ID

38043

Beskrivning

S1105: Text-Messaging Intervention to Reduce Early Discontinuation of AI Therapy in Women With Early-Stage Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01515800

Länk

https://clinicaltrials.gov/show/NCT01515800

Nyckelord

Versioner (1)
  1. 2019-09-11 2019-09-11 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

11 september 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01515800

Engelsk

Eligibility Breast Cancer NCT01515800

1 Formulär  
Criteria
Beskrivning

Criteria

patients must be women with a diagnosis of histologically confirmed, primary invasive, hormone-sensitive (estrogen receptor-positive [er]/progesterone receptor [pr]-positive) adenocarcinoma of the breast (stage i, ii or iii) with no evidence of recurrent or metastatic disease (m0)
Beskrivning

Gender | Breast adenocarcinoma Invasive TNM Breast tumor staging | Breast adenocarcinoma Invasive Hormone-sensitive | Breast adenocarcinoma Invasive Estrogen receptor positive | Breast adenocarcinoma Invasive Progesterone receptor positive | Recurrent disease Absent | Neoplasm Metastasis Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0858252
UMLS CUI [2,2]
C0205281
UMLS CUI [2,3]
C0474926
UMLS CUI [3,1]
C0858252
UMLS CUI [3,2]
C0205281
UMLS CUI [3,3]
C1512498
UMLS CUI [4,1]
C0858252
UMLS CUI [4,2]
C0205281
UMLS CUI [4,3]
C0279754
UMLS CUI [5,1]
C0858252
UMLS CUI [5,2]
C0205281
UMLS CUI [5,3]
C0279759
UMLS CUI [6,1]
C0277556
UMLS CUI [6,2]
C0332197
UMLS CUI [7,1]
C0027627
UMLS CUI [7,2]
C0332197
patients must have a mobile phone that can receive text messages and must currently use or be willing to learn to use text messaging
Beskrivning

Availability of Mobile Phone | Mobile Phone Receive Text Messages | Use of Text Messaging | Learning Text Messaging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C1136360
UMLS CUI [2,1]
C1136360
UMLS CUI [2,2]
C1514756
UMLS CUI [2,3]
C3178910
UMLS CUI [3,1]
C1524063
UMLS CUI [3,2]
C3178908
UMLS CUI [4,1]
C0023185
UMLS CUI [4,2]
C3178908
patient characteristics:
Beskrivning

Client Characteristics

Datatyp

boolean

Alias
UMLS CUI [1]
C0815172
patients must be postmenopausal, as defined by at least one of the following:
Beskrivning

Postmenopausal state

Datatyp

boolean

Alias
UMLS CUI [1]
C0232970
≥ 12 months since the last menstrual period
Beskrivning

Elapsed Time Menstrual period Last

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2826303
UMLS CUI [1,2]
C0025329
UMLS CUI [1,3]
C1517741
prior bilateral oophorectomy
Beskrivning

Bilateral oophorectomy

Datatyp

boolean

Alias
UMLS CUI [1]
C0278321
previous hysterectomy with one or both ovaries left in place (or previous hysterectomy in which documentation of bilateral oophorectomy is unavailable) and follicle-stimulating hormone (fsh) values consistent with the institutional normal values for the postmenopausal state; fsh levels must be obtained within 28 days prior to registration
Beskrivning

Hysterectomy Previous | Removal of solitary ovary | Both ovaries Remaining | Bilateral oophorectomy Unavailable | Follicle stimulating hormone measurement Consistent with Postmenopausal state

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020699
UMLS CUI [1,2]
C0205156
UMLS CUI [2]
C0195497
UMLS CUI [3,1]
C0227898
UMLS CUI [3,2]
C1527428
UMLS CUI [4,1]
C0278321
UMLS CUI [4,2]
C0686905
UMLS CUI [5,1]
C0202022
UMLS CUI [5,2]
C0332290
UMLS CUI [5,3]
C0232970
patients must be willing to provide urine specimen to test for the presence of aromatase inhibitor within 28 days of randomization and at each 3-month clinic visit for 3 years
Beskrivning

Availability of Urine Specimen | Testing Aromatase Inhibitors

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C1610733
UMLS CUI [2,1]
C0039593
UMLS CUI [2,2]
C0593802
patients must have the ability to speak and read english
Beskrivning

Able to speak English Language | Able to read English Language

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0586740
UMLS CUI [2,2]
C0376245
patients must have a zubrod performance status of 0 - 2
Beskrivning

Zubrod Performance Status

Datatyp

boolean

Alias
UMLS CUI [1]
C3714786
no other prior malignancy (i.e., other than as noted on disease characteristics) is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for > 5 years
Beskrivning

