ID

38312

Beschreibung

Group Interventions for Breast Cancer Survivors; ODM derived from: https://clinicaltrials.gov/show/NCT01775085

Link

https://clinicaltrials.gov/show/NCT01775085

Stichworte

Versionen (1)
  1. 09.10.19 09.10.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

9. Oktober 2019

DOI

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Creative Commons BY 4.0
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Eligibility Breast Cancer Survivor NCT01775085

Englisch

Eligibility Breast Cancer Survivor NCT01775085

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
history of non-metastatic breast cancer (dcis or stage i, ii, or iii) as recorded in the medical record at mskcc by self-report, or by outside correspondence, including a study checklist signed by a physician for patients outside of mskcc
Beschreibung

DCIS | Breast Carcinoma TNM Breast tumor staging

Datentyp

boolean

Alias
UMLS CUI [1]
C0007124
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0474926
>3 months post completion of treatment (may be on hormone therapy, such as tamoxifen or, herceptin) for any type of cancer as confirmed by the medical record at mskcc, by self-report, or by outside correspondence, including a study checklist signed by a physician for patients outside of mskcc
Beschreibung

Status post Cancer treatment Completion | Hormone Therapy | Tamoxifen | Herceptin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0231290
UMLS CUI [1,2]
C0920425
UMLS CUI [1,3]
C0205197
UMLS CUI [2]
C0279025
UMLS CUI [3]
C0039286
UMLS CUI [4]
C0338204
age 18 or older
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
access to a telephone, computer, and internet
Beschreibung

Access to telephone | Access Computer | Access Internet

Datentyp

boolean

Alias
UMLS CUI [1]
C1822200
UMLS CUI [2,1]
C0444454
UMLS CUI [2,2]
C0009622
UMLS CUI [3,1]
C0444454
UMLS CUI [3,2]
C0282111
for phase 2 only:
Beschreibung

Trial Phase Number

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1710475
UMLS CUI [1,2]
C0237753
a score of > or = to 4 on the distress thermometer (dt) and indication that this distress is related in some way to the patient's breast cancer or survivorship
Beschreibung

Distress Thermometer | Distress Relationship Breast Carcinoma | Distress Relationship Survivorship

Datentyp

boolean

Alias
UMLS CUI [1]
C4321507
UMLS CUI [2,1]
C0231303
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0678222
UMLS CUI [3,1]
C0231303
UMLS CUI [3,2]
C0439849
UMLS CUI [3,3]
C0038955
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, by selfreport, 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 Thoughts | Pharmaceutical Preparations Hallucinations | Sleep Disorder Agents | 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]
C4319827
UMLS CUI [5,1]
C0013227
UMLS CUI [5,2]
C0018524
UMLS CUI [6]
C4020625
UMLS CUI [7,1]
C0392747
UMLS CUI [7,2]
C2826293
UMLS CUI [7,3]
C0332268
did not participate in phase 1
Beschreibung

Participation Absent Trial Phase Number

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C1710475
UMLS CUI [1,4]
C0237753
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of or treatment metastatic disease
Beschreibung

Neoplasm Metastasis | Therapeutic procedure Neoplasm Metastasis

Datentyp

boolean

Alias
UMLS CUI [1]
C0027627
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0027627
significant psychiatric or cognitive disturbance sufficient, in the investigator's judgment, to preclude providing informed consent or participating in the groups (i.e., acute psychiatric symptoms which require individual treatment).
Beschreibung

Mental disorder Excludes Informed Consent | Impaired cognition Excludes Informed Consent | Mental disorder Excludes Participation Groups | Impaired cognition Excludes Participation Groups | Psychiatric symptom 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]
C0338656
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0021430
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C0679823
UMLS CUI [3,4]
C0441833
UMLS CUI [4,1]
C0338656
UMLS CUI [4,2]
C0332196
UMLS CUI [4,3]
C0679823
UMLS CUI [4,4]
C0441833
UMLS CUI [5,1]
C0233401
UMLS CUI [5,2]
C1514873
UMLS CUI [5,3]
C2048936
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Ähnliche Modelle

Eligibility Breast Cancer Survivor NCT01775085

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
DCIS | Breast Carcinoma TNM Breast tumor staging
Item
history of non-metastatic breast cancer (dcis or stage i, ii, or iii) as recorded in the medical record at mskcc by self-report, or by outside correspondence, including a study checklist signed by a physician for patients outside of mskcc
boolean
C0007124 (UMLS CUI [1])
C0678222 (UMLS CUI [2,1])
C0474926 (UMLS CUI [2,2])
Status post Cancer treatment Completion | Hormone Therapy | Tamoxifen | Herceptin
Item
>3 months post completion of treatment (may be on hormone therapy, such as tamoxifen or, herceptin) for any type of cancer as confirmed by the medical record at mskcc, by self-report, or by outside correspondence, including a study checklist signed by a physician for patients outside of mskcc
boolean
C0231290 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0279025 (UMLS CUI [2])
C0039286 (UMLS CUI [3])
C0338204 (UMLS CUI [4])
Age
Item
age 18 or older
boolean
C0001779 (UMLS CUI [1])
Access to telephone | Access Computer | Access Internet
Item
access to a telephone, computer, and internet
boolean
C1822200 (UMLS CUI [1])
C0444454 (UMLS CUI [2,1])
C0009622 (UMLS CUI [2,2])
C0444454 (UMLS CUI [3,1])
C0282111 (UMLS CUI [3,2])
Trial Phase Number
Item
for phase 2 only:
boolean
C1710475 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Distress Thermometer | Distress Relationship Breast Carcinoma | Distress Relationship Survivorship
Item
a score of > or = to 4 on the distress thermometer (dt) and indication that this distress is related in some way to the patient's breast cancer or survivorship
boolean
C4321507 (UMLS CUI [1])
C0231303 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0678222 (UMLS CUI [2,3])
C0231303 (UMLS CUI [3,1])
C0439849 (UMLS CUI [3,2])
C0038955 (UMLS CUI [3,3])
Mood Stabilizer | Anti-Anxiety Agents | Antidepressive Agents | Pharmaceutical Preparations Thoughts | Pharmaceutical Preparations Hallucinations | Sleep Disorder Agents | 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, by selfreport, 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])
C4319827 (UMLS CUI [4,2])
C0013227 (UMLS CUI [5,1])
C0018524 (UMLS CUI [5,2])
C4020625 (UMLS CUI [6])
C0392747 (UMLS CUI [7,1])
C2826293 (UMLS CUI [7,2])
C0332268 (UMLS CUI [7,3])
Participation Absent Trial Phase Number
Item
did not participate in phase 1
boolean
C0679823 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1710475 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Neoplasm Metastasis | Therapeutic procedure Neoplasm Metastasis
Item
evidence of or treatment metastatic disease
boolean
C0027627 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0027627 (UMLS CUI [2,2])
Mental disorder Excludes Informed Consent | Impaired cognition Excludes Informed Consent | Mental disorder Excludes Participation Groups | Impaired cognition Excludes Participation Groups | Psychiatric symptom 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 groups (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])
C0338656 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0679823 (UMLS CUI [3,3])
C0441833 (UMLS CUI [3,4])
C0338656 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C0679823 (UMLS CUI [4,3])
C0441833 (UMLS CUI [4,4])
C0233401 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C2048936 (UMLS CUI [5,3])
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