ID

37811

Beschreibung

Enhancing Physical Activity Adherence After Breast Cancer Diagnosis (BEAT Cancer II); ODM derived from: https://clinicaltrials.gov/show/NCT00929617

Link

https://clinicaltrials.gov/show/NCT00929617

Stichworte

Versionen (1)
  1. 25.08.19 25.08.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

25. August 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00929617

Englisch

Eligibility Breast Cancer NCT00929617

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
female breast cancer patients between the ages of 18 and 70 years of age with a diagnosis of ductal carcinoma in situ (dcis) or stage i, ii, or iiia breast cancer and who are not currently receiving (and do not plan to receive during the duration of the study) chemotherapy or radiation therapy. the participant may be taking longer term therapies such as aromatase inhibitors, estrogen receptor modulators, etc. the upper age limit of 70 years was chosen to reduce the likelihood of adverse events or study drop-out due to increasing comorbidities (e.g., cardiovascular disease) that occur with age.
Beschreibung

Gender | Breast Carcinoma | Age | Noninfiltrating Intraductal Carcinoma | Breast Carcinoma TNM Breast tumor staging | Chemotherapy Absent | Therapeutic radiology procedure Absent | Therapeutic procedure Long-term | Aromatase Inhibitors | Estrogen Receptor Modulators | Cardiovascular Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0678222
UMLS CUI [3]
C0001779
UMLS CUI [4]
C0007124
UMLS CUI [5,1]
C0678222
UMLS CUI [5,2]
C0474926
UMLS CUI [6,1]
C0392920
UMLS CUI [6,2]
C0332197
UMLS CUI [7,1]
C1522449
UMLS CUI [7,2]
C0332197
UMLS CUI [8,1]
C0087111
UMLS CUI [8,2]
C0443252
UMLS CUI [9]
C0593802
UMLS CUI [10]
C0752229
UMLS CUI [11]
C0007222
if the patient has undergone a surgical procedure, enrollment will be delayed until ≥
Beschreibung

Operative Surgical Procedures | Enrollment Delayed

Datentyp

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2,1]
C1516879
UMLS CUI [2,2]
C0205421
8 weeks post-procedure.
Beschreibung

Enrollment Post Procedure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0184661
english speaking.
Beschreibung

Able to speak English Language

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
medical clearance for participation provided by primary care physician or oncologist.
Beschreibung

Study Subject Participation Status Approved Primary Care Physician | Study Subject Participation Status Approved Oncologist

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0205540
UMLS CUI [1,3]
C0033131
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C0205540
UMLS CUI [2,3]
C0259990
participating, on average, in no more than 60 minutes of moderate physical activity or no more than 30 minutes of vigorous activity per week during the past six months.
Beschreibung

Moderate physical activity minutes per week | Vigorous physical activity minutes per week

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4482418
UMLS CUI [1,2]
C0556975
UMLS CUI [2,1]
C4267713
UMLS CUI [2,2]
C0556975
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
diagnosis of dementia or organic brain syndrome.
Beschreibung

Dementia | Organic brain syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C0497327
UMLS CUI [2]
C0029221
medical, psychological, or social characteristic that would interfere with ability to fully participate in program activities and assessments (e.g., psychosis, schizophrenia, etc.).
Beschreibung

Characteristics Medical Interfere with Study Protocol | Characteristics Psychological Interfere with Study Protocol | Characteristics social Interfere with Study Protocol | Psychotic Disorders | Schizophrenia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1521970
UMLS CUI [1,2]
C0205476
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C2348563
UMLS CUI [2,1]
C1521970
UMLS CUI [2,2]
C0205486
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C2348563
UMLS CUI [3,1]
C1521970
UMLS CUI [3,2]
C0728831
UMLS CUI [3,3]
C0521102
UMLS CUI [3,4]
C2348563
UMLS CUI [4]
C0033975
UMLS CUI [5]
C0036341
contraindication to participation in a regular physical activity program.
Beschreibung

Medical contraindication Physical activity Regular

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0026606
UMLS CUI [1,3]
C0205272
metastatic or recurrent disease.
Beschreibung

Neoplasm Metastasis | Recurrent disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0027627
UMLS CUI [2]
C0277556
inability to ambulate.
Beschreibung

Lacking Able to walk

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712089
anticipates undergoing elective surgery during the duration of the intervention which would interfere with intervention participation (e.g., breast reconstructive surgery).
Beschreibung

Elective Surgical Procedure Interferes with Intervention | Reconstructive breast surgery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0206058
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0184661
UMLS CUI [2]
C1408823
planned travel that would interfere with scheduled study sessions (no travel in the 1st 4 months and no travel ≥ 1 week in the last 8 weeks of the intervention).
Beschreibung

