ID

44728

Description

Therapy to Prevent Sexual Pain in Breast Cancer Survivors; ODM derived from: https://clinicaltrials.gov/show/NCT01539317

Link

https://clinicaltrials.gov/show/NCT01539317

Keywords

Versions (1)
  1. 9/30/21 9/30/21 -
Copyright Holder

OHSU Knight Cancer Institute

Uploaded on

September 30, 2021

DOI

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License

Creative Commons BY-NC 4.0
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Eligibility Vulvodynia NCT01539317

English

Eligibility Vulvodynia NCT01539317

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Vulvodynia NCT01539317
Eligibility Criteria
Description

Eligibility Criteria

Alias
UMLS CUI [1]
C1512693
1. women aged 18 to 70 years old.
Description

Female | Age

Data type

boolean

Alias
UMLS CUI [1]
C0086287
UMLS CUI [2]
C0001779
2. has a previous diagnosis of breast cancer (ductal or lobular carcinoma, invasive).
Description

Previous diagnosis of breast cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0262926
3. 1 year from diagnosis of breast cancer.
Description

A date of diagnosis of breast cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C2316983
4. stable heterosexual partnership =/>5 years or by investigator discretion.
Description

Stable heterosexual relationship

Data type

boolean

Alias
UMLS CUI [1,1]
C0205360
UMLS CUI [1,2]
C0556476
5. more than 6 months of consistent insertional pain with intercourse (may have stopped having intercourse due to this consistent experience of pain).
Description

Duration of dyspareunia

Data type

boolean

Alias
UMLS CUI [1,1]
C1384606
UMLS CUI [1,2]
C0449238
6. menopausal, demonstrated by at least one of the following:
Description

Menopause status demonstrated by following criteria:

Data type

boolean

Alias
UMLS CUI [1,1]
C3829127
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C0332282
i. cessation of menses for 1 years ii. bilateral oophorectomy iii. follicle stimulating hormone (fsh) level >25 in women below age 50 with an ovary and scarred or absent uterus (acceptable fsh levels can be inferred if the woman's oncologist monitors fsh during aromatase inhibitor therapy).
Description

Cessation of menses | Bilateral oophorectomy | Follicle stimulating hormone (fsh) level in women below age 50 with an ovary and scarred or absent uterus

Data type

boolean

Alias
UMLS CUI [1,1]
C0002453
UMLS CUI [1,2]
C0449238
UMLS CUI [2]
C0278321
UMLS CUI [3,1]
C0202022
UMLS CUI [3,2]
C0001779
UMLS CUI [3,3]
C0086287
UMLS CUI [3,4]
C0029939
UMLS CUI [3,5]
C0150312
UMLS CUI [3,6]
C0042149
UMLS CUI [3,7]
C0241158
UMLS CUI [4,1]
C0202022
UMLS CUI [4,2]
C0001779
UMLS CUI [4,3]
C0086287
UMLS CUI [4,4]
C0029939
UMLS CUI [4,5]
C0150312
UMLS CUI [4,6]
C0425913
7. willingness to enter a study comparing a topical placebo liquid to topical liquid lidocaine.
Description

Willingness to enter a study comparing a topical placebo liquid to topical liquid lidocaine.

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0600109
UMLS CUI [2,1]
C0023660
UMLS CUI [2,2]
C0032042
UMLS CUI [2,3]
C0302908
UMLS CUI [2,4]
C1522168
UMLS CUI [2,5]
C1707455
8. willingness to evaluate the liquids by use of a tampon test as many as 4 times per month, and willingness to attempt intercourse if the tampon test indicates tolerable penetrative pain.
Description

Willing to evaluate the liquids by use of a tampon test | Willing to attempt an intercourse if the tampon test indicates tolerable penetrative pain

Data type

boolean

Alias
UMLS CUI [1,1]
C0302908
UMLS CUI [1,2]
C1704612
UMLS CUI [1,3]
C0220825
UMLS CUI [1,4]
C0600109
UMLS CUI [2,1]
C0009253
UMLS CUI [2,2]
C0600109
UMLS CUI [2,3]
C0030193
UMLS CUI [2,4]
C4053931
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI [1]
C0680251
1. diagnosis of benign or malignant phyllodes tumor of the breast.
Description

