ID

34962

Beschreibung

Behavioral Weight Loss and Exercise After Treatment (BEAT); ODM derived from: https://clinicaltrials.gov/show/NCT02052115

Link

https://clinicaltrials.gov/show/NCT02052115

Stichworte

Versionen (1)
  1. 05.02.19 05.02.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

5. Februar 2019

DOI

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Eligibility Breast Cancer NCT02052115

Englisch

Eligibility Breast Cancer NCT02052115

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
breast cancer diagnosis
Beschreibung

Breast Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0678222
received surgery +/- chemotherapy +/- radiation for treatment of a stage i, ii or iii breast cancer. ongoing treatment with monoclonal antibodies and/or anti-estrogen therapy is acceptable
Beschreibung

Operative Surgical Procedures Breast Carcinoma TNM Breast tumor staging | Chemotherapy Breast Carcinoma TNM Breast tumor staging | Therapeutic radiology procedure Breast Carcinoma TNM Breast tumor staging | Monoclonal Antibody Therapy Acceptable | Antioestrogen therapy Acceptable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0678222
UMLS CUI [1,3]
C0474926
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0678222
UMLS CUI [2,3]
C0474926
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0678222
UMLS CUI [3,3]
C0474926
UMLS CUI [4,1]
C0279694
UMLS CUI [4,2]
C1879533
UMLS CUI [5,1]
C0854638
UMLS CUI [5,2]
C1879533
completion of initial therapy 6 weeks prior to study initiation
Beschreibung

Therapy Initial Completion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205265
UMLS CUI [1,3]
C0205197
bmi of 27-45 kg/m^2
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior diagnosis of malignancy other than non-melanoma skin cancer (i.e. prior non-melanoma skin cancer is not an exclusion criteria)
Beschreibung

Malignant Neoplasm Previous | Exception Skin carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
medical conditions that limit food choices such as celiac sprue or inflammatory bowel disease
Beschreibung

Medical condition Limiting Food Choice | Celiac Disease | Inflammatory Bowel Disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0016452
UMLS CUI [1,4]
C1707391
UMLS CUI [2]
C0007570
UMLS CUI [3]
C0021390
inability to walk on flat ground (or a treadmill) at 2.5 mph for 5 minutes
Beschreibung

Lacking Able to walk on the flat Duration | Lacking Able to walk Treadmill Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0560049
UMLS CUI [1,3]
C0449238
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C2712089
UMLS CUI [2,3]
C0184069
UMLS CUI [2,4]
C0449238
age <21 and >70
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
presence of body metal
Beschreibung

Metal Body Present

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0025552
UMLS CUI [1,2]
C0460148
UMLS CUI [1,3]
C0150312
psychotic or central nervous system impairment that would limit compliance with study requirements, including dementia
Beschreibung

Psychotic Disorder Limiting Protocol Compliance | Neurological impairment Limiting Protocol Compliance | Dementia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0033975
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0521654
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C0525058
UMLS CUI [3]
C0497327
evidence of metastatic disease
Beschreibung

Neoplasm Metastasis

Datentyp

boolean

Alias
UMLS CUI [1]
C0027627
symptomatic heart disease (chest pain or equivalent with activity)
Beschreibung

Heart Disease Symptomatic | Chest Pain caused by Physical activity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0008031
UMLS CUI [2,2]
C0015127
UMLS CUI [2,3]
C0026606
exercise limiting pulmonary disease or need for oxygen to exercise
Beschreibung

Lung disease Limiting Exercise | Requires oxygen therapy during exercise

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0015259
UMLS CUI [2]
C3840225
individuals taking mood stabilizing medications including: lithium, valproic acid, also called divalproex sodium (depakote), carbamazepine (tegretol), lamotrigine (lamictal), oxcarbazepine (trileptal), olanzapine (zyprexa), aripiprazole (abilify), risperidone (risperdal), ziprasidone (geodon), clozapine (clorazil)
Beschreibung

