ID

26090

Beschreibung

DAMES: Daughters And MothErS Against Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00630591

Link

https://clinicaltrials.gov/show/NCT00630591

Stichworte

Versionen (1)
  1. 09.10.17 09.10.17 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

9. Oktober 2017

DOI

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Eligibility Breast Cancer NCT00630591

Englisch

Eligibility Breast Cancer NCT00630591

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. dcis or stage i-iiia breast cancer (mothers)
Beschreibung

Noninfiltrating Intraductal Carcinoma | Breast Carcinoma TNM Breast tumor staging | Mother

Datentyp

boolean

Alias
UMLS CUI [1]
C0007124
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0474926
UMLS CUI [3]
C0026591
2. have a biological daughter at least 21 years old (mothers)
Beschreibung

Biological daughter | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0337552
UMLS CUI [2]
C0001779
3. body mass index between 25 - 40 (mothers) or 25 or above (daughters)
Beschreibung

Body mass index | Mother | Daughter

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0026591
UMLS CUI [3]
C0337552
4. english speaking & writing (mothers & daughters)
Beschreibung

Able to speak English Language | Able to write English Language | Mother | Daughter

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0584993
UMLS CUI [2,2]
C0376245
UMLS CUI [3]
C0026591
UMLS CUI [4]
C0337552
5. 5th grade or higher educational level (mothers & daughters)
Beschreibung

Educational Status Grade | Mother | Daughter

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013658
UMLS CUI [1,2]
C0441800
UMLS CUI [2]
C0026591
UMLS CUI [3]
C0337552
6. willingness to be randomized into the standardized or tailored intervention arms and to undergo baseline and follow-up assessments (mothers & daughters)
Beschreibung

Randomization Willing | Baseline Assessment Willing | Follow-up Assessment Willing | Mother | Daughter

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0600109
UMLS CUI [2,1]
C1442488
UMLS CUI [2,2]
C1516048
UMLS CUI [2,3]
C0600109
UMLS CUI [3,1]
C3274571
UMLS CUI [3,2]
C1516048
UMLS CUI [3,3]
C0600109
UMLS CUI [4]
C0026591
UMLS CUI [5]
C0337552
7. must be at least 21 years of age (mothers & daughters)
Beschreibung

Age | Mother | Daughter

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0026591
UMLS CUI [3]
C0337552
8. must reside within the united states, puerto rico or guam and therefore able to participate in home visits made by examination management services, inc. (mothers &
Beschreibung

Residence | Home visit Participation Ability | Mother | Daughter

Datentyp

boolean

Alias
UMLS CUI [1]
C0237096
UMLS CUI [2,1]
C0020043
UMLS CUI [2,2]
C0679823
UMLS CUI [2,3]
C0085732
UMLS CUI [3]
C0026591
UMLS CUI [4]
C0337552
daughters)
Beschreibung

ID.9

Datentyp

boolean

Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. evidence of progressive breast cancer or 2nd primaries (mothers)
Beschreibung

Breast Carcinoma Progressive | Breast Carcinoma primary second | Mother

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205329
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0205225
UMLS CUI [2,3]
C0205436
UMLS CUI [3]
C0026591
2. pre-existing medical condition(s) that preclude adherence to an unsupervised exercise program or to a diet high in fruits and vegetables, such as the following: untreated stage 3 hypertension; severe orthopedic conditions; scheduled for a hip or knee replacement within 6 months; paralysis; end-stage renal disease; dementia; unstable angina; heart attack, congestive heart failure or pulmonary conditions that have required hospitalization or oxygen within 6 months (mothers & daughters)
Beschreibung

Medical condition Pre-existing Excludes Exercise Program | Medical condition Pre-existing Excludes Diet therapy | Hypertensive disease Stage untreated | Orthopedic problem Severe | Hip Replacement Scheduled | Knee Replacement Scheduled | Paralysis | Kidney Failure, Chronic | Dementia | Angina, Unstable | Myocardial Infarction | Congestive heart failure | Lung disease Hospitalization Required | Lung disease Requirement Oxygen | Mother | Daughter

