ID

38059

Beschreibung

Attention and Interpretation Modification (AIM) for Fear of Breast Cancer Recurrence: An Intervention Development Study; ODM derived from: https://clinicaltrials.gov/show/NCT01517945

Link

https://clinicaltrials.gov/show/NCT01517945

Stichworte

Versionen (1)
  1. 13.09.19 13.09.19 -
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See clinicaltrials.gov

Hochgeladen am

13. September 2019

DOI

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Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01517945

Englisch

Eligibility Breast Cancer NCT01517945

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
breast cancer survivors
Beschreibung

Breast Carcinoma Survivors

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0206194
hx of early-stage breast cancer (dcis and stages i, ii and iii)as recorded in the medical record at mskcc or by self-report or by outside correspondence, including a study checklist signed by a physician for patients outside of mskcc.
Beschreibung

Early-Stage Breast Carcinoma TNM Breast tumor staging | DCIS

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2986665
UMLS CUI [1,2]
C0474926
UMLS CUI [2]
C0007124
≥ 3 months post completion of breast cancer treatment (may be on hormone therapy, such as tamoxifen) with no history of recurrence or metastasis as confirmed by the medical record at mskcc, self- report or by outside correspondence
Beschreibung

Treatment completed Breast Carcinoma | Hormone Therapy | Tamoxifen | Recurrence Absent | Neoplasm Metastasis Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0580352
UMLS CUI [1,2]
C0678222
UMLS CUI [2]
C0279025
UMLS CUI [3]
C0039286
UMLS CUI [4,1]
C0034897
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0027627
UMLS CUI [5,2]
C0332197
age 18 or older
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
able to read and speak english
Beschreibung

Able to read English Language | Able to speak English Language

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0564215
UMLS CUI [2,2]
C0376245
an overall fear index score of ≥ 3.0 on the cars
Beschreibung

Fear Index Score | Other Coding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015726
UMLS CUI [1,2]
C0918012
UMLS CUI [1,3]
C0449820
UMLS CUI [2]
C3846158
if taking medication for mood, anxiety, depression, thoughts, sensory experiences such as hallucinations, or sleep, stable and consistent enough in dosage and use of that medication so as to not result in a clinically significant change as determined by the study pi/co-pi or confirmed by reports in the medical record at mskcc or by self-report or by outside correspondence, including a study checklist signed by a physician for patients outside of mskcc
Beschreibung

Mood Stabilizer | Anti-Anxiety Agents | Antidepressive Agents | Pharmaceutical Preparations Hallucinations | Sleeping pill | Pharmaceutical Preparations Dosage Stable | Change Clinical Significance Lacking

Datentyp

boolean

Alias
UMLS CUI [1]
C2917435
UMLS CUI [2]
C0040616
UMLS CUI [3]
C0003289
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C0018524
UMLS CUI [5]
C0599396
UMLS CUI [6,1]
C0013227
UMLS CUI [6,2]
C0178602
UMLS CUI [6,3]
C0205360
UMLS CUI [7,1]
C0392747
UMLS CUI [7,2]
C2826293
UMLS CUI [7,3]
C0332268
if in non-cbt psychotherapy, stable for at least 8 weeks
Beschreibung

Psychotherapy Stable | Exception Cognitive Therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0033968
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0009244
access to a computer or willingness to come to mskcc to complete intervention sessions 2-8 and the 3-month follow-up assessment, if no personal computer.
Beschreibung

Access Computer | Intervention Completion | Follow-up Assessment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0444454
UMLS CUI [1,2]
C0009622
UMLS CUI [2,1]
C0184661
UMLS CUI [2,2]
C0205197
UMLS CUI [3,1]
C3274571
UMLS CUI [3,2]
C1516048
for part 2 only, did not participate in part 1
Beschreibung

Clinical Trial Part Number

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0449719
UMLS CUI [1,3]
C0237753
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of or treatment for a second primary of cancer except basal or squamous cell carcinoma of the skin as confirmed by the medical record at mskcc, by self-report, or by outside correspondence
Beschreibung

Second Primary Cancer | Therapeutic procedure Second Primary Cancer | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin

Datentyp

boolean

Alias
UMLS CUI [1]
C0751623
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0751623
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
significant psychiatric or cognitive disturbance sufficient, in the investigator's judgment, to preclude providing informed consent or participating in the interventions (i.e., acute psychiatric symptoms which require individual treatment).
Beschreibung

Mental disorder Excludes Informed Consent | Mental disorder Excludes Participation Intervention | Impaired cognition Excludes Informed Consent | Impaired cognition Excludes Participation Intervention | Psychiatric symptoms Requirement Individual psychiatric therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0679823
UMLS CUI [2,4]
C0184661
UMLS CUI [3,1]
C0338656
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C0021430
UMLS CUI [4,1]
C0338656
UMLS CUI [4,2]
C0332196
UMLS CUI [4,3]
C0679823
UMLS CUI [4,4]
C0184661
UMLS CUI [5,1]
C0233401
UMLS CUI [5,2]
C1514873
UMLS CUI [5,3]
C2048936
current participation in cognitive-behavioral therapy (cbt), as confirmed by either self-report* or the medical record which also targets cognitive biases.
Beschreibung

