ID

27175

Beschrijving

Multi-Media Imagery Program for Breast Cancer Patients (Phase II); ODM derived from: https://clinicaltrials.gov/show/NCT01034215

Link

https://clinicaltrials.gov/show/NCT01034215

Trefwoorden

Versies (1)
  1. 02-11-17 02-11-17 -
Houder van rechten

See clinicaltrials.gov

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2 november 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01034215

Engels

Eligibility Breast Cancer NCT01034215

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants must be a community-dwelling member 18 years of age or older. - the participant must be at least 18 because the assessment tools are not validated for use in minors.
Beschrijving

Community Dwelling Member | Age | Adult

Datatype

boolean

Alias
UMLS CUI [1,1]
C4045975
UMLS CUI [1,2]
C0680022
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0001675
participants should be able to read, write, and speak english.
Beschrijving

Able to read English Language | Able to write English Language | Able to speak English Language

Datatype

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0584993
UMLS CUI [2,2]
C0376245
UMLS CUI [3,1]
C0564215
UMLS CUI [3,2]
C0376245
participants must have been diagnosed with breast cancer and have completed surgery, which did not include level iii dissection of the axilla.
Beschrijving

Breast Carcinoma | Operative Surgical Procedures Completed | Axilla Dissection Level Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0205197
UMLS CUI [3,1]
C0004454
UMLS CUI [3,2]
C0012737
UMLS CUI [3,3]
C0441889
UMLS CUI [3,4]
C0332197
participants must obtain verification of diagnosis and treatment from their physician.
Beschrijving

Diagnosis verified Physician | Therapeutic procedure verified Physician

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C3834725
UMLS CUI [1,3]
C0031831
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C3834725
UMLS CUI [2,3]
C0031831
participants must agree to complete assessment instruments and take part in psychophysiological data gathering at baseline, 8 and 17 weeks and to provide required demographic information.
Beschrijving

Assessment Instruments Completion | Participation Data Collection Psychological | Participation Data Collection Physiological | Information Demographic Provide

Datatype

boolean

Alias
UMLS CUI [1,1]
C1255665
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0679823
UMLS CUI [2,2]
C0010995
UMLS CUI [2,3]
C0205486
UMLS CUI [3,1]
C0679823
UMLS CUI [3,2]
C0010995
UMLS CUI [3,3]
C0205463
UMLS CUI [4,1]
C1533716
UMLS CUI [4,2]
C0011298
UMLS CUI [4,3]
C1999230
participants must sign informed consent, stating he/she understands the nature of the research and that he/she wishes to participate in the study. -
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
participants must agree to complete the required diaries, graphs and notebooks related to behavior assessment.
Beschrijving

Subject Diary Completion | Graph Completion | Assessment: Health Behavior

Datatype

boolean

Alias
UMLS CUI [1,1]
C3890583
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0681493
UMLS CUI [2,2]
C0205197
UMLS CUI [3]
C0549072
participants must display the ability to understand and respond to the assessment process and must demonstrate they are oriented to person, place, and time.
Beschrijving

Comprehension Assessment procedure | Orientation to person | Orientation to place | Orientation to time

Datatype

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C1261322
UMLS CUI [2]
C2371003
UMLS CUI [3]
C2370999
UMLS CUI [4]
C0599544
participants must agree to fully participate in all five imagery classes and to practice imagery skills for 20 minutes a day for 17 weeks.
Beschrijving

Participation Imagery therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0589219
participants must have completed major cancer treatment (i.e., surgery, and/or radiation and/or iv chemotherapy) for six weeks; participant must be visual and hearing capable.
Beschrijving

Cancer treatment Major Completed | Operative Surgical Procedures | Therapeutic radiology procedure | Intravenous chemotherapy | Normal vision | Hearing normal

Datatype

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C0205197
UMLS CUI [2]
C0543467
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0413365
UMLS CUI [5]
C0234622
UMLS CUI [6]
C0234725
oral chemotherapy does not preclude participation.
Beschrijving