Travel Interferes with Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0040802
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348563
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Ähnliche Modelle

Eligibility Breast Cancer NCT00929617

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Breast Carcinoma | Age | Noninfiltrating Intraductal Carcinoma | Breast Carcinoma TNM Breast tumor staging | Chemotherapy Absent | Therapeutic radiology procedure Absent | Therapeutic procedure Long-term | Aromatase Inhibitors | Estrogen Receptor Modulators | Cardiovascular Disease
Item
female breast cancer patients between the ages of 18 and 70 years of age with a diagnosis of ductal carcinoma in situ (dcis) or stage i, ii, or iiia breast cancer and who are not currently receiving (and do not plan to receive during the duration of the study) chemotherapy or radiation therapy. the participant may be taking longer term therapies such as aromatase inhibitors, estrogen receptor modulators, etc. the upper age limit of 70 years was chosen to reduce the likelihood of adverse events or study drop-out due to increasing comorbidities (e.g., cardiovascular disease) that occur with age.
boolean
C0079399 (UMLS CUI [1])
C0678222 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0007124 (UMLS CUI [4])
C0678222 (UMLS CUI [5,1])
C0474926 (UMLS CUI [5,2])
C0392920 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C1522449 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
C0087111 (UMLS CUI [8,1])
C0443252 (UMLS CUI [8,2])
C0593802 (UMLS CUI [9])
C0752229 (UMLS CUI [10])
C0007222 (UMLS CUI [11])
Operative Surgical Procedures | Enrollment Delayed
Item
if the patient has undergone a surgical procedure, enrollment will be delayed until ≥
boolean
C0543467 (UMLS CUI [1])
C1516879 (UMLS CUI [2,1])
C0205421 (UMLS CUI [2,2])
Enrollment Post Procedure
Item
8 weeks post-procedure.
boolean
C1516879 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])
Able to speak English Language
Item
english speaking.
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
Study Subject Participation Status Approved Primary Care Physician | Study Subject Participation Status Approved Oncologist
Item
medical clearance for participation provided by primary care physician or oncologist.
boolean
C2348568 (UMLS CUI [1,1])
C0205540 (UMLS CUI [1,2])
C0033131 (UMLS CUI [1,3])
C2348568 (UMLS CUI [2,1])
C0205540 (UMLS CUI [2,2])
C0259990 (UMLS CUI [2,3])
Moderate physical activity minutes per week | Vigorous physical activity minutes per week
Item
participating, on average, in no more than 60 minutes of moderate physical activity or no more than 30 minutes of vigorous activity per week during the past six months.
boolean
C4482418 (UMLS CUI [1,1])
C0556975 (UMLS CUI [1,2])
C4267713 (UMLS CUI [2,1])
C0556975 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Dementia | Organic brain syndrome
Item
diagnosis of dementia or organic brain syndrome.
boolean
C0497327 (UMLS CUI [1])
C0029221 (UMLS CUI [2])
Characteristics Medical Interfere with Study Protocol | Characteristics Psychological Interfere with Study Protocol | Characteristics social Interfere with Study Protocol | Psychotic Disorders | Schizophrenia
Item
medical, psychological, or social characteristic that would interfere with ability to fully participate in program activities and assessments (e.g., psychosis, schizophrenia, etc.).
boolean
C1521970 (UMLS CUI [1,1])
C0205476 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
C1521970 (UMLS CUI [2,1])
C0205486 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C2348563 (UMLS CUI [2,4])
C1521970 (UMLS CUI [3,1])
C0728831 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C2348563 (UMLS CUI [3,4])
C0033975 (UMLS CUI [4])
C0036341 (UMLS CUI [5])
Medical contraindication Physical activity Regular
Item
contraindication to participation in a regular physical activity program.
boolean
C1301624 (UMLS CUI [1,1])
C0026606 (UMLS CUI [1,2])
C0205272 (UMLS CUI [1,3])
Neoplasm Metastasis | Recurrent disease
Item
metastatic or recurrent disease.
boolean
C0027627 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
Lacking Able to walk
Item
inability to ambulate.
boolean
C0332268 (UMLS CUI [1,1])
C2712089 (UMLS CUI [1,2])
Elective Surgical Procedure Interferes with Intervention | Reconstructive breast surgery
Item
anticipates undergoing elective surgery during the duration of the intervention which would interfere with intervention participation (e.g., breast reconstructive surgery).
boolean
C0206058 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])
C1408823 (UMLS CUI [2])
Travel Interferes with Study Protocol
Item
planned travel that would interfere with scheduled study sessions (no travel in the 1st 4 months and no travel ≥ 1 week in the last 8 weeks of the intervention).
boolean
C0040802 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
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