Participation Cognitive Therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0009244
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Ähnliche Modelle

Eligibility Breast Cancer NCT01517945

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma Survivors
Item
breast cancer survivors
boolean
C0678222 (UMLS CUI [1,1])
C0206194 (UMLS CUI [1,2])
Early-Stage Breast Carcinoma TNM Breast tumor staging | DCIS
Item
hx of early-stage breast cancer (dcis and stages i, ii and iii)as recorded in the medical record at mskcc or by self-report or by outside correspondence, including a study checklist signed by a physician for patients outside of mskcc.
boolean
C2986665 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0007124 (UMLS CUI [2])
Treatment completed Breast Carcinoma | Hormone Therapy | Tamoxifen | Recurrence Absent | Neoplasm Metastasis Absent
Item
≥ 3 months post completion of breast cancer treatment (may be on hormone therapy, such as tamoxifen) with no history of recurrence or metastasis as confirmed by the medical record at mskcc, self- report or by outside correspondence
boolean
C0580352 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2])
C0039286 (UMLS CUI [3])
C0034897 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0027627 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Age
Item
age 18 or older
boolean
C0001779 (UMLS CUI [1])
Able to read English Language | Able to speak English Language
Item
able to read and speak english
boolean
C0586740 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0564215 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
Fear Index Score | Other Coding
Item
an overall fear index score of ≥ 3.0 on the cars
boolean
C0015726 (UMLS CUI [1,1])
C0918012 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
C3846158 (UMLS CUI [2])
Mood Stabilizer | Anti-Anxiety Agents | Antidepressive Agents | Pharmaceutical Preparations Hallucinations | Sleeping pill | Pharmaceutical Preparations Dosage Stable | Change Clinical Significance Lacking
Item
if taking medication for mood, anxiety, depression, thoughts, sensory experiences such as hallucinations, or sleep, stable and consistent enough in dosage and use of that medication so as to not result in a clinically significant change as determined by the study pi/co-pi or confirmed by reports in the medical record at mskcc or by self-report or by outside correspondence, including a study checklist signed by a physician for patients outside of mskcc
boolean
C2917435 (UMLS CUI [1])
C0040616 (UMLS CUI [2])
C0003289 (UMLS CUI [3])
C0013227 (UMLS CUI [4,1])
C0018524 (UMLS CUI [4,2])
C0599396 (UMLS CUI [5])
C0013227 (UMLS CUI [6,1])
C0178602 (UMLS CUI [6,2])
C0205360 (UMLS CUI [6,3])
C0392747 (UMLS CUI [7,1])
C2826293 (UMLS CUI [7,2])
C0332268 (UMLS CUI [7,3])
Psychotherapy Stable | Exception Cognitive Therapy
Item
if in non-cbt psychotherapy, stable for at least 8 weeks
boolean
C0033968 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0009244 (UMLS CUI [2,2])
Access Computer | Intervention Completion | Follow-up Assessment
Item
access to a computer or willingness to come to mskcc to complete intervention sessions 2-8 and the 3-month follow-up assessment, if no personal computer.
boolean
C0444454 (UMLS CUI [1,1])
C0009622 (UMLS CUI [1,2])
C0184661 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C3274571 (UMLS CUI [3,1])
C1516048 (UMLS CUI [3,2])
Clinical Trial Part Number
Item
for part 2 only, did not participate in part 1
boolean
C0008976 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Second Primary Cancer | Therapeutic procedure Second Primary Cancer | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin
Item
evidence of or treatment for a second primary of cancer except basal or squamous cell carcinoma of the skin as confirmed by the medical record at mskcc, by self-report, or by outside correspondence
boolean
C0751623 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0751623 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
Mental disorder Excludes Informed Consent | Mental disorder Excludes Participation Intervention | Impaired cognition Excludes Informed Consent | Impaired cognition Excludes Participation Intervention | Psychiatric symptoms Requirement Individual psychiatric therapy
Item
significant psychiatric or cognitive disturbance sufficient, in the investigator's judgment, to preclude providing informed consent or participating in the interventions (i.e., acute psychiatric symptoms which require individual treatment).
boolean
C0004936 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0679823 (UMLS CUI [2,3])
C0184661 (UMLS CUI [2,4])
C0338656 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
C0338656 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C0679823 (UMLS CUI [4,3])
C0184661 (UMLS CUI [4,4])
C0233401 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C2048936 (UMLS CUI [5,3])
Participation Cognitive Therapy
Item
current participation in cognitive-behavioral therapy (cbt), as confirmed by either self-report* or the medical record which also targets cognitive biases.
boolean
C0679823 (UMLS CUI [1,1])
C0009244 (UMLS CUI [1,2])
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