Cancer Other Absent | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Disease Free Duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0012634
UMLS CUI [5,3]
C0332296
UMLS CUI [5,4]
C0449238
patients are allowed to participate in another clinical trial as long as it does not interfere with daily intake of aromatase-inhibitor therapy
Beskrivning

Study Subject Participation Status | Interference Absent Aromatase Inhibitors

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0521102
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0593802
prior concurrent therapy:
Beskrivning

Prior Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C1514463
patients must be post adjuvant chemotherapy (if to be utilized) and primary curative surgery and must have recovered from all side-effects of the surgery
Beskrivning

Status post Adjuvant Chemotherapy | Status post Curative Surgery | Side effects Due to Operative Surgical Procedures | Patient recovered

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0231290
UMLS CUI [1,2]
C0085533
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C1511562
UMLS CUI [3,1]
C0879626
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0543467
UMLS CUI [4]
C1115804
trastuzumab (herceptin) given alone after cytotoxic chemotherapy is considered adjuvant chemotherapy; patients would be eligible upon completion of herceptin as long as the other eligibility criteria are met
Beskrivning

Trastuzumab Adjuvant Chemotherapy | Herceptin Adjuvant Chemotherapy | Status post Cytotoxic Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0728747
UMLS CUI [1,2]
C0085533
UMLS CUI [2,1]
C0338204
UMLS CUI [2,2]
C0085533
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0677881
patients must be currently taking an aromatase inhibitor (ai), have completed at least one month of ai therapy, be within the first 5 years of planned ai therapy, and have at least 3 years remaining before completion of planned ai therapy
Beskrivning

Aromatase Inhibitors | Aromatase Inhibitors Treatment completed | Aromatase Inhibitors Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0593802
UMLS CUI [2,1]
C0593802
UMLS CUI [2,2]
C0580352
UMLS CUI [3,1]
C0593802
UMLS CUI [3,2]
C1301732
exclusion criteria: insufficient evidence of post-menopausal status; metastatic or recurrent disease; currently receiving chemotherapy.
Beskrivning

Exclusion Criteria | Evidence of Postmenopausal state Insufficient | Neoplasm Metastasis | Recurrent disease | Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0332120
UMLS CUI [2,2]
C0232970
UMLS CUI [2,3]
C0231180
UMLS CUI [3]
C0027627
UMLS CUI [4]
C0277556
UMLS CUI [5]
C0392920
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Similar models

