ID

44296

Description

Acupuncture in Treating Women With Stage I, Stage II, or Stage III Breast Cancer With Aromatase Inhibitor-Related Joint Pain; ODM derived from: https://clinicaltrials.gov/show/NCT01013337

Link

https://clinicaltrials.gov/show/NCT01013337

Keywords

Versions (2)
  1. 10/30/17 10/30/17 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01013337

English

Eligibility Breast Cancer NCT01013337

1 forms  
Criteria
Description

Criteria

history of stage i, ii, or iii breast cancer
Description

Breast Carcinoma TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0474926
visit with oncologist within the previous 3-month period and free of disease by clinical examination and history
Description

Patient Visit Oncologist | Disease Free of Clinical examination

Data type

boolean

Alias
UMLS CUI [1,1]
C1512346
UMLS CUI [1,2]
C0259990
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0332296
UMLS CUI [2,3]
C1456356
currently receiving aromatase inhibitors (anastrozole, letrozole, or exemestane) as per chart abstraction
Description

Aromatase Inhibitors | anastrozole | letrozole | exemestane

Data type

boolean

Alias
UMLS CUI [1]
C0593802
UMLS CUI [2]
C0290883
UMLS CUI [3]
C0246421
UMLS CUI [4]
C0851344
postmenopausal, as defined by cessation of menses for a least 1 year or fsh > 40 mlu/ml
Description

Postmenopausal state | Amenorrhea Duration | Follicle stimulating hormone measurement

Data type

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2,1]
C0002453
UMLS CUI [2,2]
C0449238
UMLS CUI [3]
C0202022
can understand written english
Description

Comprehension English Language Written

Data type

boolean

Alias
UMLS CUI [1,1]
C0233733
UMLS CUI [1,2]
C0376245
UMLS CUI [1,3]
C0681288
having worst joint pain rated at least 4 or greater on an 11-point (0-10) numerical rating scale in the preceding week
Description

Arthralgia Worst Numeric Pain Scale

Data type

boolean

Alias
UMLS CUI [1,1]
C0003862
UMLS CUI [1,2]
C1522166
UMLS CUI [1,3]
C1518471
having had at least 15 days with pain in the preceding 30 days
Description

Pain Frequency

Data type

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0439603
having had joint pain for at least 3 months
Description

Arthralgia Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0003862
UMLS CUI [1,2]
C0872146
joint pain attributed to the use of aromatase inhibitors
Description

Arthralgia | Aromatase Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0003862
UMLS CUI [2]
C0593802
willingness to adhere to all study-related procedures including randomization to one of the three possible choices: real acupuncture, placebo acupuncture, and wait-list control
Description

Protocol Compliance | Acupuncture procedure | Acupuncture Placebos | Wait List control

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0394664
UMLS CUI [3,1]
C0394664
UMLS CUI [3,2]
C0032042
UMLS CUI [4,1]
C0043010
UMLS CUI [4,2]
C0243148
exclusion
Description

Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
women with metastatic (stage iv) breast cancer
Description

Secondary malignant neoplasm of female breast TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0346993
UMLS CUI [1,2]
C0474926
women having finished chemotherapy or radiation therapy less than 4 weeks prior to enrollment
Description

Gender | Chemotherapy Completed | Therapeutic radiology procedure Completed

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0205197
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0205197
history of bleeding disorder
Description

Blood Coagulation Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0005779
joint pain attributed to inflammatory arthritis (such as rheumatoid arthritis, gout, pseudo gout)
Description

Arthralgia | Arthritis | Rheumatoid Arthritis | Gout | Pseudogout

Data type

boolean

Alias
UMLS CUI [1]
C0003862
UMLS CUI [2]
C0003864
UMLS CUI [3]
C0003873
UMLS CUI [4]
C0018099
UMLS CUI [5]
C0033802
having severe pain or non-inflammatory arthralgia prior to ai initiation per patient's history
Description

Severe pain | Arthralgia | Aromatase Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0278140
UMLS CUI [2]
C0003862
UMLS CUI [3]
C0593802
surgery or joint injection involving the treatment joint within the last 3 months
Description

Operative Surgical Procedures Joint Involved | Joint injection Joint Involved

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0022417
UMLS CUI [1,3]
C1314939
UMLS CUI [2,1]
C0021488
UMLS CUI [2,2]
C0022417
UMLS CUI [2,3]
C1314939
have previously participated in the acupuncture trial for hot flashes in the last year
Description