Oral chemotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0419073
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
participant will be excluded if he/she has a history of uncontrolled epileptic seizures.
Beschrijving

Epilepsy Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0014544
UMLS CUI [1,2]
C0205318
the investigators will exclude patients who cannot speak, read and write english.
Beschrijving

Lacking Able to speak English Language | Lacking Able to read English Language | Lacking Able to write English Language

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0564215
UMLS CUI [1,3]
C0376245
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C0586740
UMLS CUI [2,3]
C0376245
UMLS CUI [3,1]
C0332268
UMLS CUI [3,2]
C0584993
UMLS CUI [3,3]
C0376245
patients will be excluded if they are not oriented to place, person, and time.
Beschrijving

Lacking Orientation to place | Lacking Orientation to person | Lacking Orientation to time

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2370999
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C2371003
UMLS CUI [3,1]
C0332268
UMLS CUI [3,2]
C0599544
participants will be excluded if they have a major psychiatric diagnosis (schizophrenia, bi-polar disorder).
Beschrijving

Psychiatric Diagnosis Major | Schizophrenia | Bipolar Disorder

Datatype

boolean

Alias
UMLS CUI [1,1]
C0376338
UMLS CUI [1,2]
C0205164
UMLS CUI [2]
C0036341
UMLS CUI [3]
C0005586
the investigators will exclude patients who received a level iii dissection of the axilla.
Beschrijving

Axilla Dissection Level

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004454
UMLS CUI [1,2]
C0012737
UMLS CUI [1,3]
C0441889
participants will be excluded if they are visually or hearing impaired.
Beschrijving

Visual Impairment | Hearing impairment

Datatype

boolean

Alias
UMLS CUI [1]
C3665347
UMLS CUI [2]
C1384666
although imagery can be modified for the visually or hearing impaired, that model is significantly different from an imagery program for the visual and hearing capable.
Beschrijving

Imagery therapy modified Visual Impairment | Imagery therapy modified Hearing impairment

Datatype

boolean

Alias
UMLS CUI [1,1]
C0589219
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C3665347
UMLS CUI [2,1]
C0589219
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C1384666
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Similar models