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2347662
UMLS CUI [1,3]
C0332196
UMLS CUI [1,4]
C0015259
UMLS CUI [1,5]
C3484370
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C2347662
UMLS CUI [2,3]
C0332196
UMLS CUI [2,4]
C0012159
UMLS CUI [3,1]
C0020538
UMLS CUI [3,2]
C1306673
UMLS CUI [3,3]
C0332155
UMLS CUI [4,1]
C0029354
UMLS CUI [4,2]
C0205082
UMLS CUI [5,1]
C0392806
UMLS CUI [5,2]
C0205539
UMLS CUI [6,1]
C0086511
UMLS CUI [6,2]
C0205539
UMLS CUI [7]
C0522224
UMLS CUI [8]
C0022661
UMLS CUI [9]
C0497327
UMLS CUI [10]
C0002965
UMLS CUI [11]
C0027051
UMLS CUI [12]
C0018802
UMLS CUI [13,1]
C0024115
UMLS CUI [13,2]
C1708385
UMLS CUI [14,1]
C0024115
UMLS CUI [14,2]
C1514873
UMLS CUI [14,3]
C0030054
UMLS CUI [15]
C0026591
UMLS CUI [16]
C0337552
3. currently exercising 30+ minutes/day for 5+ days/week (<150 minutes per week) (mothers & daughters)
Beschreibung

Exercise Duration Frequency | Mother | Daughter

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015259
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C0439603
UMLS CUI [2]
C0026591
UMLS CUI [3]
C0337552
4. currently enrolled in a weight loss program (mothers & daughters)
Beschreibung

Enrollment Weight Reduction Program | Mother | Daughter

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C3179079
UMLS CUI [2]
C0026591
UMLS CUI [3]
C0337552
5. residing in institutionalized settings, e.g., living in assisted or skilled nursing facilities, and therefore not able to make independent choices about their lifestyle behaviors and participate fully in the intervention (mothers and daughters).
Beschreibung

Residence Institutionalized | Assisted Living Facilities | Skilled nursing facility | Mother | Daughter

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0237096
UMLS CUI [1,2]
C0562359
UMLS CUI [2]
C0872103
UMLS CUI [3]
C0037265
UMLS CUI [4]
C0026591
UMLS CUI [5]
C0337552
6. currently pregnant (mothers & daughters)
Beschreibung

Pregnancy | Mother | Daughter

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0026591
UMLS CUI [3]
C0337552
7. a previous diagnosis of breast cancer (daughters).
Beschreibung

Prior diagnosis Breast Carcinoma | Daughter

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332132
UMLS CUI [1,2]
C0678222
UMLS CUI [2]
C0337552
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Ähnliche Modelle