Eligibility Breast Cancer NCT01515800

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Gender | Breast adenocarcinoma Invasive TNM Breast tumor staging | Breast adenocarcinoma Invasive Hormone-sensitive | Breast adenocarcinoma Invasive Estrogen receptor positive | Breast adenocarcinoma Invasive Progesterone receptor positive | Recurrent disease Absent | Neoplasm Metastasis Absent
Item
patients must be women with a diagnosis of histologically confirmed, primary invasive, hormone-sensitive (estrogen receptor-positive [er]/progesterone receptor [pr]-positive) adenocarcinoma of the breast (stage i, ii or iii) with no evidence of recurrent or metastatic disease (m0)
boolean
C0079399 (UMLS CUI [1])
C0858252 (UMLS CUI [2,1])
C0205281 (UMLS CUI [2,2])
C0474926 (UMLS CUI [2,3])
C0858252 (UMLS CUI [3,1])
C0205281 (UMLS CUI [3,2])
C1512498 (UMLS CUI [3,3])
C0858252 (UMLS CUI [4,1])
C0205281 (UMLS CUI [4,2])
C0279754 (UMLS CUI [4,3])
C0858252 (UMLS CUI [5,1])
C0205281 (UMLS CUI [5,2])
C0279759 (UMLS CUI [5,3])
C0277556 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0027627 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
Availability of Mobile Phone | Mobile Phone Receive Text Messages | Use of Text Messaging | Learning Text Messaging
Item
patients must have a mobile phone that can receive text messages and must currently use or be willing to learn to use text messaging
boolean
C0470187 (UMLS CUI [1,1])
C1136360 (UMLS CUI [1,2])
C1136360 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
C3178910 (UMLS CUI [2,3])
C1524063 (UMLS CUI [3,1])
C3178908 (UMLS CUI [3,2])
C0023185 (UMLS CUI [4,1])
C3178908 (UMLS CUI [4,2])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Postmenopausal state
Item
patients must be postmenopausal, as defined by at least one of the following:
boolean
C0232970 (UMLS CUI [1])
Elapsed Time Menstrual period Last
Item
≥ 12 months since the last menstrual period
boolean
C2826303 (UMLS CUI [1,1])
C0025329 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
Bilateral oophorectomy
Item
prior bilateral oophorectomy
boolean
C0278321 (UMLS CUI [1])
Hysterectomy Previous | Removal of solitary ovary | Both ovaries Remaining | Bilateral oophorectomy Unavailable | Follicle stimulating hormone measurement Consistent with Postmenopausal state
Item
previous hysterectomy with one or both ovaries left in place (or previous hysterectomy in which documentation of bilateral oophorectomy is unavailable) and follicle-stimulating hormone (fsh) values consistent with the institutional normal values for the postmenopausal state; fsh levels must be obtained within 28 days prior to registration
boolean
C0020699 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0195497 (UMLS CUI [2])
C0227898 (UMLS CUI [3,1])
C1527428 (UMLS CUI [3,2])
C0278321 (UMLS CUI [4,1])
C0686905 (UMLS CUI [4,2])
C0202022 (UMLS CUI [5,1])
C0332290 (UMLS CUI [5,2])
C0232970 (UMLS CUI [5,3])
Availability of Urine Specimen | Testing Aromatase Inhibitors
Item
patients must be willing to provide urine specimen to test for the presence of aromatase inhibitor within 28 days of randomization and at each 3-month clinic visit for 3 years
boolean
C0470187 (UMLS CUI [1,1])
C1610733 (UMLS CUI [1,2])
C0039593 (UMLS CUI [2,1])
C0593802 (UMLS CUI [2,2])
Able to speak English Language | Able to read English Language
Item
patients must have the ability to speak and read english
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0586740 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
Zubrod Performance Status
Item
patients must have a zubrod performance status of 0 - 2
boolean
C3714786 (UMLS CUI [1])
Cancer Other Absent | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Disease Free Duration
Item
no other prior malignancy (i.e., other than as noted on disease characteristics) is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for > 5 years
boolean
C1707251 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0332296 (UMLS CUI [5,3])
C0449238 (UMLS CUI [5,4])
Study Subject Participation Status | Interference Absent Aromatase Inhibitors
Item
patients are allowed to participate in another clinical trial as long as it does not interfere with daily intake of aromatase-inhibitor therapy
boolean
C2348568 (UMLS CUI [1])
C0521102 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0593802 (UMLS CUI [2,3])
Prior Therapy
Item
prior concurrent therapy:
boolean
C1514463 (UMLS CUI [1])
Status post Adjuvant Chemotherapy | Status post Curative Surgery | Side effects Due to Operative Surgical Procedures | Patient recovered
Item
patients must be post adjuvant chemotherapy (if to be utilized) and primary curative surgery and must have recovered from all side-effects of the surgery
boolean
C0231290 (UMLS CUI [1,1])
C0085533 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C1511562 (UMLS CUI [2,2])
C0879626 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0543467 (UMLS CUI [3,3])
C1115804 (UMLS CUI [4])
Trastuzumab Adjuvant Chemotherapy | Herceptin Adjuvant Chemotherapy | Status post Cytotoxic Chemotherapy
Item
trastuzumab (herceptin) given alone after cytotoxic chemotherapy is considered adjuvant chemotherapy; patients would be eligible upon completion of herceptin as long as the other eligibility criteria are met
boolean
C0728747 (UMLS CUI [1,1])
C0085533 (UMLS CUI [1,2])
C0338204 (UMLS CUI [2,1])
C0085533 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C0677881 (UMLS CUI [3,2])
Aromatase Inhibitors | Aromatase Inhibitors Treatment completed | Aromatase Inhibitors Planned
Item
patients must be currently taking an aromatase inhibitor (ai), have completed at least one month of ai therapy, be within the first 5 years of planned ai therapy, and have at least 3 years remaining before completion of planned ai therapy
boolean
C0593802 (UMLS CUI [1])
C0593802 (UMLS CUI [2,1])
C0580352 (UMLS CUI [2,2])
C0593802 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
Exclusion Criteria | Evidence of Postmenopausal state Insufficient | Neoplasm Metastasis | Recurrent disease | Chemotherapy
Item
exclusion criteria: insufficient evidence of post-menopausal status; metastatic or recurrent disease; currently receiving chemotherapy.
boolean
C0680251 (UMLS CUI [1])
C0332120 (UMLS CUI [2,1])
C0232970 (UMLS CUI [2,2])
C0231180 (UMLS CUI [2,3])
C0027627 (UMLS CUI [3])
C0277556 (UMLS CUI [4])
C0392920 (UMLS CUI [5])
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