ID

39251

Description

POWER-remote Weight Loss Program in Early Stage Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01871116

Link

https://clinicaltrials.gov/show/NCT01871116

Keywords

Versions (1)
  1. 12/12/19 12/12/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 12, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0
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Eligibility Early Stage Breast Cancer NCT01871116

English

Eligibility Early Stage Breast Cancer NCT01871116

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
18 years or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
ductal carcinoma in situ (dcis) or stage i-iii invasive breast cancer
Description

DCIS | Invasive carcinoma of breast TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1]
C0007124
UMLS CUI [2,1]
C0853879
UMLS CUI [2,2]
C0474926
eastern cooperative oncology group (ecog) performance status 0-2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
current bmi ≥ 25 kg/m2 and weight ≤ 400 lbs, and willing to lose >5% of their body weight. note: participants may not have documented weight loss greater than 5% of body weight from time of diagnosis. exceptions that are felt to be due to surgical or other procedures (e.g., mastectomies or reconstruction) may be allowed with prior approval of the protocol chair/designee.
Description

Body mass index | Body Weight | Lose weight Percentage Willing

Data type

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0005910
UMLS CUI [3,1]
C1262477
UMLS CUI [3,2]
C0439165
UMLS CUI [3,3]
C0600109
patients must have completed local therapy (i.e. surgery and radiation therapy), and any preoperative or adjuvant chemotherapy within >3 and <60 months of registration. note: concurrent anti-her2 therapy is permitted. concurrent endocrine breast cancer therapy is permitted; patients may enroll >3 months after initiation of hormone therapy if expected to continue the same hormone agent for at least the first 6 months of the study. concurrent enrollment in other interventional or drug clinical trials is at the discretion of the protocol chair.
Description

Local Therapy Completed | Operative Surgical Procedures Completed | Therapeutic radiology procedure Completed | Preoperative Chemotherapy Completed | Adjuvant Chemotherapy Completed | Targeted Therapy HER2 | Hormone Therapy Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1517925
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0205197
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0205197
UMLS CUI [4,1]
C2347669
UMLS CUI [4,2]
C0205197
UMLS CUI [5,1]
C0085533
UMLS CUI [5,2]
C0205197
UMLS CUI [6,1]
C2985566
UMLS CUI [6,2]
C0069515
UMLS CUI [7,1]
C0279025
UMLS CUI [7,2]
C0678222
willingness to change diet, physical activity and weight.
Description

Change in diet Willing | Change Physical activity Willing | Body Weight Change Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C3671772
UMLS CUI [1,2]
C0600109
UMLS CUI [2,1]
C0392747
UMLS CUI [2,2]
C0026606
UMLS CUI [2,3]
C0600109
UMLS CUI [3,1]
C0005911
UMLS CUI [3,2]
C0600109
to ensure compliance with the power-remote and patientviewpoint programs, patients must meet the following: prior experience with web forms and feels able to use the power-remote web program and patientviewpoint; has or is able to download internet explorer 8+, firefox 3.0+, safari 4.0+, chrome 4.0+, and adobe flash player 10; familiarity with and access to internet at least 4 days per week; use of an email program or willing and able to establish one for this study; and, able to read and write the english language without assistance.
Description

Compliance Computer software | Compliance Computer Application | Compliance Web Browser | Compliance Internet | Use of Email | Able to read English Language | Able to write English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0037585
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0870325
UMLS CUI [3,1]
C1321605
UMLS CUI [3,2]
C3658317
UMLS CUI [4,1]
C1321605
UMLS CUI [4,2]
C0282111
UMLS CUI [5,1]
C1524063
UMLS CUI [5,2]
C0013849
UMLS CUI [6,1]
C0586740
UMLS CUI [6,2]
C0376245
UMLS CUI [7,1]
C0584993
UMLS CUI [7,2]
C0376245
patient is aware of her diagnosis, understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form.
Description

Comprehension Study Protocol | Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of another prior cancer within the last 5 years, with the exception of another breast cancer, adequately treated cone-biopsied in situ carcinoma of the cervix uteri, and basal or squamous cell carcinoma of the skin
Description

Cancer Other | Exception Breast Carcinoma | Exception Cone biopsy Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0678222
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0195324
UMLS CUI [3,3]
C0851140
UMLS CUI [3,4]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007117
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0553723
UMLS CUI [5,3]
C1522326
medical condition likely to hinder accurate measurement of weight, including any condition: for which weight loss is contraindicated, which would likely cause weight loss, or which would affect adipokine and inflammatory markers (e.g., end stage renal disease (esrd) on dialysis, cirrhosis, autoimmune disease, adrenal disease, and history of bariatric surgery).
Description

