ID

26775

Description

Acupuncture or Medication in Reducing Pain in Postmenopausal Women With Breast Cancer and Joint Pain; ODM derived from: https://clinicaltrials.gov/show/NCT00892268

Lien

https://clinicaltrials.gov/show/NCT00892268

Mots-clés

Versions (1)
  1. 24/10/2017 24/10/2017 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

24 octobre 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00892268

Anglais

Eligibility Breast Cancer NCT00892268

1 Formulaires  
Criteria
Description

Criteria

diagnosis of breast cancer
Description

Breast Carcinoma

Type de données

boolean

Alias
UMLS CUI [1]
C0678222
concurrent therapy with anastrozole for the adjuvant treatment of breast cancer
Description

Anastrozole | Adjuvant therapy Breast Carcinoma

Type de données

boolean

Alias
UMLS CUI [1]
C0290883
UMLS CUI [2,1]
C0677850
UMLS CUI [2,2]
C0678222
must have moderate or worse arthralgia, as defined by a baseline womac pain scale score ≥ 48
Description

Arthralgia Moderate WOMAC scale | Arthralgia Worse WOMAC scale

Type de données

boolean

Alias
UMLS CUI [1,1]
C0003862
UMLS CUI [1,2]
C0205081
UMLS CUI [1,3]
C3472647
UMLS CUI [2,1]
C0003862
UMLS CUI [2,2]
C1457868
UMLS CUI [2,3]
C3472647
patients with other underlying pain syndromes (e.g., osteoarthritis) are eligible, but the arthralgia must have worsened since starting anastrozole
Description

Pain Disorder | Osteoarthritis | Anastrozole Started | Arthralgia Worsened

Type de données

boolean

Alias
UMLS CUI [1]
C0391976
UMLS CUI [2]
C0029408
UMLS CUI [3,1]
C0290883
UMLS CUI [3,2]
C1272689
UMLS CUI [4,1]
C0003862
UMLS CUI [4,2]
C1457868
hormone receptor-positive disease
Description

Disease Hormone Receptor Positive

Type de données

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0019929
UMLS CUI [1,3]
C1514241
patient characteristics:
Description

Client Characteristics

Type de données

boolean

Alias
UMLS CUI [1]
C0815172
post-menopausal status meeting the following criteria:
Description

Postmenopausal state

Type de données

boolean

Alias
UMLS CUI [1]
C0232970
at least 12 months without spontaneous menstrual bleeding
Description

Absence Menstruation Spontaneous Duration

Type de données

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0025344
UMLS CUI [1,3]
C0205359
UMLS CUI [1,4]
C0449238
history of bilateral salpingo-oophorectomy with or without hysterectomy
Description

Bilateral salpingectomy with oophorectomy | Hysterectomy

Type de données

boolean

Alias
UMLS CUI [1]
C0195495
UMLS CUI [2]
C0020699
age > 55 with hysterectomy with or without oophorectomy
Description

Age | Hysterectomy | Ovariectomy

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0020699
UMLS CUI [3]
C0029936
age < 55 with hysterectomy without oophorectomy or with unknown status, and serum fsh in post-menopausal range within the past 4 weeks
Description

Age | Hysterectomy Without Ovariectomy | Hysterectomy Status Unknown | Serum FSH measurement Postmenopausal state

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0020699
UMLS CUI [2,2]
C0332288
UMLS CUI [2,3]
C0029936
UMLS CUI [3,1]
C0020699
UMLS CUI [3,2]
C0449438
UMLS CUI [3,3]
C0439673
UMLS CUI [4,1]
C0455276
UMLS CUI [4,2]
C0232970
not needle phobic
Description

Needle phobia Absent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0338906
UMLS CUI [1,2]
C0332197
patients with a contraindication to nsaids (i.e., prior gastrointestinal bleed secondary to nsaids or severe renal insufficiency) are eligible, but will be treated with alternative analgesics such as narcotics or acetaminophen
Description

Medical contraindication NSAIDS | Gastrointestinal Hemorrhage Secondary to NSAIDS | Gastrointestinal Hemorrhage Secondary to Renal Insufficiency Severe | Analgesics Alternative | Narcotics | Acetaminophen

Type de données

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0003211
UMLS CUI [2,1]
C0017181
UMLS CUI [2,2]
C0175668
UMLS CUI [2,3]
C0003211
UMLS CUI [3,1]
C0017181
UMLS CUI [3,2]
C0175668
UMLS CUI [3,3]
C1565489
UMLS CUI [3,4]
C0205082
UMLS CUI [4,1]
C0002771
UMLS CUI [4,2]
C1523987
UMLS CUI [5]
C0027415
UMLS CUI [6]
C0000970
prior concurrent therapy:
Description

Therapeutic procedure

Type de données

boolean

Alias
UMLS CUI [1]
C0087111
see disease characteristics
Description

ID.15

Type de données

boolean

concurrent chronic narcotics or nsaids allowed, but doses must be stable for ≥ the past month
Description

Narcotics chronic Dose Stable | Non-Steroidal Anti-Inflammatory Agents chronic Dose Stable

Type de données

boolean

Alias
UMLS CUI [1,1]
C0027415
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0205360
UMLS CUI [2,1]
C0003211
UMLS CUI [2,2]
C0205191
UMLS CUI [2,3]
C0178602
UMLS CUI [2,4]
C0205360
concurrent antidepressant medications allowed, but doses must be stable for ≥ the past 3 months
Description

Antidepressive Agents Dose Stable

Type de données

boolean

Alias
UMLS CUI [1,1]
C0003289
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
at least 6 months since prior acupuncture
Description

