33
Beskrivning

Impaired cognition Mini-mental state examination

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0338656
UMLS CUI [1,2]
C0451306
2. history of stroke, encephalitis, traumatic brain injury, brain surgery, dementia, alzheimer disease, or parkinson disease;
Beskrivning

Cerebrovascular accident | Encephalitis | Brain Injuries | Operation on brain | Dementia | Alzheimer's Disease | Parkinson Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0014038
UMLS CUI [3]
C0270611
UMLS CUI [4]
C0195775
UMLS CUI [5]
C0497327
UMLS CUI [6]
C0002395
UMLS CUI [7]
C0030567
3. cranial radiation therapy or intrathecal therapy;
Beskrivning

Radiotherapy to head | intrathecal therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C1997353
UMLS CUI [2]
C1831734
4. current active major depression or substance abuse or history of bipolar disorder, psychosis, schizophrenia, or learning disability;
Beskrivning

Major Depressive Disorder | Substance Use Disorders | Bipolar Disorder | Psychotic Disorders | Schizophrenia | Learning Disabilities

Datatyp

boolean

Alias
UMLS CUI [1]
C1269683
UMLS CUI [2]
C0038586
UMLS CUI [3]
C0005586
UMLS CUI [4]
C0033975
UMLS CUI [5]
C0036341
UMLS CUI [6]
C0751265
5. history of or current other cancer except for basal cell skin cancer; or
Beskrivning

Cancer Other | Exception Basal cell carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
6. receiving other cognitive training (to avoid exposure to other training).
Beskrivning

Cognitive training Other

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1868940
UMLS CUI [1,2]
C0205394
Tillbaka till toppen

Similar models

Eligibility Breast Cancer NCT01497015

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
1. female gender (breast cancer is rare in men);
boolean
C0079399 (UMLS CUI [1])
Memory impairment Patient Self-Report | Desire Therapeutic procedure | Treatment option Breast-Conserving Surgery
Item
2. self-reported memory impairment and desire for treatment (to focus on bcs in greatest need);
boolean
C0233794 (UMLS CUI [1,1])
C0681906 (UMLS CUI [1,2])
C0871633 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0683525 (UMLS CUI [3,1])
C0917927 (UMLS CUI [3,2])
Breast Carcinoma Diagnosis First | Neoplasm Metastasis Absent | Control Therapeutic procedure multiple | Control Metastatic malignant neoplasm to brain | Control Recurrent disease | Control Neoplasm Metastasis
Item
3. first diagnosis of non-metastatic breast cancer (to control for multiple treatments or brain metastases in women with recurrent or metastatic disease);
boolean
C0678222 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
C0027627 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0243148 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0439064 (UMLS CUI [3,3])
C0243148 (UMLS CUI [4,1])
C0220650 (UMLS CUI [4,2])
C0243148 (UMLS CUI [5,1])
C0277556 (UMLS CUI [5,2])
C0243148 (UMLS CUI [6,1])
C0027627 (UMLS CUI [6,2])
Therapeutic procedure Status post Year Quantity | Operative Surgical Procedures | Therapeutic radiology procedure | Chemotherapy
Item
4. ≥ 1 year post-treatment including surgery, radiation, and/or chemotherapy (reduce confounding factors related to acute effects of treatment);32
boolean
C0087111 (UMLS CUI [1,1])
C0231290 (UMLS CUI [1,2])
C0439234 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C0543467 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0392920 (UMLS CUI [4])
Age
Item
5. age ≥ 40 years (our prior studies indicate approximately 75% of bcs meet this criterion and reduce sample variability);
boolean
C0001779 (UMLS CUI [1])
Postmenopausal state
Item
6. post-menopausal (majority are post-menopausal at diagnosis and reduce sample variability); and
boolean
C0232970 (UMLS CUI [1])
Able to read English Language | Able to write English Language | Comprehension English Language | Able to speak English Language | Informed Consent
Item
7. able to read, write, understand, and speak english (to ensure informed consent).
boolean
C0586740 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0584993 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
C0233733 (UMLS CUI [3,1])
C0376245 (UMLS CUI [3,2])
C0564215 (UMLS CUI [4,1])
C0376245 (UMLS CUI [4,2])
C0021430 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Comorbidity Impairing Performance of treatments | Comorbidity Inhibiting Cognitive training | Deficits Impairing Performance of treatments | Deficits Inhibiting Cognitive training
Item
women will be excluded if they have other co-morbidities or deficits that would sufficiently impair performance or inhibit cognitive training including:
boolean
C0009488 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0516960 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C3463820 (UMLS CUI [2,2])
C1868940 (UMLS CUI [2,3])
C2987487 (UMLS CUI [3,1])
C0221099 (UMLS CUI [3,2])
C0516960 (UMLS CUI [3,3])
C2987487 (UMLS CUI [4,1])
C3463820 (UMLS CUI [4,2])
C1868940 (UMLS CUI [4,3])
Impaired cognition Mini-mental state examination
Item
1. substantial cognitive decline (score < 24 on the mini mental state exam (mmse);33
boolean
C0338656 (UMLS CUI [1,1])
C0451306 (UMLS CUI [1,2])
Cerebrovascular accident | Encephalitis | Brain Injuries | Operation on brain | Dementia | Alzheimer's Disease | Parkinson Disease
Item
2. history of stroke, encephalitis, traumatic brain injury, brain surgery, dementia, alzheimer disease, or parkinson disease;
boolean
C0038454 (UMLS CUI [1])
C0014038 (UMLS CUI [2])
C0270611 (UMLS CUI [3])
C0195775 (UMLS CUI [4])
C0497327 (UMLS CUI [5])
C0002395 (UMLS CUI [6])
C0030567 (UMLS CUI [7])
Radiotherapy to head | intrathecal therapy
Item
3. cranial radiation therapy or intrathecal therapy;
boolean
C1997353 (UMLS CUI [1])
C1831734 (UMLS CUI [2])
Major Depressive Disorder | Substance Use Disorders | Bipolar Disorder | Psychotic Disorders | Schizophrenia | Learning Disabilities
Item
4. current active major depression or substance abuse or history of bipolar disorder, psychosis, schizophrenia, or learning disability;
boolean
C1269683 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
C0005586 (UMLS CUI [3])
C0033975 (UMLS CUI [4])
C0036341 (UMLS CUI [5])
C0751265 (UMLS CUI [6])
Cancer Other | Exception Basal cell carcinoma
Item
5. history of or current other cancer except for basal cell skin cancer; or
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
Cognitive training Other
Item
6. receiving other cognitive training (to avoid exposure to other training).
boolean
C1868940 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Tillbaka till toppen 

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