ID

38214

Description

Examining the Relationships Between Sleep, Fatigue, and Pain in Aromatase Inhibitor-treated Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01983995

Link

https://clinicaltrials.gov/show/NCT01983995

Keywords

Versions (1)
  1. 9/28/19 9/28/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 28, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01983995

English

Eligibility Breast Cancer NCT01983995

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
female, aged 50 years or older, postmenopausal.
Description

Age | Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0232970
patients with histologically proven stage 0-iii invasive carcinoma of the breast that is estrogen receptor and/or progesterone receptor positive by immunohistochemical staining, who are planning to start treatment with a standard dose of aromatase inhibitor (ai) therapy.
Description

Invasive carcinoma of breast Estrogen receptor positive TNM Breast tumor staging Immunohistochemistry | Invasive carcinoma of breast Progesterone receptor positive TNM Breast tumor staging Immunohistochemistry | Aromatase Inhibitors Standard Dose Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0279754
UMLS CUI [1,3]
C0474926
UMLS CUI [1,4]
C0021044
UMLS CUI [2,1]
C0853879
UMLS CUI [2,2]
C0279759
UMLS CUI [2,3]
C0474926
UMLS CUI [2,4]
C0021044
UMLS CUI [3,1]
C0593802
UMLS CUI [3,2]
C1442989
UMLS CUI [3,3]
C0178602
UMLS CUI [3,4]
C1301732
subjects must have undergone surgical resection of their primary tumor, as indicated. the most recent surgery must have been performed at least 4 weeks before the baseline evaluation and no additional surgeries (including reconstructive procedures) should be planned during study participation.
Description

Primary tumor Excision | Indication Primary tumor Excision | Operative Surgical Procedures Additional Absent | Reconstructive Surgical Procedures Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0728940
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0677930
UMLS CUI [2,3]
C0728940
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C1524062
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C0524865
UMLS CUI [4,2]
C0332197
cytoxic chemotherapy, if applicable, must have been completed at least 4 weeks before the baseline evaluation.
Description

Cytotoxic Chemotherapy Completed

Data type

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C0205197
radiation therapy, if applicable, must have been completed at least 2 weeks before baseline evaluation.
Description

Therapeutic radiology procedure Completed

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0205197
eastern cooperative oncology group performance status 0-2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
ability to operate the accelerometer
Description

Ability operate Accelerometer

Data type

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C3242339
UMLS CUI [1,3]
C0178951
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
diagnosis of sleep apnea or restless leg syndrome.
Description

Sleep Apnea | Restless Legs Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0037315
UMLS CUI [2]
C0035258
use of a wheelchair for ambulation most of the time.
Description

Wheelchair Usually Used During ambulation

Data type

boolean

Alias
UMLS CUI [1,1]
C4321408
UMLS CUI [1,2]
C4302601
second or third shift workers or other non-traditional sleep schedules.
Description

Shift worker | Sleep Plan Unusual

Data type

boolean

Alias
UMLS CUI [1]
C0425104
UMLS CUI [2,1]
C0037313
UMLS CUI [2,2]
C1301732
UMLS CUI [2,3]
C2700116
history of medical arthritic disease that could confound or interfere with evaluation of pain or activity level, including but not limited to inflammatory arthritis (rheumatoid arthritis, systemic lupus, spondyloarthropathy, psoriatic arthritis, polymyalgia rheumatica), parkinson's disease, and cancer involving the bone.
Description

Arthritis Interferes with Evaluation Pain | Arthritis Interferes with Evaluation Activity level | Rheumatoid Arthritis | Lupus Erythematosus, Systemic | Spondylarthropathy | Arthritis, Psoriatic | Polymyalgia Rheumatica | Parkinson Disease | Malignant Neoplasm Involving Bone

Data type

boolean

Alias
UMLS CUI [1,1]
C0003864
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C1261322
UMLS CUI [1,4]
C0030193
UMLS CUI [2,1]
C0003864
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1261322
UMLS CUI [2,4]
C0683317
UMLS CUI [3]
C0003873
UMLS CUI [4]
C0024141
UMLS CUI [5]
C0949691
UMLS CUI [6]
C0003872
UMLS CUI [7]
C0032533
UMLS CUI [8]
C0030567
UMLS CUI [9,1]
C0006826
UMLS CUI [9,2]
C1314939
UMLS CUI [9,3]
C0262950
serious or unstable medical condition that could likely lead to hospitalization during the course of the study or compromise study participation
Description

Medical condition Serious Hospitalization Required | Medical condition Unstable Hospitalization Required | Medical condition Serious compromises Study Subject Participation Status | Medical condition Unstable compromises Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C1708385
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0443343
UMLS CUI [2,3]
C1708385
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C2945640
UMLS CUI [3,4]
C2348568
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0443343
UMLS CUI [4,3]
C2945640
UMLS CUI [4,4]
C2348568
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Similar models

