ID

38304

Beskrivning

A Home-based Physical Activity Intervention in Breast Cancer Survivors; ODM derived from: https://clinicaltrials.gov/show/NCT02408107

Länk

https://clinicaltrials.gov/show/NCT02408107

Nyckelord

Versioner (1)
  1. 2019-10-09 2019-10-09 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

9 oktober 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02408107

Engelsk

Eligibility Breast Cancer NCT02408107

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
female 18 y and over,
Beskrivning

Gender | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
diagnosed with invasive breast cancer (stage i-iii) within two years of enrolment and no evidence, or clinical suspicion, of metastatic disease,
Beskrivning

Invasive carcinoma of breast TNM Breast tumor staging | Neoplasm Metastasis Absent | Suspicion Neoplasm Metastasis Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0474926
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0242114
UMLS CUI [3,2]
C0027627
UMLS CUI [3,3]
C0332197
post-surgery and had no surgery planned for the next six months at least,
Beskrivning

Post surgery | Absence Operative Surgical Procedures Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0241311
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0543467
UMLS CUI [2,3]
C1301732
had fully completed adjuvant therapy (radiotherapy and/or chemotherapy) not including hormonal therapy,
Beskrivning

Adjuvant Radiotherapy Completed | Adjuvant Chemotherapy Completed | Exception Hormone Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0242939
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0085533
UMLS CUI [2,2]
C0205197
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0279025
no previous malignancy except in the case of ductal carcinoma in situ (dcis), lobular carcinoma in situ (lcis), basal cell carcinoma or cervical carcinoma in situ, or where the patient has been disease−free for 10 years,
Beskrivning

Malignant Neoplasms Previous Absent | Exception DCIS | Exception Lobular carcinoma in situ of breast | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Disease Free Duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007124
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0279563
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007117
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0851140
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0012634
UMLS CUI [6,3]
C0332296
UMLS CUI [6,4]
C0449238
no concomitant medical or psychiatric problems that might prevent completion of treatment or follow−up,
Beskrivning

Absence Medical Problem Preventing Treatment completion | Absence Mental problem Preventing Treatment completion | Absence Medical Problem Preventing Follow-up | Absence Mental problem Preventing Follow-up

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1254481
UMLS CUI [1,3]
C1292733
UMLS CUI [1,4]
C0580352
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0848067
UMLS CUI [2,3]
C1292733
UMLS CUI [2,4]
C0580352
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C1254481
UMLS CUI [3,3]
C1292733
UMLS CUI [3,4]
C3274571
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C0848067
UMLS CUI [4,3]
C1292733
UMLS CUI [4,4]
C3274571
willing to be randomised, and willing to maintain contact with the investigators over the six months
Beskrivning

Randomization Willing | Maintenance Contact with Research Personnel

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0600109
UMLS CUI [2,1]
C0024501
UMLS CUI [2,2]
C0332158
UMLS CUI [2,3]
C0035173
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
no evidence of invasive breast cancer (i.e. only pre−invasive disease identified),
Beskrivning

Invasive carcinoma of breast Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0332197
previous invasive breast cancer (surgically treated dcis or lcis is allowed),
Beskrivning

Invasive carcinoma of breast Previous | Operative Surgical Procedures DCIS allowed | Operative Surgical Procedures Lobular carcinoma in situ of breast allowed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0007124
UMLS CUI [2,3]
C0683607
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C0279563
UMLS CUI [3,3]
C0683607
inability to participate in pa because of severe disability (e.g. severe arthritic conditions), psychiatric illness and vulnerable subjects, such as pregnant women.
Beskrivning

Participation Physical activity Unable | Disability - severe | Arthritis Severe | Mental disorders | Vulnerable Populations | Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0026606
UMLS CUI [1,3]
C1299582
UMLS CUI [2]
C0424990
UMLS CUI [3,1]
C0003864
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0004936
UMLS CUI [5]
C0949366
UMLS CUI [6]
C0032961
any other patient where pa was not approved by their oncologist due to the presence of one or more contraindications to exercise in cancer patients.
Beskrivning

Lacking Approval Physical activity | Medical contraindication Exercise

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0205540
UMLS CUI [1,3]
C0026606
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0015259
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Similar models

