ID

27045

Description

Yoga or Educational Wellness Class for Women With Stage I, Stage II, or Stage III Breast Cancer Undergoing Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT00994279

Link

https://clinicaltrials.gov/show/NCT00994279

Keywords

Versions (1)
  1. 10/30/17 10/30/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 30, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00994279

English

Eligibility Breast Cancer NCT00994279

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women will be eligible if they are:
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
scheduled to begin chemotherapy treatment within 3 weeks of study registration, or able to start yoga/wellness sessions prior to second chemotherapy treatment.
Description

Chemotherapy Scheduled | Yoga activity Before Chemotherapy second | Wellness Program Before Chemotherapy second

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0205539
UMLS CUI [2,1]
C2979879
UMLS CUI [2,2]
C0332152
UMLS CUI [2,3]
C0392920
UMLS CUI [2,4]
C0205436
UMLS CUI [3,1]
C0043113
UMLS CUI [3,2]
C0332152
UMLS CUI [3,3]
C0392920
UMLS CUI [3,4]
C0205436
≥18 years of age.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
physically able to attend yoga classes (simply meaning that they can physically make it to the intervention session and are able to sit on a chair or lie on the floor) (ecog performance status rating 0-2; zubrod et al., 1960).
Description

Ability Participation Yoga activity | Able to sit down on a chair | Able to lie down | ECOG performance status | Zubrod Performance Status

Data type

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C0679823
UMLS CUI [1,3]
C2979879
UMLS CUI [2]
C0578338
UMLS CUI [3]
C0560841
UMLS CUI [4]
C1520224
UMLS CUI [5]
C3714786
diagnosed with breast cancer stages i-iii.
Description

Breast Carcinoma TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0474926
chemotherapy is anticipated to continue during the 10 weeks of the study intervention.
Description

Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
2-8 weeks post-completion of breast surgery (unless receiving neoadjuvant chemotherapy).
Description

Operation on breast Completed | Exception Chemotherapy Neoadjuvant

Data type

boolean

Alias
UMLS CUI [1,1]
C3714726
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0392920
UMLS CUI [2,3]
C0600558
ability to understand and the willingness to sign a written informed consent document.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
have practiced yoga on a regular basis (at least once a week) within the past 4 weeks to recruit women who are not already regularly practicing yoga. given that the benefits of yoga are likely more immediate than long-term, however, we will enroll women who have previously had a yoga practice.
Description

Yoga activity Regular Frequency

Data type

boolean

Alias
UMLS CUI [1,1]
C2979879
UMLS CUI [1,2]
C0205272
UMLS CUI [1,3]
C0439603
are being treated with surgery and/or radiation therapy and/or hormonal treatment only and/or herceptin therapy only (no chemotherapy).
Description

Operative Surgical Procedures | Therapeutic radiology procedure | Hormone Therapy | Herceptin | Chemotherapy Absent

Data type

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0279025
UMLS CUI [4]
C0338204
UMLS CUI [5,1]
C0392920
UMLS CUI [5,2]
C0332197
anticipate undergoing surgery related to their breast cancer or receipt of radiation therapy during the study period.
Description

Operative Surgical Procedures Anticipated Breast Carcinoma | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C3840775
UMLS CUI [1,3]
C0678222
UMLS CUI [2]
C1522449
have regularly engaged in moderate (activity that makes you breathe somewhat harder than normal; may include carrying light loads, bicycling at a regular pace, fast walking, tennis, easy swimming, or popular or folk dancing) or vigorous (activity that causes heavy breathing, sweating, rapid fatigue; it can only be sustained for very short periods of time, like running or swimming strongly) physical activity at least 3-5 days per week (on average) within the past 4 weeks.
Description

Physical activity Moderate Frequency | Bicycling | Walking fast | Tennis | Swimming Easy | Dancing | Vigorous physical activity Frequency | Running | Swimming Strong

Data type

boolean

Alias
UMLS CUI [1,1]
C0026606
UMLS CUI [1,2]
C0205081
UMLS CUI [1,3]
C0439603
UMLS CUI [2]
C0005377
UMLS CUI [3,1]
C0080331
UMLS CUI [3,2]
C0456962
UMLS CUI [4]
C0039515
UMLS CUI [5,1]
C0039003
UMLS CUI [5,2]
C0332219
UMLS CUI [6]
C0010963
UMLS CUI [7,1]
C4267713
UMLS CUI [7,2]
C0439603
UMLS CUI [8]
C0035953
UMLS CUI [9,1]
C0039003
UMLS CUI [9,2]
C0442821
pregnant women will not be excluded from this study because the study intervention(s) pose no risk of potential for teratogenic or abortifacient effects. in fact, gentle yoga practice is quite safe for pregnant women and poses can be slightly modified, if needed. the anticipated number of pregnant women eligible to enroll is minimal.
Description

