ID

38159

Description

An Internet-based Psychosexual Intervention for Couples Following Treatment for Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01881022

Link

https://clinicaltrials.gov/show/NCT01881022

Keywords

Versions (1)
  1. 9/23/19 9/23/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 23, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01881022

English

Eligibility Breast Cancer NCT01881022

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient has received a diagnosis within the last 5 years of invasive breast carcinoma (non- metastatic), or ductal carcinoma in-situ
Description

Invasive carcinoma of breast | Neoplasm Metastasis Absent | DCIS

Data type

boolean

Alias
UMLS CUI [1]
C0853879
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0007124
patient has received a mastectomy or lumpectomy and undergone adjuvant therapy (i.e.
Description

Mastectomy | Segmental Mastectomy | Adjuvant therapy

Data type

boolean

Alias
UMLS CUI [1]
C0024881
UMLS CUI [2]
C0024885
UMLS CUI [3]
C0677850
chemotherapy, radiation, tamoxifen)
Description

Chemotherapy | Therapeutic radiology procedure | Tamoxifen

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0039286
patient is at least 1 month post-treatment.
Description

Patient post treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C2709088
couples are in a committed relationship of at least 3 months duration at the time of diagnosis
Description

Couples Committed sexual relationship Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0010222
UMLS CUI [1,2]
C0556474
UMLS CUI [1,3]
C0449238
participants must be fluent in english
Description

Able to speak fluently English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0564241
UMLS CUI [1,2]
C0376245
participants must be 80 years of age or younger
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
participants will require convenient access to a computer with a reliable internet connection in a private setting and have access to videoconferencing software (available for download at no cost).
Description

Access Computer | Access Internet | Access Videoconferencing communications

Data type

boolean

Alias
UMLS CUI [1,1]
C0444454
UMLS CUI [1,2]
C0009622
UMLS CUI [2,1]
C0444454
UMLS CUI [2,2]
C0282111
UMLS CUI [3,1]
C0444454
UMLS CUI [3,2]
C1450048
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
one or both of the partners are currently struggling with any mental illness that would interfere with the ability to participate (e.g. actively suicidal; currently psychotic
Description

Mental disorder Interferes with Study Subject Participation Status | Suicidal | Psychotic Disorder

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2]
C0438696
UMLS CUI [3]
C0033975
couples who plan to participate in couples or sex counselling during the study
Description

Couples | Couples counseling Planned | Sex Counseling Planned

Data type

boolean

Alias
UMLS CUI [1]
C0010222
UMLS CUI [2,1]
C1160830
UMLS CUI [2,2]
C1301732
UMLS CUI [3,1]
C0036870
UMLS CUI [3,2]
C1301732
couples experiencing significant levels of relationship distress (e.g. presence of violence or abuse), in which case they will be referred for couple counseling
Description

Couples | Relationship problems | Violence | Abuse | Referral for Couples counseling

Data type

boolean

Alias
UMLS CUI [1]
C0010222
UMLS CUI [2]
C0425168
UMLS CUI [3]
C0042693
UMLS CUI [4]
C1546935
UMLS CUI [5,1]
C2585524
UMLS CUI [5,2]
C1160830
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Similar models

Eligibility Breast Cancer NCT01881022

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast | Neoplasm Metastasis Absent | DCIS
Item
patient has received a diagnosis within the last 5 years of invasive breast carcinoma (non- metastatic), or ductal carcinoma in-situ
boolean
C0853879 (UMLS CUI [1])
C0027627 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0007124 (UMLS CUI [3])
Mastectomy | Segmental Mastectomy | Adjuvant therapy
Item
patient has received a mastectomy or lumpectomy and undergone adjuvant therapy (i.e.
boolean
C0024881 (UMLS CUI [1])
C0024885 (UMLS CUI [2])
C0677850 (UMLS CUI [3])
Chemotherapy | Therapeutic radiology procedure | Tamoxifen
Item
chemotherapy, radiation, tamoxifen)
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0039286 (UMLS CUI [3])
Patient post treatment
Item
patient is at least 1 month post-treatment.
boolean
C0030705 (UMLS CUI [1,1])
C2709088 (UMLS CUI [1,2])
Couples Committed sexual relationship Duration
Item
couples are in a committed relationship of at least 3 months duration at the time of diagnosis
boolean
C0010222 (UMLS CUI [1,1])
C0556474 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Able to speak fluently English Language
Item
participants must be fluent in english
boolean
C0564241 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
Age
Item
participants must be 80 years of age or younger
boolean
C0001779 (UMLS CUI [1])
Access Computer | Access Internet | Access Videoconferencing communications
Item
participants will require convenient access to a computer with a reliable internet connection in a private setting and have access to videoconferencing software (available for download at no cost).
boolean
C0444454 (UMLS CUI [1,1])
C0009622 (UMLS CUI [1,2])
C0444454 (UMLS CUI [2,1])
C0282111 (UMLS CUI [2,2])
C0444454 (UMLS CUI [3,1])
C1450048 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Mental disorder Interferes with Study Subject Participation Status | Suicidal | Psychotic Disorder
Item
one or both of the partners are currently struggling with any mental illness that would interfere with the ability to participate (e.g. actively suicidal; currently psychotic
boolean
C0004936 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0438696 (UMLS CUI [2])
C0033975 (UMLS CUI [3])
Couples | Couples counseling Planned | Sex Counseling Planned
Item
couples who plan to participate in couples or sex counselling during the study
boolean
C0010222 (UMLS CUI [1])
C1160830 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0036870 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
Couples | Relationship problems | Violence | Abuse | Referral for Couples counseling
Item
couples experiencing significant levels of relationship distress (e.g. presence of violence or abuse), in which case they will be referred for couple counseling
boolean
C0010222 (UMLS CUI [1])
C0425168 (UMLS CUI [2])
C0042693 (UMLS CUI [3])
C1546935 (UMLS CUI [4])
C2585524 (UMLS CUI [5,1])
C1160830 (UMLS CUI [5,2])
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