Eligibility Breast Cancer NCT02408107

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
female 18 y and over,
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Invasive carcinoma of breast TNM Breast tumor staging | Neoplasm Metastasis Absent | Suspicion Neoplasm Metastasis Absent
Item
diagnosed with invasive breast cancer (stage i-iii) within two years of enrolment and no evidence, or clinical suspicion, of metastatic disease,
boolean
C0853879 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0242114 (UMLS CUI [3,1])
C0027627 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Post surgery | Absence Operative Surgical Procedures Planned
Item
post-surgery and had no surgery planned for the next six months at least,
boolean
C0241311 (UMLS CUI [1])
C0332197 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
Adjuvant Radiotherapy Completed | Adjuvant Chemotherapy Completed | Exception Hormone Therapy
Item
had fully completed adjuvant therapy (radiotherapy and/or chemotherapy) not including hormonal therapy,
boolean
C0242939 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0085533 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0279025 (UMLS CUI [3,2])
Malignant Neoplasms Previous Absent | Exception DCIS | Exception Lobular carcinoma in situ of breast | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Disease Free Duration
Item
no previous malignancy except in the case of ductal carcinoma in situ (dcis), lobular carcinoma in situ (lcis), basal cell carcinoma or cervical carcinoma in situ, or where the patient has been disease−free for 10 years,
boolean
C0006826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0007124 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0279563 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0851140 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0012634 (UMLS CUI [6,2])
C0332296 (UMLS CUI [6,3])
C0449238 (UMLS CUI [6,4])
Absence Medical Problem Preventing Treatment completion | Absence Mental problem Preventing Treatment completion | Absence Medical Problem Preventing Follow-up | Absence Mental problem Preventing Follow-up
Item
no concomitant medical or psychiatric problems that might prevent completion of treatment or follow−up,
boolean
C0332197 (UMLS CUI [1,1])
C1254481 (UMLS CUI [1,2])
C1292733 (UMLS CUI [1,3])
C0580352 (UMLS CUI [1,4])
C0332197 (UMLS CUI [2,1])
C0848067 (UMLS CUI [2,2])
C1292733 (UMLS CUI [2,3])
C0580352 (UMLS CUI [2,4])
C0332197 (UMLS CUI [3,1])
C1254481 (UMLS CUI [3,2])
C1292733 (UMLS CUI [3,3])
C3274571 (UMLS CUI [3,4])
C0332197 (UMLS CUI [4,1])
C0848067 (UMLS CUI [4,2])
C1292733 (UMLS CUI [4,3])
C3274571 (UMLS CUI [4,4])
Randomization Willing | Maintenance Contact with Research Personnel
Item
willing to be randomised, and willing to maintain contact with the investigators over the six months
boolean
C0034656 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0024501 (UMLS CUI [2,1])
C0332158 (UMLS CUI [2,2])
C0035173 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Invasive carcinoma of breast Absent
Item
no evidence of invasive breast cancer (i.e. only pre−invasive disease identified),
boolean
C0853879 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Invasive carcinoma of breast Previous | Operative Surgical Procedures DCIS allowed | Operative Surgical Procedures Lobular carcinoma in situ of breast allowed
Item
previous invasive breast cancer (surgically treated dcis or lcis is allowed),
boolean
C0853879 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C0007124 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
C0543467 (UMLS CUI [3,1])
C0279563 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
Participation Physical activity Unable | Disability - severe | Arthritis Severe | Mental disorders | Vulnerable Populations | Pregnancy
Item
inability to participate in pa because of severe disability (e.g. severe arthritic conditions), psychiatric illness and vulnerable subjects, such as pregnant women.
boolean
C0679823 (UMLS CUI [1,1])
C0026606 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0424990 (UMLS CUI [2])
C0003864 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0004936 (UMLS CUI [4])
C0949366 (UMLS CUI [5])
C0032961 (UMLS CUI [6])
Lacking Approval Physical activity | Medical contraindication Exercise
Item
any other patient where pa was not approved by their oncologist due to the presence of one or more contraindications to exercise in cancer patients.
boolean
C0332268 (UMLS CUI [1,1])
C0205540 (UMLS CUI [1,2])
C0026606 (UMLS CUI [1,3])
C1301624 (UMLS CUI [2,1])
C0015259 (UMLS CUI [2,2])
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