ID

26310

Beschrijving

A Yoga and Wellness Program for Breast Cancer Survivors With Persistent Fatigue; ODM derived from: https://clinicaltrials.gov/show/NCT00727662

Link

https://clinicaltrials.gov/show/NCT00727662

Trefwoorden

Versies (1)
  1. 16-10-17 16-10-17 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

16 oktober 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00727662

Engels

Eligibility Breast Cancer NCT00727662

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosed with early, resectable breast cancer (stage i or ii)
Beschrijving

Early-Stage Breast Carcinoma Resectable TNM Breast tumor staging

Datatype

boolean

Alias
UMLS CUI [1,1]
C2986665
UMLS CUI [1,2]
C1514888
UMLS CUI [1,3]
C0474926
completed treatment with surgery, radiation, and/or chemotherapy between 6 months and 5 years previously
Beschrijving

Operative Surgical Procedures Completed | Therapeutic radiology procedure Completed | Chemotherapy Completed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0205197
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0205197
no other cancer in last 5 years, including breast cancer recurrence
Beschrijving

Cancer Other Absent | Breast cancer recurrent Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0278493
UMLS CUI [2,2]
C0332197
postmenopausal women
Beschrijving

Postmenopausal state

Datatype

boolean

Alias
UMLS CUI [1]
C0232970
age 40 - 65
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
reporting persistent cancer-related fatigue
Beschrijving

Fatigue persistent Related to Cancer

Datatype

boolean

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0205322
UMLS CUI [1,3]
C2826292
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence that fatigue is directly related to a medical or psychiatric disorder (e.g., untreated hypothyroidism, diabetes, anemia (defined as hematocrit < 24), chronic fatigue syndrome, current major depression, insomnia, sleep apnea, restless leg syndrome)
Beschrijving

Fatigue Relationship Disease | Fatigue Relationship Mental disorders | Hypothyroidism untreated | Diabetes Mellitus | Anemia | Hematocrit level | Chronic Fatigue Syndrome | Major Depressive Disorder | Sleeplessness | Sleep Apnea Syndromes | Restless Legs Syndrome

Datatype

boolean

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0012634
UMLS CUI [2,1]
C0015672
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0004936
UMLS CUI [3]
C2749407
UMLS CUI [4]
C0011849
UMLS CUI [5]
C0002871
UMLS CUI [6]
C0518014
UMLS CUI [7]
C0015674
UMLS CUI [8]
C1269683
UMLS CUI [9]
C0917801
UMLS CUI [10]
C0037315
UMLS CUI [11]
C0035258
evidence that fatigue is related to other non-cancer related factors (e.g., shift work, recent change in activity or schedule)
Beschrijving

Fatigue Relationship Factor | shift work | Changing Activity | Changing schedule

Datatype

boolean

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C1521761
UMLS CUI [2]
C1658633
UMLS CUI [3,1]
C0392747
UMLS CUI [3,2]
C0441655
UMLS CUI [4]
C3843044
physical problems or conditions that could make yoga unsafe (e.g., serious neck injuries, unstable joints; also severe cachexia, dizziness, bone pain, severe nausea, etc)
Beschrijving

Physical health problems Yoga At risk | Physical Condition Yoga At risk | Neck Injuries Serious | Joint Instability | Cachexia Severe | Dizziness | Bone pain | Nausea Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C1446390
UMLS CUI [1,2]
C2979879
UMLS CUI [1,3]
C1444641
UMLS CUI [2,1]
C3714565
UMLS CUI [2,2]
C2979879
UMLS CUI [2,3]
C1444641
UMLS CUI [3,1]
C0027531
UMLS CUI [3,2]
C0205404
UMLS CUI [4]
C0022410
UMLS CUI [5,1]
C0006625
UMLS CUI [5,2]
C0205082
UMLS CUI [6]
C0012833
UMLS CUI [7]
C0151825
UMLS CUI [8,1]
C0027497
UMLS CUI [8,2]
C0205082
regular use of medications and/or behavioral therapies that would confound evaluation of iy, including regular participation in yoga classes
Beschrijving

Pharmaceutical Preparations Interfere with Evaluation Yoga | Behavior Therapy Interferes with Evaluation Yoga | Participation in yoga Regular

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C1261322
UMLS CUI [1,4]
C2979879
UMLS CUI [2,1]
C0004933
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1261322
UMLS CUI [2,4]
C2979879
UMLS CUI [3,1]
C0454430
UMLS CUI [3,2]
C0205272
presence of medical conditions that involve the immune system and would confound immune evaluation (e.g., autoimmune disorder, inflammatory disease)
Beschrijving

Medical condition Involvement with Immune system | Medical condition Interferes with Immune system evaluation | Autoimmune Diseases | Inflammatory disorder

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C0020962
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0199972
UMLS CUI [3]
C0004364
UMLS CUI [4]
C1290884
use of medications that might confound immune evaluation (e.g., regular use of corticosteroids, narcotics, opiates)
Beschrijving

Pharmaceutical Preparations Interfere with Immune system evaluation | Adrenal Cortex Hormones | Narcotics | Opiates

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0199972
UMLS CUI [2]
C0001617
UMLS CUI [3]
C0027415
UMLS CUI [4]
C0376196
unable to commit to intervention schedule
Beschrijving

Intervention Schedule Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C0030703
UMLS CUI [1,3]
C1299582
body mass index greater than 30 kg/m2
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
regular tobacco (defined as daily or near daily) or alcohol use (defined as > 2 drinks/day)
Beschrijving