Eligibility Breast Cancer NCT01983995

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Postmenopausal state
Item
female, aged 50 years or older, postmenopausal.
boolean
C0001779 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
Invasive carcinoma of breast Estrogen receptor positive TNM Breast tumor staging Immunohistochemistry | Invasive carcinoma of breast Progesterone receptor positive TNM Breast tumor staging Immunohistochemistry | Aromatase Inhibitors Standard Dose Planned
Item
patients with histologically proven stage 0-iii invasive carcinoma of the breast that is estrogen receptor and/or progesterone receptor positive by immunohistochemical staining, who are planning to start treatment with a standard dose of aromatase inhibitor (ai) therapy.
boolean
C0853879 (UMLS CUI [1,1])
C0279754 (UMLS CUI [1,2])
C0474926 (UMLS CUI [1,3])
C0021044 (UMLS CUI [1,4])
C0853879 (UMLS CUI [2,1])
C0279759 (UMLS CUI [2,2])
C0474926 (UMLS CUI [2,3])
C0021044 (UMLS CUI [2,4])
C0593802 (UMLS CUI [3,1])
C1442989 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
C1301732 (UMLS CUI [3,4])
Primary tumor Excision | Indication Primary tumor Excision | Operative Surgical Procedures Additional Absent | Reconstructive Surgical Procedures Absent
Item
subjects must have undergone surgical resection of their primary tumor, as indicated. the most recent surgery must have been performed at least 4 weeks before the baseline evaluation and no additional surgeries (including reconstructive procedures) should be planned during study participation.
boolean
C0677930 (UMLS CUI [1,1])
C0728940 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0677930 (UMLS CUI [2,2])
C0728940 (UMLS CUI [2,3])
C0543467 (UMLS CUI [3,1])
C1524062 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0524865 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Cytotoxic Chemotherapy Completed
Item
cytoxic chemotherapy, if applicable, must have been completed at least 4 weeks before the baseline evaluation.
boolean
C0677881 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Therapeutic radiology procedure Completed
Item
radiation therapy, if applicable, must have been completed at least 2 weeks before baseline evaluation.
boolean
C1522449 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
ECOG performance status
Item
eastern cooperative oncology group performance status 0-2.
boolean
C1520224 (UMLS CUI [1])
Ability operate Accelerometer
Item
ability to operate the accelerometer
boolean
C0085732 (UMLS CUI [1,1])
C3242339 (UMLS CUI [1,2])
C0178951 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Sleep Apnea | Restless Legs Syndrome
Item
diagnosis of sleep apnea or restless leg syndrome.
boolean
C0037315 (UMLS CUI [1])
C0035258 (UMLS CUI [2])
Wheelchair Usually Used During ambulation
Item
use of a wheelchair for ambulation most of the time.
boolean
C4321408 (UMLS CUI [1,1])
C4302601 (UMLS CUI [1,2])
Shift worker | Sleep Plan Unusual
Item
second or third shift workers or other non-traditional sleep schedules.
boolean
C0425104 (UMLS CUI [1])
C0037313 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C2700116 (UMLS CUI [2,3])
Arthritis Interferes with Evaluation Pain | Arthritis Interferes with Evaluation Activity level | Rheumatoid Arthritis | Lupus Erythematosus, Systemic | Spondylarthropathy | Arthritis, Psoriatic | Polymyalgia Rheumatica | Parkinson Disease | Malignant Neoplasm Involving Bone
Item
history of medical arthritic disease that could confound or interfere with evaluation of pain or activity level, including but not limited to inflammatory arthritis (rheumatoid arthritis, systemic lupus, spondyloarthropathy, psoriatic arthritis, polymyalgia rheumatica), parkinson's disease, and cancer involving the bone.
boolean
C0003864 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1261322 (UMLS CUI [1,3])
C0030193 (UMLS CUI [1,4])
C0003864 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
C0683317 (UMLS CUI [2,4])
C0003873 (UMLS CUI [3])
C0024141 (UMLS CUI [4])
C0949691 (UMLS CUI [5])
C0003872 (UMLS CUI [6])
C0032533 (UMLS CUI [7])
C0030567 (UMLS CUI [8])
C0006826 (UMLS CUI [9,1])
C1314939 (UMLS CUI [9,2])
C0262950 (UMLS CUI [9,3])
Medical condition Serious Hospitalization Required | Medical condition Unstable Hospitalization Required | Medical condition Serious compromises Study Subject Participation Status | Medical condition Unstable compromises Study Subject Participation Status
Item
serious or unstable medical condition that could likely lead to hospitalization during the course of the study or compromise study participation
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1708385 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C1708385 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C2945640 (UMLS CUI [3,3])
C2348568 (UMLS CUI [3,4])
C3843040 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C2945640 (UMLS CUI [4,3])
C2348568 (UMLS CUI [4,4])
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