Medical condition Interferes with Body Weight Measurement | Condition Weight loss Contraindicated | Condition Causing Weight loss | Condition Affecting Adipokine | Condition Affecting Inflammatory marker | Chronic Kidney Failure Dialysis | Liver Cirrhosis | Autoimmune Disease | Adrenal Gland Diseases | Bariatric Surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2985231
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C1262477
UMLS CUI [2,3]
C1444657
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0678227
UMLS CUI [3,3]
C1262477
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C1955907
UMLS CUI [5,1]
C0348080
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C3805088
UMLS CUI [6,1]
C0022661
UMLS CUI [6,2]
C0011946
UMLS CUI [7]
C0023890
UMLS CUI [8]
C0004364
UMLS CUI [9]
C0001621
UMLS CUI [10]
C1456587
the use of the following medications are excluded: insulin or sulfonlyureas; patients with thyroid disease who are not on stable doses of thyroid medication for at least the past 6 months; medications that cause weight loss (e.g., topiramate, bupropion, exenatide, lorcaserin, phentermine or orlistat) within the past 3 months; medications that are likely to cause weight gain or prevent weight loss (e.g., corticosteroids, lithium, olanzapine, risperidone, clozapine, oral contraceptive pills, hormone replacement therapy) within the past 3 months; medications that may affect adipokine or inflammatory markers (e.g., sulfonylureas, glitazones, insulin, steroids, ace inhibitors, beta blockers and statins) unless started ≥3 months prior to enrollment, or chronic nsaids (defined as use of ≥3 times a week) for ≥1 month.
Description

Insulin | Sulfonylurea | Thyroid Disease | Absence Thyroid preparations Dose Stable | Weight-Loss Agents | topiramate | Bupropion | exenatide | lorcaserin | Phentermine | orlistat | Pharmaceutical Preparations Causing Weight Gain | Pharmaceutical Preparations Preventing Weight loss | Adrenal Cortex Hormones | Lithium | olanzapine | Risperidone | Clozapine | Contraceptives, Oral | Hormone replacement therapy | Pharmaceutical Preparations Affecting Adipokines | Pharmaceutical Preparations Affecting Inflammatory marker | Sulfonylurea | Thiazolidinediones | Insulin | Steroids | Angiotensin-Converting Enzyme Inhibitors | Adrenergic beta-1 Receptor Antagonists | Statins | NSAIDs chronic

Data type

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2]
C0038766
UMLS CUI [3]
C0040128
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C0279175
UMLS CUI [4,3]
C0178602
UMLS CUI [4,4]
C0205360
UMLS CUI [5]
C0376606
UMLS CUI [6]
C0076829
UMLS CUI [7]
C0085208
UMLS CUI [8]
C0167117
UMLS CUI [9]
C2350948
UMLS CUI [10]
C0031447
UMLS CUI [11]
C0076275
UMLS CUI [12,1]
C0013227
UMLS CUI [12,2]
C0678227
UMLS CUI [12,3]
C0043094
UMLS CUI [13,1]
C0013227
UMLS CUI [13,2]
C1292733
UMLS CUI [13,3]
C1262477
UMLS CUI [14]
C0001617
UMLS CUI [15]
C0023870
UMLS CUI [16]
C0171023
UMLS CUI [17]
C0073393
UMLS CUI [18]
C0009079
UMLS CUI [19]
C0009905
UMLS CUI [20]
C0282402
UMLS CUI [21,1]
C0013227
UMLS CUI [21,2]
C0392760
UMLS CUI [21,3]
C1955907
UMLS CUI [22,1]
C0013227
UMLS CUI [22,2]
C0392760
UMLS CUI [22,3]
C3805088
UMLS CUI [23]
C0038766
UMLS CUI [24]
C1257987
UMLS CUI [25]
C0021641
UMLS CUI [26]
C0038317
UMLS CUI [27]
C0003015
UMLS CUI [28]
C0304516
UMLS CUI [29]
C0360714
UMLS CUI [30,1]
C0003211
UMLS CUI [30,2]
C0205191
pregnant or nursing within past 6 months, or plans to become pregnant in the next year
Description

Pregnancy | Breast Feeding | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
currently enrolled or planning to enroll in a weight loss program (e.g., innergy, weight watchers, jenny craig, nutrisystem, and medifast).
Description

Enrollment Weight Reduction Program | Enrollment Planned Weight Reduction Program | Other Coding

Data type

boolean

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C3179079
UMLS CUI [2,1]
C1516879
UMLS CUI [2,2]
C1301732
UMLS CUI [2,3]
C3179079
UMLS CUI [3]
C3846158
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Similar models

