ID

27270

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT01497015

Stichworte

Versionen (1)
  1. 06.11.17 06.11.17 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

6. November 2017

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Breast Cancer NCT01497015

Englisch

Eligibility Breast Cancer NCT01497015

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Gender

Datentyp

boolean

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

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

Datentyp

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);
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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);
Beschreibung

Age

Datentyp

boolean

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

Postmenopausal state

Datentyp

boolean

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

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

Datentyp

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
Beschreibung

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:
Beschreibung

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

Datentyp

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
Beschreibung

Impaired cognition Mini-mental state examination

Datentyp

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;
Beschreibung

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

Datentyp

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;
Beschreibung

Radiotherapy to head | intrathecal therapy

Datentyp

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;
Beschreibung

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

Datentyp

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
Beschreibung

Cancer Other | Exception Basal cell carcinoma

Datentyp

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).
Beschreibung

Cognitive training Other

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1868940
UMLS CUI [1,2]
C0205394
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Breast Cancer NCT01497015

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video