Benign phyllodes tumor of the breast | Malignant phyllodes tumor of the breast

Data type

boolean

Alias
UMLS CUI [1]
C0334501
UMLS CUI [2,1]
C0010701
UMLS CUI [2,2]
C0006826
UMLS CUI [2,3]
C0006141
2. consistently has pain in the pelvis or low abdomen during or after intercourse (deep dyspareunia).
Description

Deep dyspareunia

Data type

boolean

Alias
UMLS CUI [1,1]
C1384606
UMLS CUI [1,2]
C0205125
3. has developed shrinkage of the vaginal opening or vaginal length to the point of being too small to succeed in having vaginal penetration with the partner (will also be assessed at the clinical exam).
Description

Stricture of vagina to the point of being unable to succeed in having vaginal penetration | Physical examination

Data type

boolean

Alias
UMLS CUI [1,1]
C0269208
UMLS CUI [1,2]
C0556623
UMLS CUI [1,3]
C1299582
UMLS CUI [2]
C0031809
4. partner has a problem of sexual dysfunction limiting his performance or making it inconsistent.
Description

Partner has a problem of sexual dysfunction

Data type

boolean

Alias
UMLS CUI [1,1]
C0036911
UMLS CUI [1,2]
C0549622
5. the potential subject or her partner has a serious current medical condition that might interrupt completion of a 6 month study.
Description

Serious current medical condition of a patient or her partner that might interrupt a study

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0439801
UMLS CUI [2,1]
C0682323
UMLS CUI [2,2]
C3843040
UMLS CUI [2,3]
C2348568
UMLS CUI [2,4]
C0439801
6. potential subject has been diagnosed by a physical therapist with significant pelvic floor muscle dysfunction causing pain (pelvic floor myalgia).
Description

Pelvic floor myalgia

Data type

boolean

Alias
UMLS CUI [1]
C4076753
7. potential subject has used topical or systemic estrogen within the last 4 months.
Description

Recent use of topical estrogen | Recent use of systemic estrogen

Data type

boolean

Alias
UMLS CUI [1,1]
C3541386
UMLS CUI [1,2]
C1522168
UMLS CUI [1,3]
C0332185
UMLS CUI [2,1]
C3541386
UMLS CUI [2,2]
C1515119
UMLS CUI [2,3]
C0332185
8. has continued tenderness of vestibule mucosa immediately after application of both test liquids.
Description

Tenderness of vestibule mucosa immediately after application of both test liquids

Data type

boolean

Alias
UMLS CUI [1,1]
C0185125
UMLS CUI [1,2]
C0020517
UMLS CUI [1,3]
C0227765
UMLS CUI [1,4]
C0234242
9. allergy to lidocaine or other numbing agents.
Description

Lidocaine hypersensitivity | Hypersensitivity to local anaesthetics

Data type

boolean

Alias
UMLS CUI [1,1]
C0023660
UMLS CUI [1,2]
C0020517
UMLS CUI [2,1]
C0002934
UMLS CUI [2,2]
C0020517
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Similar models