Mood Stabilizer | Lithium | Valproic Acid | Divalproex Sodium | Depakote | Carbamazepine | Tegretol | lamotrigine | Lamictal | oxcarbazepine | Trileptal | olanzapine | Zyprexa | aripiprazole | Abilify | Risperidone | Risperdal | ziprasidone | Geodon | Clozapine

Datentyp

boolean

Alias
UMLS CUI [1]
C2917435
UMLS CUI [2]
C0023870
UMLS CUI [3]
C0042291
UMLS CUI [4]
C0886883
UMLS CUI [5]
C0719751
UMLS CUI [6]
C0006949
UMLS CUI [7]
C0700087
UMLS CUI [8]
C0064636
UMLS CUI [9]
C0678180
UMLS CUI [10]
C0069751
UMLS CUI [11]
C0876196
UMLS CUI [12]
C0171023
UMLS CUI [13]
C0527258
UMLS CUI [14]
C0299792
UMLS CUI [15]
C1170019
UMLS CUI [16]
C0073393
UMLS CUI [17]
C0592071
UMLS CUI [18]
C0380393
UMLS CUI [19]
C0939698
UMLS CUI [20]
C0009079
participants with an active neurologic disorder that affects the central nervous system, including seizures, and parkinson's disease
Beschreibung

Nervous system disorder Affecting Central Nervous System | Seizures | Parkinson Disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C3714787
UMLS CUI [2]
C0036572
UMLS CUI [3]
C0030567
weight loss of >10 lbs in the previous 6 months
Beschreibung

Weight decreased Amount Timespan

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0872291
participation in > 150 minutes of moderate intensity activity by self report, unless activity level by accelerometer is less than 150 minutes of moderate intensity activity
Beschreibung

Participation Physical activity Moderate intensity Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0026606
UMLS CUI [1,3]
C4081855
UMLS CUI [1,4]
C0449238
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Ähnliche Modelle