Eligibility Breast Cancer NCT01034215

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Community Dwelling Member | Age | Adult
Item
participants must be a community-dwelling member 18 years of age or older. - the participant must be at least 18 because the assessment tools are not validated for use in minors.
boolean
C4045975 (UMLS CUI [1,1])
C0680022 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
C0001675 (UMLS CUI [3])
Able to read English Language | Able to write English Language | Able to speak English Language
Item
participants should be able to read, write, and speak english.
boolean
C0586740 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0584993 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
C0564215 (UMLS CUI [3,1])
C0376245 (UMLS CUI [3,2])
Breast Carcinoma | Operative Surgical Procedures Completed | Axilla Dissection Level Absent
Item
participants must have been diagnosed with breast cancer and have completed surgery, which did not include level iii dissection of the axilla.
boolean
C0678222 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0004454 (UMLS CUI [3,1])
C0012737 (UMLS CUI [3,2])
C0441889 (UMLS CUI [3,3])
C0332197 (UMLS CUI [3,4])
Diagnosis verified Physician | Therapeutic procedure verified Physician
Item
participants must obtain verification of diagnosis and treatment from their physician.
boolean
C0011900 (UMLS CUI [1,1])
C3834725 (UMLS CUI [1,2])
C0031831 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C3834725 (UMLS CUI [2,2])
C0031831 (UMLS CUI [2,3])
Assessment Instruments Completion | Participation Data Collection Psychological | Participation Data Collection Physiological | Information Demographic Provide
Item
participants must agree to complete assessment instruments and take part in psychophysiological data gathering at baseline, 8 and 17 weeks and to provide required demographic information.
boolean
C1255665 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0679823 (UMLS CUI [2,1])
C0010995 (UMLS CUI [2,2])
C0205486 (UMLS CUI [2,3])
C0679823 (UMLS CUI [3,1])
C0010995 (UMLS CUI [3,2])
C0205463 (UMLS CUI [3,3])
C1533716 (UMLS CUI [4,1])
C0011298 (UMLS CUI [4,2])
C1999230 (UMLS CUI [4,3])
Informed Consent
Item
participants must sign informed consent, stating he/she understands the nature of the research and that he/she wishes to participate in the study. -
boolean
C0021430 (UMLS CUI [1])
Subject Diary Completion | Graph Completion | Assessment: Health Behavior
Item
participants must agree to complete the required diaries, graphs and notebooks related to behavior assessment.
boolean
C3890583 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0681493 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0549072 (UMLS CUI [3])
Comprehension Assessment procedure | Orientation to person | Orientation to place | Orientation to time
Item
participants must display the ability to understand and respond to the assessment process and must demonstrate they are oriented to person, place, and time.
boolean
C0162340 (UMLS CUI [1,1])
C1261322 (UMLS CUI [1,2])
C2371003 (UMLS CUI [2])
C2370999 (UMLS CUI [3])
C0599544 (UMLS CUI [4])
Participation Imagery therapy
Item
participants must agree to fully participate in all five imagery classes and to practice imagery skills for 20 minutes a day for 17 weeks.
boolean
C0679823 (UMLS CUI [1,1])
C0589219 (UMLS CUI [1,2])
Cancer treatment Major Completed | Operative Surgical Procedures | Therapeutic radiology procedure | Intravenous chemotherapy | Normal vision | Hearing normal
Item
participants must have completed major cancer treatment (i.e., surgery, and/or radiation and/or iv chemotherapy) for six weeks; participant must be visual and hearing capable.
boolean
C0920425 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0543467 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0413365 (UMLS CUI [4])
C0234622 (UMLS CUI [5])
C0234725 (UMLS CUI [6])
Oral chemotherapy
Item
oral chemotherapy does not preclude participation.
boolean
C0419073 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Epilepsy Uncontrolled
Item
participant will be excluded if he/she has a history of uncontrolled epileptic seizures.
boolean
C0014544 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Lacking Able to speak English Language | Lacking Able to read English Language | Lacking Able to write English Language
Item
the investigators will exclude patients who cannot speak, read and write english.
boolean
C0332268 (UMLS CUI [1,1])
C0564215 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
C0332268 (UMLS CUI [2,1])
C0586740 (UMLS CUI [2,2])
C0376245 (UMLS CUI [2,3])
C0332268 (UMLS CUI [3,1])
C0584993 (UMLS CUI [3,2])
C0376245 (UMLS CUI [3,3])
Lacking Orientation to place | Lacking Orientation to person | Lacking Orientation to time
Item
patients will be excluded if they are not oriented to place, person, and time.
boolean
C0332268 (UMLS CUI [1,1])
C2370999 (UMLS CUI [1,2])
C0332268 (UMLS CUI [2,1])
C2371003 (UMLS CUI [2,2])
C0332268 (UMLS CUI [3,1])
C0599544 (UMLS CUI [3,2])
Psychiatric Diagnosis Major | Schizophrenia | Bipolar Disorder
Item
participants will be excluded if they have a major psychiatric diagnosis (schizophrenia, bi-polar disorder).
boolean
C0376338 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0036341 (UMLS CUI [2])
C0005586 (UMLS CUI [3])
Axilla Dissection Level
Item
the investigators will exclude patients who received a level iii dissection of the axilla.
boolean
C0004454 (UMLS CUI [1,1])
C0012737 (UMLS CUI [1,2])
C0441889 (UMLS CUI [1,3])
Visual Impairment | Hearing impairment
Item
participants will be excluded if they are visually or hearing impaired.
boolean
C3665347 (UMLS CUI [1])
C1384666 (UMLS CUI [2])
Imagery therapy modified Visual Impairment | Imagery therapy modified Hearing impairment
Item
although imagery can be modified for the visually or hearing impaired, that model is significantly different from an imagery program for the visual and hearing capable.
boolean
C0589219 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C3665347 (UMLS CUI [1,3])
C0589219 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C1384666 (UMLS CUI [2,3])
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