ID

37840

Description

Reducing Breast Cancer Recurrence With Weight Loss; ODM derived from: https://clinicaltrials.gov/show/NCT01112839

Link

https://clinicaltrials.gov/show/NCT01112839

Keywords

Versions (1)
  1. 8/27/19 8/27/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 27, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01112839

English

Eligibility Breast Cancer NCT01112839

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of breast cancer (stages i (≥1 cm), stage ii, or stage iiia, b, c excluding distant metastasis) diagnosed between 6 months and 5 years earlier; after initial therapies are completed, diagnosed between six months and five years earlier
Description

Breast Carcinoma TNM Breast tumor staging | Distant metastasis Excluded | Disease length | Therapeutic procedure Initial Completed

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0474926
UMLS CUI [2,1]
C1269798
UMLS CUI [2,2]
C0332196
UMLS CUI [3]
C0872146
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0205265
UMLS CUI [4,3]
C0205197
bmi between 25 to 45 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
able to comply with all required study procedures and schedule
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
serious medical condition or psychiatric illness
Description

Medical condition Serious | Mental disorders Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205404
inability to be moderately physically active
Description

Moderate physical activity Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C4482418
UMLS CUI [1,2]
C1299582
obesity of known endocrine origin (e.g., untreated hypothyroidism, pcos)
Description

Obesity of endocrine origin | Hypothyroidism Untreated | PCOS

Data type

boolean

Alias
UMLS CUI [1]
C0267992
UMLS CUI [2,1]
C0020676
UMLS CUI [2,2]
C0332155
UMLS CUI [3]
C0032460
currently enrolled in a weight loss program
Description

Enrollment Weight Reduction Program

Data type

boolean

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C3179079
current use of weight loss medication or supplements
Description

Weight-Loss Agents | Weight loss Supplements

Data type

boolean

Alias
UMLS CUI [1]
C0376606
UMLS CUI [2,1]
C1262477
UMLS CUI [2,2]
C0242295
previous surgical procedures for weight reduction
Description

Bariatric Surgery Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C1456587
UMLS CUI [1,2]
C0205156
planning weight loss surgery in the next 2 years.
Description

Bariatric Surgery Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C1456587
UMLS CUI [1,2]
C1301732
6+ months use of meds likely to cause weight gain or prevent weight loss
Description

Pharmaceutical Preparations Causing Weight Gain | Pharmaceutical Preparations Preventing Weight loss

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0043094
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C1262477
planned surgical procedure that can impact the conduct of the study
Description

Operative Surgical Procedure Planned | Impact Possible Completion of clinical trial

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C4049986
UMLS CUI [2,2]
C0332149
UMLS CUI [2,3]
C2732579
currently pregnant/breastfeeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
planning to become pregnant within the next 2 years
Description

Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032992
have plans to relocate from area within 2 years
Description

Relocation of home Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C2699029
UMLS CUI [1,2]
C1301732
family relative or close friend is a trial staff member or a study participant
Description

Relative Clinical Trial Staff Member | Close friend Clinical Trial Staff Member | Relative Study Subject | Close friend Study Subject

Data type

boolean

Alias
UMLS CUI [1,1]
C0080103
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C1552089
UMLS CUI [2,1]
C0682339
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C1552089
UMLS CUI [3,1]
C0080103
UMLS CUI [3,2]
C0681850
UMLS CUI [4,1]
C0682339
UMLS CUI [4,2]
C0681850
any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in this study
Description

Condition Study Subject Participation Status Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1548788
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Similar models

Eligibility Breast Cancer NCT01112839

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma TNM Breast tumor staging | Distant metastasis Excluded | Disease length | Therapeutic procedure Initial Completed
Item
diagnosis of breast cancer (stages i (≥1 cm), stage ii, or stage iiia, b, c excluding distant metastasis) diagnosed between 6 months and 5 years earlier; after initial therapies are completed, diagnosed between six months and five years earlier
boolean
C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C1269798 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0872146 (UMLS CUI [3])
C0087111 (UMLS CUI [4,1])
C0205265 (UMLS CUI [4,2])
C0205197 (UMLS CUI [4,3])
Body mass index
Item
bmi between 25 to 45 kg/m2
boolean
C1305855 (UMLS CUI [1])
Protocol Compliance
Item
able to comply with all required study procedures and schedule
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Medical condition Serious | Mental disorders Serious
Item
serious medical condition or psychiatric illness
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Moderate physical activity Unable
Item
inability to be moderately physically active
boolean
C4482418 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Obesity of endocrine origin | Hypothyroidism Untreated | PCOS
Item
obesity of known endocrine origin (e.g., untreated hypothyroidism, pcos)
boolean
C0267992 (UMLS CUI [1])
C0020676 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0032460 (UMLS CUI [3])
Enrollment Weight Reduction Program
Item
currently enrolled in a weight loss program
boolean
C1516879 (UMLS CUI [1,1])
C3179079 (UMLS CUI [1,2])
Weight-Loss Agents | Weight loss Supplements
Item
current use of weight loss medication or supplements
boolean
C0376606 (UMLS CUI [1])
C1262477 (UMLS CUI [2,1])
C0242295 (UMLS CUI [2,2])
Bariatric Surgery Previous
Item
previous surgical procedures for weight reduction
boolean
C1456587 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Bariatric Surgery Planned
Item
planning weight loss surgery in the next 2 years.
boolean
C1456587 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Pharmaceutical Preparations Causing Weight Gain | Pharmaceutical Preparations Preventing Weight loss
Item
6+ months use of meds likely to cause weight gain or prevent weight loss
boolean
C0013227 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0043094 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C1262477 (UMLS CUI [2,3])
Operative Surgical Procedure Planned | Impact Possible Completion of clinical trial
Item
planned surgical procedure that can impact the conduct of the study
boolean
C0543467 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C4049986 (UMLS CUI [2,1])
C0332149 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
currently pregnant/breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Pregnancy, Planned
Item
planning to become pregnant within the next 2 years
boolean
C0032992 (UMLS CUI [1])
Relocation of home Planned
Item
have plans to relocate from area within 2 years
boolean
C2699029 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Relative Clinical Trial Staff Member | Close friend Clinical Trial Staff Member | Relative Study Subject | Close friend Study Subject
Item
family relative or close friend is a trial staff member or a study participant
boolean
C0080103 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C1552089 (UMLS CUI [1,3])
C0682339 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C1552089 (UMLS CUI [2,3])
C0080103 (UMLS CUI [3,1])
C0681850 (UMLS CUI [3,2])
C0682339 (UMLS CUI [4,1])
C0681850 (UMLS CUI [4,2])
Condition Study Subject Participation Status Inappropriate
Item
any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in this study
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
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