ID

37994

Description

Factors Influencing Decision-Making About the Use of Chemoprevention in Women at Increased Risk for Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01399359

Link

https://clinicaltrials.gov/show/NCT01399359

Keywords

Versions (1)
  1. 9/5/19 9/5/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 5, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01399359

English

Eligibility Breast Cancer NCT01399359

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
the participant must be female.
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
the participant must be greater than or equal to 35 years of age.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
the participant must be english-speaking.
Description

Able to speak English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
the participant must have been identified as being at increased risk for breast cancer as determined by the doctor/healthcare professional (hcp) . (increased risk for breast cancer does not have to be based on a gail score.)
Description

At risk Increased Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1444641
UMLS CUI [1,2]
C0205217
UMLS CUI [1,3]
C0678222
during the participant's counseling session, breast cancer risk and the use of serms for breast cancer risk reduction must have been discussed, as reported by the doctor/hcp who conducted the session. note: this criterion does not apply to participants who are asked before the counseling session to participate in the video recording component of dmp-1 at the selected nsabp sites.
Description

Specific patient counseling session | Discussion | Risk Breast Carcinoma | SERMs Risk Reduction Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0199393
UMLS CUI [2]
C0557061
UMLS CUI [3,1]
C0035647
UMLS CUI [3,2]
C0678222
UMLS CUI [4,1]
C0732611
UMLS CUI [4,2]
C1137094
UMLS CUI [4,3]
C0678222
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous invasive breast cancer of any type.
Description

Invasive carcinoma of breast Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0205156
previous history of ductal carcinoma in situ (dcis).
Description

DCIS Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0007124
UMLS CUI [1,2]
C0205156
previous history of lobular carcinoma in situ (lcis) if treated with mastectomy, radiation therapy, or endocrine therapy.
Description

Lobular carcinoma in situ of breast Previous | Mastectomy | Therapeutic radiology procedure | Hormone Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0279563
UMLS CUI [1,2]
C0205156
UMLS CUI [2]
C0024881
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0279025
participation in any other cancer prevention study involving pharmacologic intervention(s) or osteoporosis prevention study involving pharmacologic intervention(s).
Description

Study Subject Participation Status | Cancer prevention | Intervention pharmacological | Prevention of osteoporosis

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0281206
UMLS CUI [3,1]
C0184661
UMLS CUI [3,2]
C0205464
UMLS CUI [4]
C3650929
any history of or current tamoxifen, raloxifene, or other serm therapy for any reason. (participants are eligible if serm use has been discussed prior to the counseling session as long as serms were never used.)
Description

Tamoxifen | Raloxifene | Selective Estrogen Receptor Modulators

Data type

boolean

Alias
UMLS CUI [1]
C0039286
UMLS CUI [2]
C0244404
UMLS CUI [3]
C0732611
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Similar models

Eligibility Breast Cancer NCT01399359

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
the participant must be female.
boolean
C0079399 (UMLS CUI [1])
Age
Item
the participant must be greater than or equal to 35 years of age.
boolean
C0001779 (UMLS CUI [1])
Able to speak English Language
Item
the participant must be english-speaking.
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
At risk Increased Breast Carcinoma
Item
the participant must have been identified as being at increased risk for breast cancer as determined by the doctor/healthcare professional (hcp) . (increased risk for breast cancer does not have to be based on a gail score.)
boolean
C1444641 (UMLS CUI [1,1])
C0205217 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
Specific patient counseling session | Discussion | Risk Breast Carcinoma | SERMs Risk Reduction Breast Carcinoma
Item
during the participant's counseling session, breast cancer risk and the use of serms for breast cancer risk reduction must have been discussed, as reported by the doctor/hcp who conducted the session. note: this criterion does not apply to participants who are asked before the counseling session to participate in the video recording component of dmp-1 at the selected nsabp sites.
boolean
C0199393 (UMLS CUI [1])
C0557061 (UMLS CUI [2])
C0035647 (UMLS CUI [3,1])
C0678222 (UMLS CUI [3,2])
C0732611 (UMLS CUI [4,1])
C1137094 (UMLS CUI [4,2])
C0678222 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Invasive carcinoma of breast Previous
Item
previous invasive breast cancer of any type.
boolean
C0853879 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
DCIS Previous
Item
previous history of ductal carcinoma in situ (dcis).
boolean
C0007124 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Lobular carcinoma in situ of breast Previous | Mastectomy | Therapeutic radiology procedure | Hormone Therapy
Item
previous history of lobular carcinoma in situ (lcis) if treated with mastectomy, radiation therapy, or endocrine therapy.
boolean
C0279563 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0024881 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0279025 (UMLS CUI [4])
Study Subject Participation Status | Cancer prevention | Intervention pharmacological | Prevention of osteoporosis
Item
participation in any other cancer prevention study involving pharmacologic intervention(s) or osteoporosis prevention study involving pharmacologic intervention(s).
boolean
C2348568 (UMLS CUI [1])
C0281206 (UMLS CUI [2])
C0184661 (UMLS CUI [3,1])
C0205464 (UMLS CUI [3,2])
C3650929 (UMLS CUI [4])
Tamoxifen | Raloxifene | Selective Estrogen Receptor Modulators
Item
any history of or current tamoxifen, raloxifene, or other serm therapy for any reason. (participants are eligible if serm use has been discussed prior to the counseling session as long as serms were never used.)
boolean
C0039286 (UMLS CUI [1])
C0244404 (UMLS CUI [2])
C0732611 (UMLS CUI [3])
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