Eligibility Breast Cancer NCT02052115

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma
Item
breast cancer diagnosis
boolean
C0678222 (UMLS CUI [1])
Operative Surgical Procedures Breast Carcinoma TNM Breast tumor staging | Chemotherapy Breast Carcinoma TNM Breast tumor staging | Therapeutic radiology procedure Breast Carcinoma TNM Breast tumor staging | Monoclonal Antibody Therapy Acceptable | Antioestrogen therapy Acceptable
Item
received surgery +/- chemotherapy +/- radiation for treatment of a stage i, ii or iii breast cancer. ongoing treatment with monoclonal antibodies and/or anti-estrogen therapy is acceptable
boolean
C0543467 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0474926 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C0474926 (UMLS CUI [2,3])
C1522449 (UMLS CUI [3,1])
C0678222 (UMLS CUI [3,2])
C0474926 (UMLS CUI [3,3])
C0279694 (UMLS CUI [4,1])
C1879533 (UMLS CUI [4,2])
C0854638 (UMLS CUI [5,1])
C1879533 (UMLS CUI [5,2])
Therapy Initial Completion
Item
completion of initial therapy 6 weeks prior to study initiation
boolean
C0087111 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Body mass index
Item
bmi of 27-45 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasm Previous | Exception Skin carcinoma
Item
prior diagnosis of malignancy other than non-melanoma skin cancer (i.e. prior non-melanoma skin cancer is not an exclusion criteria)
boolean
C0006826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
Medical condition Limiting Food Choice | Celiac Disease | Inflammatory Bowel Disease
Item
medical conditions that limit food choices such as celiac sprue or inflammatory bowel disease
boolean
C3843040 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0016452 (UMLS CUI [1,3])
C1707391 (UMLS CUI [1,4])
C0007570 (UMLS CUI [2])
C0021390 (UMLS CUI [3])
Lacking Able to walk on the flat Duration | Lacking Able to walk Treadmill Duration
Item
inability to walk on flat ground (or a treadmill) at 2.5 mph for 5 minutes
boolean
C0332268 (UMLS CUI [1,1])
C0560049 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C0332268 (UMLS CUI [2,1])
C2712089 (UMLS CUI [2,2])
C0184069 (UMLS CUI [2,3])
C0449238 (UMLS CUI [2,4])
Age
Item
age <21 and >70
boolean
C0001779 (UMLS CUI [1])
Metal Body Present
Item
presence of body metal
boolean
C0025552 (UMLS CUI [1,1])
C0460148 (UMLS CUI [1,2])
C0150312 (UMLS CUI [1,3])
Psychotic Disorder Limiting Protocol Compliance | Neurological impairment Limiting Protocol Compliance | Dementia
Item
psychotic or central nervous system impairment that would limit compliance with study requirements, including dementia
boolean
C0033975 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0521654 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0497327 (UMLS CUI [3])
Neoplasm Metastasis
Item
evidence of metastatic disease
boolean
C0027627 (UMLS CUI [1])
Heart Disease Symptomatic | Chest Pain caused by Physical activity
Item
symptomatic heart disease (chest pain or equivalent with activity)
boolean
C0018799 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0008031 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C0026606 (UMLS CUI [2,3])
Lung disease Limiting Exercise | Requires oxygen therapy during exercise
Item
exercise limiting pulmonary disease or need for oxygen to exercise
boolean
C0024115 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0015259 (UMLS CUI [1,3])
C3840225 (UMLS CUI [2])
Mood Stabilizer | Lithium | Valproic Acid | Divalproex Sodium | Depakote | Carbamazepine | Tegretol | lamotrigine | Lamictal | oxcarbazepine | Trileptal | olanzapine | Zyprexa | aripiprazole | Abilify | Risperidone | Risperdal | ziprasidone | Geodon | Clozapine
Item
individuals taking mood stabilizing medications including: lithium, valproic acid, also called divalproex sodium (depakote), carbamazepine (tegretol), lamotrigine (lamictal), oxcarbazepine (trileptal), olanzapine (zyprexa), aripiprazole (abilify), risperidone (risperdal), ziprasidone (geodon), clozapine (clorazil)
boolean
C2917435 (UMLS CUI [1])
C0023870 (UMLS CUI [2])
C0042291 (UMLS CUI [3])
C0886883 (UMLS CUI [4])
C0719751 (UMLS CUI [5])
C0006949 (UMLS CUI [6])
C0700087 (UMLS CUI [7])
C0064636 (UMLS CUI [8])
C0678180 (UMLS CUI [9])
C0069751 (UMLS CUI [10])
C0876196 (UMLS CUI [11])
C0171023 (UMLS CUI [12])
C0527258 (UMLS CUI [13])
C0299792 (UMLS CUI [14])
C1170019 (UMLS CUI [15])
C0073393 (UMLS CUI [16])
C0592071 (UMLS CUI [17])
C0380393 (UMLS CUI [18])
C0939698 (UMLS CUI [19])
C0009079 (UMLS CUI [20])
Nervous system disorder Affecting Central Nervous System | Seizures | Parkinson Disease
Item
participants with an active neurologic disorder that affects the central nervous system, including seizures, and parkinson's disease
boolean
C0027765 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C3714787 (UMLS CUI [1,3])
C0036572 (UMLS CUI [2])
C0030567 (UMLS CUI [3])
Weight decreased Amount Timespan
Item
weight loss of >10 lbs in the previous 6 months
boolean
C1262477 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0872291 (UMLS CUI [1,3])
Participation Physical activity Moderate intensity Duration
Item
participation in > 150 minutes of moderate intensity activity by self report, unless activity level by accelerometer is less than 150 minutes of moderate intensity activity
boolean
C0679823 (UMLS CUI [1,1])
C0026606 (UMLS CUI [1,2])
C4081855 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,4])
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