Tobacco use Regular | Alcohol consumption Regular | Drinks Quantity per day

Datatype

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0205272
UMLS CUI [2,1]
C0001948
UMLS CUI [2,2]
C0205272
UMLS CUI [3,1]
C0001967
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0439505
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Similar models

Eligibility Breast Cancer NCT00727662

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Early-Stage Breast Carcinoma Resectable TNM Breast tumor staging
Item
diagnosed with early, resectable breast cancer (stage i or ii)
boolean
C2986665 (UMLS CUI [1,1])
C1514888 (UMLS CUI [1,2])
C0474926 (UMLS CUI [1,3])
Operative Surgical Procedures Completed | Therapeutic radiology procedure Completed | Chemotherapy Completed
Item
completed treatment with surgery, radiation, and/or chemotherapy between 6 months and 5 years previously
boolean
C0543467 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
Cancer Other Absent | Breast cancer recurrent Absent
Item
no other cancer in last 5 years, including breast cancer recurrence
boolean
C1707251 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0278493 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Postmenopausal state
Item
postmenopausal women
boolean
C0232970 (UMLS CUI [1])
Age
Item
age 40 - 65
boolean
C0001779 (UMLS CUI [1])
Fatigue persistent Related to Cancer
Item
reporting persistent cancer-related fatigue
boolean
C0015672 (UMLS CUI [1,1])
C0205322 (UMLS CUI [1,2])
C2826292 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Fatigue Relationship Disease | Fatigue Relationship Mental disorders | Hypothyroidism untreated | Diabetes Mellitus | Anemia | Hematocrit level | Chronic Fatigue Syndrome | Major Depressive Disorder | Sleeplessness | Sleep Apnea Syndromes | Restless Legs Syndrome
Item
evidence that fatigue is directly related to a medical or psychiatric disorder (e.g., untreated hypothyroidism, diabetes, anemia (defined as hematocrit < 24), chronic fatigue syndrome, current major depression, insomnia, sleep apnea, restless leg syndrome)
boolean
C0015672 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C0015672 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0004936 (UMLS CUI [2,3])
C2749407 (UMLS CUI [3])
C0011849 (UMLS CUI [4])
C0002871 (UMLS CUI [5])
C0518014 (UMLS CUI [6])
C0015674 (UMLS CUI [7])
C1269683 (UMLS CUI [8])
C0917801 (UMLS CUI [9])
C0037315 (UMLS CUI [10])
C0035258 (UMLS CUI [11])
Fatigue Relationship Factor | shift work | Changing Activity | Changing schedule
Item
evidence that fatigue is related to other non-cancer related factors (e.g., shift work, recent change in activity or schedule)
boolean
C0015672 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C1521761 (UMLS CUI [1,3])
C1658633 (UMLS CUI [2])
C0392747 (UMLS CUI [3,1])
C0441655 (UMLS CUI [3,2])
C3843044 (UMLS CUI [4])
Physical health problems Yoga At risk | Physical Condition Yoga At risk | Neck Injuries Serious | Joint Instability | Cachexia Severe | Dizziness | Bone pain | Nausea Severe
Item
physical problems or conditions that could make yoga unsafe (e.g., serious neck injuries, unstable joints; also severe cachexia, dizziness, bone pain, severe nausea, etc)
boolean
C1446390 (UMLS CUI [1,1])
C2979879 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C3714565 (UMLS CUI [2,1])
C2979879 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C0027531 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0022410 (UMLS CUI [4])
C0006625 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0012833 (UMLS CUI [6])
C0151825 (UMLS CUI [7])
C0027497 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
Pharmaceutical Preparations Interfere with Evaluation Yoga | Behavior Therapy Interferes with Evaluation Yoga | Participation in yoga Regular
Item
regular use of medications and/or behavioral therapies that would confound evaluation of iy, including regular participation in yoga classes
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1261322 (UMLS CUI [1,3])
C2979879 (UMLS CUI [1,4])
C0004933 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
C2979879 (UMLS CUI [2,4])
C0454430 (UMLS CUI [3,1])
C0205272 (UMLS CUI [3,2])
Medical condition Involvement with Immune system | Medical condition Interferes with Immune system evaluation | Autoimmune Diseases | Inflammatory disorder
Item
presence of medical conditions that involve the immune system and would confound immune evaluation (e.g., autoimmune disorder, inflammatory disease)
boolean
C3843040 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C0020962 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0199972 (UMLS CUI [2,3])
C0004364 (UMLS CUI [3])
C1290884 (UMLS CUI [4])
Pharmaceutical Preparations Interfere with Immune system evaluation | Adrenal Cortex Hormones | Narcotics | Opiates
Item
use of medications that might confound immune evaluation (e.g., regular use of corticosteroids, narcotics, opiates)
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0199972 (UMLS CUI [1,3])
C0001617 (UMLS CUI [2])
C0027415 (UMLS CUI [3])
C0376196 (UMLS CUI [4])
Intervention Schedule Unable
Item
unable to commit to intervention schedule
boolean
C0184661 (UMLS CUI [1,1])
C0030703 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Body mass index
Item
body mass index greater than 30 kg/m2
boolean
C1305855 (UMLS CUI [1])
Tobacco use Regular | Alcohol consumption Regular | Drinks Quantity per day
Item
regular tobacco (defined as daily or near daily) or alcohol use (defined as > 2 drinks/day)
boolean
C0543414 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0001948 (UMLS CUI [2,1])
C0205272 (UMLS CUI [2,2])
C0001967 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0439505 (UMLS CUI [3,3])
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