Acupuncture Previous

Type de données

boolean

Alias
UMLS CUI [1,1]
C0394664
UMLS CUI [1,2]
C0205156
no prior acupuncture for aromatase inhibitor-associated pain syndrome
Description

Pain Disorder Associated with Aromatase Inhibitors | Acupuncture Previous Excluded

Type de données

boolean

Alias
UMLS CUI [1,1]
C0391976
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0593802
UMLS CUI [2,1]
C0394664
UMLS CUI [2,2]
C0205156
UMLS CUI [2,3]
C2828389
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Similar models

Eligibility Breast Cancer NCT00892268

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Breast Carcinoma
Item
diagnosis of breast cancer
boolean
C0678222 (UMLS CUI [1])
Anastrozole | Adjuvant therapy Breast Carcinoma
Item
concurrent therapy with anastrozole for the adjuvant treatment of breast cancer
boolean
C0290883 (UMLS CUI [1])
C0677850 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
Arthralgia Moderate WOMAC scale | Arthralgia Worse WOMAC scale
Item
must have moderate or worse arthralgia, as defined by a baseline womac pain scale score ≥ 48
boolean
C0003862 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C3472647 (UMLS CUI [1,3])
C0003862 (UMLS CUI [2,1])
C1457868 (UMLS CUI [2,2])
C3472647 (UMLS CUI [2,3])
Pain Disorder | Osteoarthritis | Anastrozole Started | Arthralgia Worsened
Item
patients with other underlying pain syndromes (e.g., osteoarthritis) are eligible, but the arthralgia must have worsened since starting anastrozole
boolean
C0391976 (UMLS CUI [1])
C0029408 (UMLS CUI [2])
C0290883 (UMLS CUI [3,1])
C1272689 (UMLS CUI [3,2])
C0003862 (UMLS CUI [4,1])
C1457868 (UMLS CUI [4,2])
Disease Hormone Receptor Positive
Item
hormone receptor-positive disease
boolean
C0012634 (UMLS CUI [1,1])
C0019929 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Postmenopausal state
Item
post-menopausal status meeting the following criteria:
boolean
C0232970 (UMLS CUI [1])
Absence Menstruation Spontaneous Duration
Item
at least 12 months without spontaneous menstrual bleeding
boolean
C0332197 (UMLS CUI [1,1])
C0025344 (UMLS CUI [1,2])
C0205359 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,4])
Bilateral salpingectomy with oophorectomy | Hysterectomy
Item
history of bilateral salpingo-oophorectomy with or without hysterectomy
boolean
C0195495 (UMLS CUI [1])
C0020699 (UMLS CUI [2])
Age | Hysterectomy | Ovariectomy
Item
age > 55 with hysterectomy with or without oophorectomy
boolean
C0001779 (UMLS CUI [1])
C0020699 (UMLS CUI [2])
C0029936 (UMLS CUI [3])
Age | Hysterectomy Without Ovariectomy | Hysterectomy Status Unknown | Serum FSH measurement Postmenopausal state
Item
age < 55 with hysterectomy without oophorectomy or with unknown status, and serum fsh in post-menopausal range within the past 4 weeks
boolean
C0001779 (UMLS CUI [1])
C0020699 (UMLS CUI [2,1])
C0332288 (UMLS CUI [2,2])
C0029936 (UMLS CUI [2,3])
C0020699 (UMLS CUI [3,1])
C0449438 (UMLS CUI [3,2])
C0439673 (UMLS CUI [3,3])
C0455276 (UMLS CUI [4,1])
C0232970 (UMLS CUI [4,2])
Needle phobia Absent
Item
not needle phobic
boolean
C0338906 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Medical contraindication NSAIDS | Gastrointestinal Hemorrhage Secondary to NSAIDS | Gastrointestinal Hemorrhage Secondary to Renal Insufficiency Severe | Analgesics Alternative | Narcotics | Acetaminophen
Item
patients with a contraindication to nsaids (i.e., prior gastrointestinal bleed secondary to nsaids or severe renal insufficiency) are eligible, but will be treated with alternative analgesics such as narcotics or acetaminophen
boolean
C1301624 (UMLS CUI [1,1])
C0003211 (UMLS CUI [1,2])
C0017181 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C0003211 (UMLS CUI [2,3])
C0017181 (UMLS CUI [3,1])
C0175668 (UMLS CUI [3,2])
C1565489 (UMLS CUI [3,3])
C0205082 (UMLS CUI [3,4])
C0002771 (UMLS CUI [4,1])
C1523987 (UMLS CUI [4,2])
C0027415 (UMLS CUI [5])
C0000970 (UMLS CUI [6])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
ID.15
Item
see disease characteristics
boolean
Narcotics chronic Dose Stable | Non-Steroidal Anti-Inflammatory Agents chronic Dose Stable
Item
concurrent chronic narcotics or nsaids allowed, but doses must be stable for ≥ the past month
boolean
C0027415 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
C0003211 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0205360 (UMLS CUI [2,4])
Antidepressive Agents Dose Stable
Item
concurrent antidepressant medications allowed, but doses must be stable for ≥ the past 3 months
boolean
C0003289 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Acupuncture Previous
Item
at least 6 months since prior acupuncture
boolean
C0394664 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Pain Disorder Associated with Aromatase Inhibitors | Acupuncture Previous Excluded
Item
no prior acupuncture for aromatase inhibitor-associated pain syndrome
boolean
C0391976 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0593802 (UMLS CUI [1,3])
C0394664 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C2828389 (UMLS CUI [2,3])
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