ID

27045

Beschreibung

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

Stichworte

Versionen (1)
  1. 30.10.17 30.10.17 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

30. Oktober 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00994279

Englisch

Eligibility Breast Cancer NCT00994279

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Gender

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Age

Datentyp

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).
Beschreibung

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

Datentyp

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.
Beschreibung

Breast Carcinoma TNM Breast tumor staging

Datentyp

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.
Beschreibung

Chemotherapy

Datentyp

boolean

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

Operation on breast Completed | Exception Chemotherapy Neoadjuvant

Datentyp

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.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

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.
Beschreibung

Yoga activity Regular Frequency

Datentyp

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).
Beschreibung

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

Datentyp

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.
Beschreibung

Operative Surgical Procedures Anticipated Breast Carcinoma | Therapeutic radiology procedure

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Pregnancy Yoga activity Recommended

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C2979879
UMLS CUI [1,3]
C0034866
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Ähnliche Modelle

Eligibility Breast Cancer NCT00994279

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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