Eligibility Early Stage Breast Cancer NCT01871116

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
women
boolean
C0079399 (UMLS CUI [1])
Age
Item
18 years or older
boolean
C0001779 (UMLS CUI [1])
DCIS | Invasive carcinoma of breast TNM Breast tumor staging
Item
ductal carcinoma in situ (dcis) or stage i-iii invasive breast cancer
boolean
C0007124 (UMLS CUI [1])
C0853879 (UMLS CUI [2,1])
C0474926 (UMLS CUI [2,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Body mass index | Body Weight | Lose weight Percentage Willing
Item
current bmi ≥ 25 kg/m2 and weight ≤ 400 lbs, and willing to lose >5% of their body weight. note: participants may not have documented weight loss greater than 5% of body weight from time of diagnosis. exceptions that are felt to be due to surgical or other procedures (e.g., mastectomies or reconstruction) may be allowed with prior approval of the protocol chair/designee.
boolean
C1305855 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
C1262477 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
C0600109 (UMLS CUI [3,3])
Local Therapy Completed | Operative Surgical Procedures Completed | Therapeutic radiology procedure Completed | Preoperative Chemotherapy Completed | Adjuvant Chemotherapy Completed | Targeted Therapy HER2 | Hormone Therapy Breast Carcinoma
Item
patients must have completed local therapy (i.e. surgery and radiation therapy), and any preoperative or adjuvant chemotherapy within >3 and <60 months of registration. note: concurrent anti-her2 therapy is permitted. concurrent endocrine breast cancer therapy is permitted; patients may enroll >3 months after initiation of hormone therapy if expected to continue the same hormone agent for at least the first 6 months of the study. concurrent enrollment in other interventional or drug clinical trials is at the discretion of the protocol chair.
boolean
C1517925 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
C2347669 (UMLS CUI [4,1])
C0205197 (UMLS CUI [4,2])
C0085533 (UMLS CUI [5,1])
C0205197 (UMLS CUI [5,2])
C2985566 (UMLS CUI [6,1])
C0069515 (UMLS CUI [6,2])
C0279025 (UMLS CUI [7,1])
C0678222 (UMLS CUI [7,2])
Change in diet Willing | Change Physical activity Willing | Body Weight Change Willing
Item
willingness to change diet, physical activity and weight.
boolean
C3671772 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0392747 (UMLS CUI [2,1])
C0026606 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
C0005911 (UMLS CUI [3,1])
C0600109 (UMLS CUI [3,2])
Compliance Computer software | Compliance Computer Application | Compliance Web Browser | Compliance Internet | Use of Email | Able to read English Language | Able to write English Language
Item
to ensure compliance with the power-remote and patientviewpoint programs, patients must meet the following: prior experience with web forms and feels able to use the power-remote web program and patientviewpoint; has or is able to download internet explorer 8+, firefox 3.0+, safari 4.0+, chrome 4.0+, and adobe flash player 10; familiarity with and access to internet at least 4 days per week; use of an email program or willing and able to establish one for this study; and, able to read and write the english language without assistance.
boolean
C1321605 (UMLS CUI [1,1])
C0037585 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2,1])
C0870325 (UMLS CUI [2,2])
C1321605 (UMLS CUI [3,1])
C3658317 (UMLS CUI [3,2])
C1321605 (UMLS CUI [4,1])
C0282111 (UMLS CUI [4,2])
C1524063 (UMLS CUI [5,1])
C0013849 (UMLS CUI [5,2])
C0586740 (UMLS CUI [6,1])
C0376245 (UMLS CUI [6,2])
C0584993 (UMLS CUI [7,1])
C0376245 (UMLS CUI [7,2])
Comprehension Study Protocol | Informed Consent
Item
patient is aware of her diagnosis, understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Cancer Other | Exception Breast Carcinoma | Exception Cone biopsy Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
history of another prior cancer within the last 5 years, with the exception of another breast cancer, adequately treated cone-biopsied in situ carcinoma of the cervix uteri, and basal or squamous cell carcinoma of the skin
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0195324 (UMLS CUI [3,2])
C0851140 (UMLS CUI [3,3])
C1522326 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0553723 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