Eligibility Vulvodynia NCT01539317

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Vulvodynia NCT01539317
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Eligibility Criteria
C1512693 (UMLS CUI [1])
Female | Age
Item
1. women aged 18 to 70 years old.
boolean
C0086287 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Previous diagnosis of breast cancer
Item
2. has a previous diagnosis of breast cancer (ductal or lobular carcinoma, invasive).
boolean
C0678222 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
A date of diagnosis of breast cancer
Item
3. 1 year from diagnosis of breast cancer.
boolean
C0678222 (UMLS CUI [1,1])
C2316983 (UMLS CUI [1,2])
Stable heterosexual relationship
Item
4. stable heterosexual partnership =/>5 years or by investigator discretion.
boolean
C0205360 (UMLS CUI [1,1])
C0556476 (UMLS CUI [1,2])
Duration of dyspareunia
Item
5. more than 6 months of consistent insertional pain with intercourse (may have stopped having intercourse due to this consistent experience of pain).
boolean
C1384606 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Menopause status demonstrated by following criteria:
Item
6. menopausal, demonstrated by at least one of the following:
boolean
C3829127 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C0332282 (UMLS CUI [1,3])
Cessation of menses | Bilateral oophorectomy | Follicle stimulating hormone (fsh) level in women below age 50 with an ovary and scarred or absent uterus
Item
i. cessation of menses for 1 years ii. bilateral oophorectomy iii. follicle stimulating hormone (fsh) level >25 in women below age 50 with an ovary and scarred or absent uterus (acceptable fsh levels can be inferred if the woman's oncologist monitors fsh during aromatase inhibitor therapy).
boolean
C0002453 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0278321 (UMLS CUI [2])
C0202022 (UMLS CUI [3,1])
C0001779 (UMLS CUI [3,2])
C0086287 (UMLS CUI [3,3])
C0029939 (UMLS CUI [3,4])
C0150312 (UMLS CUI [3,5])
C0042149 (UMLS CUI [3,6])
C0241158 (UMLS CUI [3,7])
C0202022 (UMLS CUI [4,1])
C0001779 (UMLS CUI [4,2])
C0086287 (UMLS CUI [4,3])
C0029939 (UMLS CUI [4,4])
C0150312 (UMLS CUI [4,5])
C0425913 (UMLS CUI [4,6])
Willingness to enter a study comparing a topical placebo liquid to topical liquid lidocaine.
Item
7. willingness to enter a study comparing a topical placebo liquid to topical liquid lidocaine.
boolean
C2348568 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0023660 (UMLS CUI [2,1])
C0032042 (UMLS CUI [2,2])
C0302908 (UMLS CUI [2,3])
C1522168 (UMLS CUI [2,4])
C1707455 (UMLS CUI [2,5])
Willing to evaluate the liquids by use of a tampon test | Willing to attempt an intercourse if the tampon test indicates tolerable penetrative pain
Item
8. willingness to evaluate the liquids by use of a tampon test as many as 4 times per month, and willingness to attempt intercourse if the tampon test indicates tolerable penetrative pain.
boolean
C0302908 (UMLS CUI [1,1])
C1704612 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
C0600109 (UMLS CUI [1,4])
C0009253 (UMLS CUI [2,1])
C0600109 (UMLS CUI [2,2])
C0030193 (UMLS CUI [2,3])
C4053931 (UMLS CUI [2,4])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI [1])
Benign phyllodes tumor of the breast | Malignant phyllodes tumor of the breast
Item
1. diagnosis of benign or malignant phyllodes tumor of the breast.
boolean
C0334501 (UMLS CUI [1])
C0010701 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C0006141 (UMLS CUI [2,3])
Deep dyspareunia
Item
2. consistently has pain in the pelvis or low abdomen during or after intercourse (deep dyspareunia).
boolean
C1384606 (UMLS CUI [1,1])
C0205125 (UMLS CUI [1,2])
Stricture of vagina to the point of being unable to succeed in having vaginal penetration | Physical examination
Item
3. has developed shrinkage of the vaginal opening or vaginal length to the point of being too small to succeed in having vaginal penetration with the partner (will also be assessed at the clinical exam).
boolean
C0269208 (UMLS CUI [1,1])
C0556623 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0031809 (UMLS CUI [2])
Partner has a problem of sexual dysfunction
Item
4. partner has a problem of sexual dysfunction limiting his performance or making it inconsistent.
boolean
C0036911 (UMLS CUI [1,1])
C0549622 (UMLS CUI [1,2])
Serious current medical condition of a patient or her partner that might interrupt a study
Item
5. the potential subject or her partner has a serious current medical condition that might interrupt completion of a 6 month study.
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0682323 (UMLS CUI [2,1])
C3843040 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0439801 (UMLS CUI [2,4])
Pelvic floor myalgia
Item
6. potential subject has been diagnosed by a physical therapist with significant pelvic floor muscle dysfunction causing pain (pelvic floor myalgia).
boolean
C4076753 (UMLS CUI [1])
Recent use of topical estrogen | Recent use of systemic estrogen
Item
7. potential subject has used topical or systemic estrogen within the last 4 months.
boolean
C3541386 (UMLS CUI [1,1])
C1522168 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C3541386 (UMLS CUI [2,1])
C1515119 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
Tenderness of vestibule mucosa immediately after application of both test liquids
Item
8. has continued tenderness of vestibule mucosa immediately after application of both test liquids.
boolean
C0185125 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0227765 (UMLS CUI [1,3])
C0234242 (UMLS CUI [1,4])
Lidocaine hypersensitivity | Hypersensitivity to local anaesthetics
Item
9. allergy to lidocaine or other numbing agents.
boolean
C0023660 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0002934 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
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