Study Subject Participation Status | Acupuncture Trial Hot flashes

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0394664
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C0600142
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Similar models

Eligibility Breast Cancer NCT01013337

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Breast Carcinoma TNM Breast tumor staging
Item
history of stage i, ii, or iii breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Patient Visit Oncologist | Disease Free of Clinical examination
Item
visit with oncologist within the previous 3-month period and free of disease by clinical examination and history
boolean
C1512346 (UMLS CUI [1,1])
C0259990 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
C1456356 (UMLS CUI [2,3])
Aromatase Inhibitors | anastrozole | letrozole | exemestane
Item
currently receiving aromatase inhibitors (anastrozole, letrozole, or exemestane) as per chart abstraction
boolean
C0593802 (UMLS CUI [1])
C0290883 (UMLS CUI [2])
C0246421 (UMLS CUI [3])
C0851344 (UMLS CUI [4])
Postmenopausal state | Amenorrhea Duration | Follicle stimulating hormone measurement
Item
postmenopausal, as defined by cessation of menses for a least 1 year or fsh > 40 mlu/ml
boolean
C0232970 (UMLS CUI [1])
C0002453 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0202022 (UMLS CUI [3])
Comprehension English Language Written
Item
can understand written english
boolean
C0233733 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0681288 (UMLS CUI [1,3])
Arthralgia Worst Numeric Pain Scale
Item
having worst joint pain rated at least 4 or greater on an 11-point (0-10) numerical rating scale in the preceding week
boolean
C0003862 (UMLS CUI [1,1])
C1522166 (UMLS CUI [1,2])
C1518471 (UMLS CUI [1,3])
Pain Frequency
Item
having had at least 15 days with pain in the preceding 30 days
boolean
C0030193 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Arthralgia Disease length
Item
having had joint pain for at least 3 months
boolean
C0003862 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Arthralgia | Aromatase Inhibitors
Item
joint pain attributed to the use of aromatase inhibitors
boolean
C0003862 (UMLS CUI [1])
C0593802 (UMLS CUI [2])
Protocol Compliance | Acupuncture procedure | Acupuncture Placebos | Wait List control
Item
willingness to adhere to all study-related procedures including randomization to one of the three possible choices: real acupuncture, placebo acupuncture, and wait-list control
boolean
C0525058 (UMLS CUI [1])
C0394664 (UMLS CUI [2])
C0394664 (UMLS CUI [3,1])
C0032042 (UMLS CUI [3,2])
C0043010 (UMLS CUI [4,1])
C0243148 (UMLS CUI [4,2])
Exclusion Criteria
Item
exclusion
boolean
C0680251 (UMLS CUI [1])
Secondary malignant neoplasm of female breast TNM Breast tumor staging
Item
women with metastatic (stage iv) breast cancer
boolean
C0346993 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Gender | Chemotherapy Completed | Therapeutic radiology procedure Completed
Item
women having finished chemotherapy or radiation therapy less than 4 weeks prior to enrollment
boolean
C0079399 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
Blood Coagulation Disorders
Item
history of bleeding disorder
boolean
C0005779 (UMLS CUI [1])
Arthralgia | Arthritis | Rheumatoid Arthritis | Gout | Pseudogout
Item
joint pain attributed to inflammatory arthritis (such as rheumatoid arthritis, gout, pseudo gout)
boolean
C0003862 (UMLS CUI [1])
C0003864 (UMLS CUI [2])
C0003873 (UMLS CUI [3])
C0018099 (UMLS CUI [4])
C0033802 (UMLS CUI [5])
Severe pain | Arthralgia | Aromatase Inhibitors
Item
having severe pain or non-inflammatory arthralgia prior to ai initiation per patient's history
boolean
C0278140 (UMLS CUI [1])
C0003862 (UMLS CUI [2])
C0593802 (UMLS CUI [3])
Operative Surgical Procedures Joint Involved | Joint injection Joint Involved
Item
surgery or joint injection involving the treatment joint within the last 3 months
boolean
C0543467 (UMLS CUI [1,1])
C0022417 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
C0021488 (UMLS CUI [2,1])
C0022417 (UMLS CUI [2,2])
C1314939 (UMLS CUI [2,3])
Study Subject Participation Status | Acupuncture Trial Hot flashes
Item
have previously participated in the acupuncture trial for hot flashes in the last year
boolean
C2348568 (UMLS CUI [1])
C0394664 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0600142 (UMLS CUI [2,3])
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