ID

37948

Description

Comparing (SIS.NET) to Standard Care in Patients Who Have Completed the Acute Phase of Treatment for Early Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01308775

Lien

https://clinicaltrials.gov/show/NCT01308775

Mots-clés

Versions (1)
  1. 02/09/2019 02/09/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

2 septembre 2019

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01308775

Anglais

Eligibility Breast Cancer NCT01308775

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients diagnosed with stage i to stage iii breast cancer that have completed their acute phase of treatment. (this includes surgery, radiation, chemotherapy, or any experimental therapies offered in a clinical trial as adjuvant treatment.)
Description

Breast Carcinoma TNM Breast tumor staging | Treatment completed | Operative Surgical Procedure | Therapeutic radiology procedure | Chemotherapy | Investigational Therapies Adjuvant

Type de données

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0474926
UMLS CUI [2]
C0580352
UMLS CUI [3]
C0543467
UMLS CUI [4]
C1522449
UMLS CUI [5]
C0392920
UMLS CUI [6,1]
C0949266
UMLS CUI [6,2]
C1522673
patients who received chemotherapy must be 6 months out from completion of chemotherapy.
Description

Chemotherapy Completed

Type de données

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0205197
for patients who receive adjuvant hormonal therapy (with or without prior chemotherapy), patients must be 3 months out from initiation of hormonal therapy.
Description

Hormone Therapy Adjuvant | In addition to Prior Chemotherapy | Prior Chemotherapy Absent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C1522673
UMLS CUI [2,1]
C0332287
UMLS CUI [2,2]
C1514457
UMLS CUI [3,1]
C1514457
UMLS CUI [3,2]
C0332197
for patients who do not receive adjuvant chemotherapy or hormonal therapy, patients must be 3 months out from surgery and radiation therapy.
Description

Adjuvant Chemotherapy Absent | Hormone Therapy Adjuvant Absent | Operative Surgical Procedure Completed | Therapeutic radiology procedure Completed

Type de données

boolean

Alias
UMLS CUI [1,1]
C0085533
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C1522673
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C0205197
UMLS CUI [4,1]
C1522449
UMLS CUI [4,2]
C0205197
2. patients must have recovered from all serious side effects of acute phase of treatment for breast cancer.
Description

Treatment Breast Carcinoma | Side effects Serious | Patient recovered

Type de données

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C0879626
UMLS CUI [2,2]
C0205404
UMLS CUI [3]
C1115804
3. patients must be willing to complete symptom reporting questionnaires at the intervals assigned by their care group.
Description

Symptom Reporting Questionnaires Completion

Type de données

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0700287
UMLS CUI [1,3]
C0034394
UMLS CUI [1,4]
C0205197
4. patients must have hematologic, cardiac, hepatic, and renal function that are back to their pre-treatment values.
Description

Hematologic function Pre treatment Laboratory Results | Cardiac function Pre treatment Laboratory Results | Liver function Pre treatment Laboratory Results | Renal function Pre treatment Laboratory Results

Type de données

boolean

Alias
UMLS CUI [1,1]
C0221130
UMLS CUI [1,2]
C2709094
UMLS CUI [1,3]
C1254595
UMLS CUI [2,1]
C0232164
UMLS CUI [2,2]
C2709094
UMLS CUI [2,3]
C1254595
UMLS CUI [3,1]
C0232741
UMLS CUI [3,2]
C2709094
UMLS CUI [3,3]
C1254595
UMLS CUI [4,1]
C0232804
UMLS CUI [4,2]
C2709094
UMLS CUI [4,3]
C1254595
5. patient must be able to read and speak english sufficiently to complete symptom reporting questionnaires and discuss details of symptoms and health status over the telephone.
Description

Able to read English Language | Able to speak English Language | Symptom Reporting Questionnaires Completion

Type de données

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0564215
UMLS CUI [2,2]
C0376245
UMLS CUI [3,1]
C1457887
UMLS CUI [3,2]
C0700287
UMLS CUI [3,3]
C0034394
UMLS CUI [3,4]
C0205197
6. patient must have access to a computer on which to complete the on-line surveys or must be willing to come to the ucsf cancer resource center to complete questionnaires at the intervals assigned by their care group.
Description

Access Computer | Questionnaires Completion

Type de données

boolean

Alias
UMLS CUI [1,1]
C0444454
UMLS CUI [1,2]
C0009622
UMLS CUI [2,1]
C0034394
UMLS CUI [2,2]
C0205197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. history of severe depression or an anxiety disorder that is felt to interfere with a patient's ability to accurately self-report symptoms.
Description

Severe depression Interferes with Patient Self-Report Symptoms | Anxiety Disorder Interferes with Patient Self-Report Symptoms

Type de données

boolean

Alias
UMLS CUI [1,1]
C0588008
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0681906
UMLS CUI [1,4]
C1457887
UMLS CUI [2,1]
C0003469
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0681906
UMLS CUI [2,4]
C1457887
2. complications from breast surgery or reconstruction, or from chemotherapy or radiation that may require regular ongoing clinic visits for physical and/or laboratory evaluation.
Description