Eligibility Breast Cancer NCT00630591

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Noninfiltrating Intraductal Carcinoma | Breast Carcinoma TNM Breast tumor staging | Mother
Item
1. dcis or stage i-iiia breast cancer (mothers)
boolean
C0007124 (UMLS CUI [1])
C0678222 (UMLS CUI [2,1])
C0474926 (UMLS CUI [2,2])
C0026591 (UMLS CUI [3])
Biological daughter | Age
Item
2. have a biological daughter at least 21 years old (mothers)
boolean
C0337552 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Body mass index | Mother | Daughter
Item
3. body mass index between 25 - 40 (mothers) or 25 or above (daughters)
boolean
C1305855 (UMLS CUI [1])
C0026591 (UMLS CUI [2])
C0337552 (UMLS CUI [3])
Able to speak English Language | Able to write English Language | Mother | Daughter
Item
4. english speaking & writing (mothers & daughters)
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0584993 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
C0026591 (UMLS CUI [3])
C0337552 (UMLS CUI [4])
Educational Status Grade | Mother | Daughter
Item
5. 5th grade or higher educational level (mothers & daughters)
boolean
C0013658 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0026591 (UMLS CUI [2])
C0337552 (UMLS CUI [3])
Randomization Willing | Baseline Assessment Willing | Follow-up Assessment Willing | Mother | Daughter
Item
6. willingness to be randomized into the standardized or tailored intervention arms and to undergo baseline and follow-up assessments (mothers & daughters)
boolean
C0034656 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C1442488 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
C3274571 (UMLS CUI [3,1])
C1516048 (UMLS CUI [3,2])
C0600109 (UMLS CUI [3,3])
C0026591 (UMLS CUI [4])
C0337552 (UMLS CUI [5])
Age | Mother | Daughter
Item
7. must be at least 21 years of age (mothers & daughters)
boolean
C0001779 (UMLS CUI [1])
C0026591 (UMLS CUI [2])
C0337552 (UMLS CUI [3])
Residence | Home visit Participation Ability | Mother | Daughter
Item
8. must reside within the united states, puerto rico or guam and therefore able to participate in home visits made by examination management services, inc. (mothers &
boolean
C0237096 (UMLS CUI [1])
C0020043 (UMLS CUI [2,1])
C0679823 (UMLS CUI [2,2])
C0085732 (UMLS CUI [2,3])
C0026591 (UMLS CUI [3])
C0337552 (UMLS CUI [4])
ID.9
Item
daughters)
boolean
Item Group
C0680251 (UMLS CUI)
Breast Carcinoma Progressive | Breast Carcinoma primary second | Mother
Item
1. evidence of progressive breast cancer or 2nd primaries (mothers)
boolean
C0678222 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
C0205436 (UMLS CUI [2,3])
C0026591 (UMLS CUI [3])
Medical condition Pre-existing Excludes Exercise Program | Medical condition Pre-existing Excludes Diet therapy | Hypertensive disease Stage untreated | Orthopedic problem Severe | Hip Replacement Scheduled | Knee Replacement Scheduled | Paralysis | Kidney Failure, Chronic | Dementia | Angina, Unstable | Myocardial Infarction | Congestive heart failure | Lung disease Hospitalization Required | Lung disease Requirement Oxygen | Mother | Daughter
Item
2. pre-existing medical condition(s) that preclude adherence to an unsupervised exercise program or to a diet high in fruits and vegetables, such as the following: untreated stage 3 hypertension; severe orthopedic conditions; scheduled for a hip or knee replacement within 6 months; paralysis; end-stage renal disease; dementia; unstable angina; heart attack, congestive heart failure or pulmonary conditions that have required hospitalization or oxygen within 6 months (mothers & daughters)
boolean
C3843040 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0015259 (UMLS CUI [1,4])
C3484370 (UMLS CUI [1,5])
C3843040 (UMLS CUI [2,1])
C2347662 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C0012159 (UMLS CUI [2,4])
C0020538 (UMLS CUI [3,1])
C1306673 (UMLS CUI [3,2])
C0332155 (UMLS CUI [3,3])
C0029354 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0392806 (UMLS CUI [5,1])
C0205539 (UMLS CUI [5,2])
C0086511 (UMLS CUI [6,1])
C0205539 (UMLS CUI [6,2])
C0522224 (UMLS CUI [7])
C0022661 (UMLS CUI [8])
C0497327 (UMLS CUI [9])
C0002965 (UMLS CUI [10])
C0027051 (UMLS CUI [11])
C0018802 (UMLS CUI [12])
C0024115 (UMLS CUI [13,1])
C1708385 (UMLS CUI [13,2])
C0024115 (UMLS CUI [14,1])
C1514873 (UMLS CUI [14,2])
C0030054 (UMLS CUI [14,3])
C0026591 (UMLS CUI [15])
C0337552 (UMLS CUI [16])
Exercise Duration Frequency | Mother | Daughter
Item
3. currently exercising 30+ minutes/day for 5+ days/week (<150 minutes per week) (mothers & daughters)
boolean
C0015259 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
C0026591 (UMLS CUI [2])
C0337552 (UMLS CUI [3])
Enrollment Weight Reduction Program | Mother | Daughter
Item
4. currently enrolled in a weight loss program (mothers & daughters)
boolean
C1516879 (UMLS CUI [1,1])
C3179079 (UMLS CUI [1,2])
C0026591 (UMLS CUI [2])
C0337552 (UMLS CUI [3])
Residence Institutionalized | Assisted Living Facilities | Skilled nursing facility | Mother | Daughter
Item
5. residing in institutionalized settings, e.g., living in assisted or skilled nursing facilities, and therefore not able to make independent choices about their lifestyle behaviors and participate fully in the intervention (mothers and daughters).
boolean
C0237096 (UMLS CUI [1,1])
C0562359 (UMLS CUI [1,2])
C0872103 (UMLS CUI [2])
C0037265 (UMLS CUI [3])
C0026591 (UMLS CUI [4])
C0337552 (UMLS CUI [5])
Pregnancy | Mother | Daughter
Item
6. currently pregnant (mothers & daughters)
boolean
C0032961 (UMLS CUI [1])
C0026591 (UMLS CUI [2])
C0337552 (UMLS CUI [3])
Prior diagnosis Breast Carcinoma | Daughter
Item
7. a previous diagnosis of breast cancer (daughters).
boolean
C0332132 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0337552 (UMLS CUI [2])
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