Pregnancy Yoga activity Recommended

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C2979879
UMLS CUI [1,3]
C0034866
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Similar models

Eligibility Breast Cancer NCT00994279

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
women will be eligible if they are:
boolean
C0079399 (UMLS CUI [1])
Chemotherapy Scheduled | Yoga activity Before Chemotherapy second | Wellness Program Before Chemotherapy second
Item
scheduled to begin chemotherapy treatment within 3 weeks of study registration, or able to start yoga/wellness sessions prior to second chemotherapy treatment.
boolean
C0392920 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C2979879 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0392920 (UMLS CUI [2,3])
C0205436 (UMLS CUI [2,4])
C0043113 (UMLS CUI [3,1])
C0332152 (UMLS CUI [3,2])
C0392920 (UMLS CUI [3,3])
C0205436 (UMLS CUI [3,4])
Age
Item
≥18 years of age.
boolean
C0001779 (UMLS CUI [1])
Ability Participation Yoga activity | Able to sit down on a chair | Able to lie down | ECOG performance status | Zubrod Performance Status
Item
physically able to attend yoga classes (simply meaning that they can physically make it to the intervention session and are able to sit on a chair or lie on the floor) (ecog performance status rating 0-2; zubrod et al., 1960).
boolean
C0085732 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C2979879 (UMLS CUI [1,3])
C0578338 (UMLS CUI [2])
C0560841 (UMLS CUI [3])
C1520224 (UMLS CUI [4])
C3714786 (UMLS CUI [5])
Breast Carcinoma TNM Breast tumor staging
Item
diagnosed with breast cancer stages i-iii.
boolean
C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Chemotherapy
Item
chemotherapy is anticipated to continue during the 10 weeks of the study intervention.
boolean
C0392920 (UMLS CUI [1])
Operation on breast Completed | Exception Chemotherapy Neoadjuvant
Item
2-8 weeks post-completion of breast surgery (unless receiving neoadjuvant chemotherapy).
boolean
C3714726 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C0600558 (UMLS CUI [2,3])
Informed Consent
Item
ability to understand and the willingness to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Yoga activity Regular Frequency
Item
have practiced yoga on a regular basis (at least once a week) within the past 4 weeks to recruit women who are not already regularly practicing yoga. given that the benefits of yoga are likely more immediate than long-term, however, we will enroll women who have previously had a yoga practice.
boolean
C2979879 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
Operative Surgical Procedures | Therapeutic radiology procedure | Hormone Therapy | Herceptin | Chemotherapy Absent
Item
are being treated with surgery and/or radiation therapy and/or hormonal treatment only and/or herceptin therapy only (no chemotherapy).
boolean
C0543467 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0279025 (UMLS CUI [3])
C0338204 (UMLS CUI [4])
C0392920 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Operative Surgical Procedures Anticipated Breast Carcinoma | Therapeutic radiology procedure
Item
anticipate undergoing surgery related to their breast cancer or receipt of radiation therapy during the study period.
boolean
C0543467 (UMLS CUI [1,1])
C3840775 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2])
Physical activity Moderate Frequency | Bicycling | Walking fast | Tennis | Swimming Easy | Dancing | Vigorous physical activity Frequency | Running | Swimming Strong
Item
have regularly engaged in moderate (activity that makes you breathe somewhat harder than normal; may include carrying light loads, bicycling at a regular pace, fast walking, tennis, easy swimming, or popular or folk dancing) or vigorous (activity that causes heavy breathing, sweating, rapid fatigue; it can only be sustained for very short periods of time, like running or swimming strongly) physical activity at least 3-5 days per week (on average) within the past 4 weeks.
boolean
C0026606 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
C0005377 (UMLS CUI [2])
C0080331 (UMLS CUI [3,1])
C0456962 (UMLS CUI [3,2])
C0039515 (UMLS CUI [4])
C0039003 (UMLS CUI [5,1])
C0332219 (UMLS CUI [5,2])
C0010963 (UMLS CUI [6])
C4267713 (UMLS CUI [7,1])
C0439603 (UMLS CUI [7,2])
C0035953 (UMLS CUI [8])
C0039003 (UMLS CUI [9,1])
C0442821 (UMLS CUI [9,2])
Pregnancy Yoga activity Recommended
Item
pregnant women will not be excluded from this study because the study intervention(s) pose no risk of potential for teratogenic or abortifacient effects. in fact, gentle yoga practice is quite safe for pregnant women and poses can be slightly modified, if needed. the anticipated number of pregnant women eligible to enroll is minimal.
boolean
C0032961 (UMLS CUI [1,1])
C2979879 (UMLS CUI [1,2])
C0034866 (UMLS CUI [1,3])
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