Medical condition Interferes with Body Weight Measurement | Condition Weight loss Contraindicated | Condition Causing Weight loss | Condition Affecting Adipokine | Condition Affecting Inflammatory marker | Chronic Kidney Failure Dialysis | Liver Cirrhosis | Autoimmune Disease | Adrenal Gland Diseases | Bariatric Surgery
Item
medical condition likely to hinder accurate measurement of weight, including any condition: for which weight loss is contraindicated, which would likely cause weight loss, or which would affect adipokine and inflammatory markers (e.g., end stage renal disease (esrd) on dialysis, cirrhosis, autoimmune disease, adrenal disease, and history of bariatric surgery).
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2985231 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C1262477 (UMLS CUI [2,2])
C1444657 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C0678227 (UMLS CUI [3,2])
C1262477 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C1955907 (UMLS CUI [4,3])
C0348080 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C3805088 (UMLS CUI [5,3])
C0022661 (UMLS CUI [6,1])
C0011946 (UMLS CUI [6,2])
C0023890 (UMLS CUI [7])
C0004364 (UMLS CUI [8])
C0001621 (UMLS CUI [9])
C1456587 (UMLS CUI [10])
Insulin | Sulfonylurea | Thyroid Disease | Absence Thyroid preparations Dose Stable | Weight-Loss Agents | topiramate | Bupropion | exenatide | lorcaserin | Phentermine | orlistat | Pharmaceutical Preparations Causing Weight Gain | Pharmaceutical Preparations Preventing Weight loss | Adrenal Cortex Hormones | Lithium | olanzapine | Risperidone | Clozapine | Contraceptives, Oral | Hormone replacement therapy | Pharmaceutical Preparations Affecting Adipokines | Pharmaceutical Preparations Affecting Inflammatory marker | Sulfonylurea | Thiazolidinediones | Insulin | Steroids | Angiotensin-Converting Enzyme Inhibitors | Adrenergic beta-1 Receptor Antagonists | Statins | NSAIDs chronic
Item
the use of the following medications are excluded: insulin or sulfonlyureas; patients with thyroid disease who are not on stable doses of thyroid medication for at least the past 6 months; medications that cause weight loss (e.g., topiramate, bupropion, exenatide, lorcaserin, phentermine or orlistat) within the past 3 months; medications that are likely to cause weight gain or prevent weight loss (e.g., corticosteroids, lithium, olanzapine, risperidone, clozapine, oral contraceptive pills, hormone replacement therapy) within the past 3 months; medications that may affect adipokine or inflammatory markers (e.g., sulfonylureas, glitazones, insulin, steroids, ace inhibitors, beta blockers and statins) unless started ≥3 months prior to enrollment, or chronic nsaids (defined as use of ≥3 times a week) for ≥1 month.
boolean
C0021641 (UMLS CUI [1])
C0038766 (UMLS CUI [2])
C0040128 (UMLS CUI [3])
C0332197 (UMLS CUI [4,1])
C0279175 (UMLS CUI [4,2])
C0178602 (UMLS CUI [4,3])
C0205360 (UMLS CUI [4,4])
C0376606 (UMLS CUI [5])
C0076829 (UMLS CUI [6])
C0085208 (UMLS CUI [7])
C0167117 (UMLS CUI [8])
C2350948 (UMLS CUI [9])
C0031447 (UMLS CUI [10])
C0076275 (UMLS CUI [11])
C0013227 (UMLS CUI [12,1])
C0678227 (UMLS CUI [12,2])
C0043094 (UMLS CUI [12,3])
C0013227 (UMLS CUI [13,1])
C1292733 (UMLS CUI [13,2])
C1262477 (UMLS CUI [13,3])
C0001617 (UMLS CUI [14])
C0023870 (UMLS CUI [15])
C0171023 (UMLS CUI [16])
C0073393 (UMLS CUI [17])
C0009079 (UMLS CUI [18])
C0009905 (UMLS CUI [19])
C0282402 (UMLS CUI [20])
C0013227 (UMLS CUI [21,1])
C0392760 (UMLS CUI [21,2])
C1955907 (UMLS CUI [21,3])
C0013227 (UMLS CUI [22,1])
C0392760 (UMLS CUI [22,2])
C3805088 (UMLS CUI [22,3])
C0038766 (UMLS CUI [23])
C1257987 (UMLS CUI [24])
C0021641 (UMLS CUI [25])
C0038317 (UMLS CUI [26])
C0003015 (UMLS CUI [27])
C0304516 (UMLS CUI [28])
C0360714 (UMLS CUI [29])
C0003211 (UMLS CUI [30,1])
C0205191 (UMLS CUI [30,2])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
pregnant or nursing within past 6 months, or plans to become pregnant in the next year
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Enrollment Weight Reduction Program | Enrollment Planned Weight Reduction Program | Other Coding
Item
currently enrolled or planning to enroll in a weight loss program (e.g., innergy, weight watchers, jenny craig, nutrisystem, and medifast).
boolean
C1516879 (UMLS CUI [1,1])
C3179079 (UMLS CUI [1,2])
C1516879 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C3179079 (UMLS CUI [2,3])
C3846158 (UMLS CUI [3])
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