Complications Resulting from Operation on breast | Complications Resulting from Mammaplasty | Requirement Clinic Visits Regular

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C3714726
UMLS CUI [2,1]
C0009566
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0085076
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0008952
UMLS CUI [3,3]
C0205272
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Similar models

Eligibility Breast Cancer NCT01308775

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma TNM Breast tumor staging | Treatment completed | Operative Surgical Procedure | Therapeutic radiology procedure | Chemotherapy | Investigational Therapies Adjuvant
Item
1. patients diagnosed with stage i to stage iii breast cancer that have completed their acute phase of treatment. (this includes surgery, radiation, chemotherapy, or any experimental therapies offered in a clinical trial as adjuvant treatment.)
boolean
C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0580352 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
C0392920 (UMLS CUI [5])
C0949266 (UMLS CUI [6,1])
C1522673 (UMLS CUI [6,2])
Chemotherapy Completed
Item
patients who received chemotherapy must be 6 months out from completion of chemotherapy.
boolean
C0392920 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Hormone Therapy Adjuvant | In addition to Prior Chemotherapy | Prior Chemotherapy Absent
Item
for patients who receive adjuvant hormonal therapy (with or without prior chemotherapy), patients must be 3 months out from initiation of hormonal therapy.
boolean
C0279025 (UMLS CUI [1,1])
C1522673 (UMLS CUI [1,2])
C0332287 (UMLS CUI [2,1])
C1514457 (UMLS CUI [2,2])
C1514457 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Adjuvant Chemotherapy Absent | Hormone Therapy Adjuvant Absent | Operative Surgical Procedure Completed | Therapeutic radiology procedure Completed
Item
for patients who do not receive adjuvant chemotherapy or hormonal therapy, patients must be 3 months out from surgery and radiation therapy.
boolean
C0085533 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2,1])
C1522673 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0543467 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
C1522449 (UMLS CUI [4,1])
C0205197 (UMLS CUI [4,2])
Treatment Breast Carcinoma | Side effects Serious | Patient recovered
Item
2. patients must have recovered from all serious side effects of acute phase of treatment for breast cancer.
boolean
C0087111 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0879626 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C1115804 (UMLS CUI [3])
Symptom Reporting Questionnaires Completion
Item
3. patients must be willing to complete symptom reporting questionnaires at the intervals assigned by their care group.
boolean
C1457887 (UMLS CUI [1,1])
C0700287 (UMLS CUI [1,2])
C0034394 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,4])
Hematologic function Pre treatment Laboratory Results | Cardiac function Pre treatment Laboratory Results | Liver function Pre treatment Laboratory Results | Renal function Pre treatment Laboratory Results
Item
4. patients must have hematologic, cardiac, hepatic, and renal function that are back to their pre-treatment values.
boolean
C0221130 (UMLS CUI [1,1])
C2709094 (UMLS CUI [1,2])
C1254595 (UMLS CUI [1,3])
C0232164 (UMLS CUI [2,1])
C2709094 (UMLS CUI [2,2])
C1254595 (UMLS CUI [2,3])
C0232741 (UMLS CUI [3,1])
C2709094 (UMLS CUI [3,2])
C1254595 (UMLS CUI [3,3])
C0232804 (UMLS CUI [4,1])
C2709094 (UMLS CUI [4,2])
C1254595 (UMLS CUI [4,3])
Able to read English Language | Able to speak English Language | Symptom Reporting Questionnaires Completion
Item
5. patient must be able to read and speak english sufficiently to complete symptom reporting questionnaires and discuss details of symptoms and health status over the telephone.
boolean
C0586740 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0564215 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
C1457887 (UMLS CUI [3,1])
C0700287 (UMLS CUI [3,2])
C0034394 (UMLS CUI [3,3])
C0205197 (UMLS CUI [3,4])
Access Computer | Questionnaires Completion
Item
6. patient must have access to a computer on which to complete the on-line surveys or must be willing to come to the ucsf cancer resource center to complete questionnaires at the intervals assigned by their care group.
boolean
C0444454 (UMLS CUI [1,1])
C0009622 (UMLS CUI [1,2])
C0034394 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Severe depression Interferes with Patient Self-Report Symptoms | Anxiety Disorder Interferes with Patient Self-Report Symptoms
Item
1. history of severe depression or an anxiety disorder that is felt to interfere with a patient's ability to accurately self-report symptoms.
boolean
C0588008 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0681906 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
C0003469 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0681906 (UMLS CUI [2,3])
C1457887 (UMLS CUI [2,4])
Complications Resulting from Operation on breast | Complications Resulting from Mammaplasty | Requirement Clinic Visits Regular
Item
2. complications from breast surgery or reconstruction, or from chemotherapy or radiation that may require regular ongoing clinic visits for physical and/or laboratory evaluation.
boolean
C0009566 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C3714726 (UMLS CUI [1,3])
C0009566 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0085076 (UMLS CUI [2,3])
C1514873 (UMLS CUI [3,1])
C0008952 (UMLS CUI [3,2])
C0205272 (UMLS CUI [3,3])
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