ID

38217

Beschrijving

Moving Forward: A Weight Loss Intervention for African-American Breast Cancer Survivors; ODM derived from: https://clinicaltrials.gov/show/NCT02482506

Link

https://clinicaltrials.gov/show/NCT02482506

Trefwoorden

  1. 28-09-19 28-09-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

28 september 2019

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT02482506

Eligibility Breast Cancer NCT02482506

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
self-identification as black or african american (including individuals who are bi-racial but identify themselves as black or aa)
Beschrijving

Black | African American

Datatype

boolean

Alias
UMLS CUI [1]
C0005680
UMLS CUI [2]
C0085756
female
Beschrijving

Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
stage i, ii, and iii invasive breast carcinoma
Beschrijving

Invasive carcinoma of breast TNM Breast tumor staging

Datatype

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0474926
treatment (surgery, chemotherapy and/or radiation) completed at least 6 months prior to recruitment (ongoing treatment with tamoxifen or ais is acceptable)
Beschrijving

Treatment completed | Operative Surgical Procedures | Chemotherapy | Therapeutic radiology procedure | Tamoxifen Continuous | Aromatase Inhibitors Continuous |

Datatype

boolean

Alias
UMLS CUI [1]
C0580352
UMLS CUI [2]
C0543467
UMLS CUI [3]
C0392920
UMLS CUI [4]
C1522449
UMLS CUI [5,1]
C0039286
UMLS CUI [5,2]
C0549178
UMLS CUI [6,1]
C0593802
UMLS CUI [6,2]
C0549178
age 18 or above at time of diagnosis
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
bmi at least 25 km/m2
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
physically able to participate in a moderate physical activity program as assessed by a screening questionnaire and pcp approval.
Beschrijving

Participation Moderate physical activity Program | Assessment Screening questionnaire

Datatype

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C4482418
UMLS CUI [1,3]
C3484370
UMLS CUI [2,1]
C1516048
UMLS CUI [2,2]
C1134635
agreeable to random assignment and data collection including blood draw.
Beschrijving

Random assignment | Data Collection | Blood draw

Datatype

boolean

Alias
UMLS CUI [1]
C0814868
UMLS CUI [2]
C0010995
UMLS CUI [3]
C0005834
able to attend twic weekly classes for 6 months.
Beschrijving

Other Coding

Datatype

boolean

Alias
UMLS CUI [1]
C3846158
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
plans to move from the community during the study
Beschrijving

Relocation of home Planned

Datatype

boolean

Alias
UMLS CUI [1,1]
C2699029
UMLS CUI [1,2]
C1301732
medical condition limiting adherence as assessed by pcp
Beschrijving

Medical condition Limiting Adherence

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C1510802
history of significant mental illness
Beschrijving

Mental disorder

Datatype

boolean

Alias
UMLS CUI [1]
C0004936
currently pregnant, less than 3 months post-partum, or pregnancy anticipated during the study..
Beschrijving

Pregnancy | Postpartum Period | Pregnancy, Planned

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0086839
UMLS CUI [3]
C0032992
current/planned use of an fda-approved or over the counter weight loss medication.
Beschrijving

Weight-Loss Agents | Non-Prescription Weight-Loss Agents

Datatype

boolean

Alias
UMLS CUI [1]
C0376606
UMLS CUI [2,1]
C0013231
UMLS CUI [2,2]
C0376606
participation in another structured weight loss program
Beschrijving

Participation Weight Reduction Program

Datatype

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C3179079

Similar models

Eligibility Breast Cancer NCT02482506

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Black | African American
Item
self-identification as black or african american (including individuals who are bi-racial but identify themselves as black or aa)
boolean
C0005680 (UMLS CUI [1])
C0085756 (UMLS CUI [2])
Gender
Item
female
boolean
C0079399 (UMLS CUI [1])
Invasive carcinoma of breast TNM Breast tumor staging
Item
stage i, ii, and iii invasive breast carcinoma
boolean
C0853879 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Treatment completed | Operative Surgical Procedures | Chemotherapy | Therapeutic radiology procedure | Tamoxifen Continuous | Aromatase Inhibitors Continuous |
Item
treatment (surgery, chemotherapy and/or radiation) completed at least 6 months prior to recruitment (ongoing treatment with tamoxifen or ais is acceptable)
boolean
C0580352 (UMLS CUI [1])
C0543467 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
C0039286 (UMLS CUI [5,1])
C0549178 (UMLS CUI [5,2])
C0593802 (UMLS CUI [6,1])
C0549178 (UMLS CUI [6,2])
Age
Item
age 18 or above at time of diagnosis
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
bmi at least 25 km/m2
boolean
C1305855 (UMLS CUI [1])
Participation Moderate physical activity Program | Assessment Screening questionnaire
Item
physically able to participate in a moderate physical activity program as assessed by a screening questionnaire and pcp approval.
boolean
C0679823 (UMLS CUI [1,1])
C4482418 (UMLS CUI [1,2])
C3484370 (UMLS CUI [1,3])
C1516048 (UMLS CUI [2,1])
C1134635 (UMLS CUI [2,2])
Random assignment | Data Collection | Blood draw
Item
agreeable to random assignment and data collection including blood draw.
boolean
C0814868 (UMLS CUI [1])
C0010995 (UMLS CUI [2])
C0005834 (UMLS CUI [3])
Other Coding
Item
able to attend twic weekly classes for 6 months.
boolean
C3846158 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Relocation of home Planned
Item
plans to move from the community during the study
boolean
C2699029 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Medical condition Limiting Adherence
Item
medical condition limiting adherence as assessed by pcp
boolean
C3843040 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C1510802 (UMLS CUI [1,3])
Mental disorder
Item
history of significant mental illness
boolean
C0004936 (UMLS CUI [1])
Pregnancy | Postpartum Period | Pregnancy, Planned
Item
currently pregnant, less than 3 months post-partum, or pregnancy anticipated during the study..
boolean
C0032961 (UMLS CUI [1])
C0086839 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Weight-Loss Agents | Non-Prescription Weight-Loss Agents
Item
current/planned use of an fda-approved or over the counter weight loss medication.
boolean
C0376606 (UMLS CUI [1])
C0013231 (UMLS CUI [2,1])
C0376606 (UMLS CUI [2,2])
Participation Weight Reduction Program
Item
participation in another structured weight loss program
boolean
C0679823 (UMLS CUI [1,1])
C3179079 (UMLS CUI [1,2])

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