ID

37765

Description

Guided Relaxation Training for the Reduction of Self-Reported Stress in Individuals With Newly Diagnosed Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00945607

Link

https://clinicaltrials.gov/show/NCT00945607

Keywords

Versions (1)
  1. 8/22/19 8/22/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 22, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00945607

English

Eligibility Breast Cancer NCT00945607

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
able to speak and understand english
Description

Able to speak English Language | Comprehension English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0233733
UMLS CUI [2,2]
C0376245
at or between the ages of 18 and 75
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
newly diagnosed with breast cancer (within 12 weeks of study entry)
Description

Breast Carcinoma Newly Diagnosed

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C1518321
expected to receive chemotherapy and/or radiation
Description

Chemotherapy Expected | Therapeutic radiology procedure Expected

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1517001
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C1517001
willingness to complete cses, pss-14 and facit-f scales
Description

Self-Evaluation Scale Completion | PSS-14 Questionnaire Completion | FACIT Fatigue Scale Completion

Data type

boolean

Alias
UMLS CUI [1,1]
C2936633
UMLS CUI [1,2]
C0349674
UMLS CUI [1,3]
C0205197
UMLS CUI [2,1]
C4288413
UMLS CUI [2,2]
C0205197
UMLS CUI [3,1]
C3272505
UMLS CUI [3,2]
C0205197
minimum score of 4 on the 0-10 visual analog scale for stress
Description

Visual Analog Scale Stress

Data type

boolean

Alias
UMLS CUI [1,1]
C3536884
UMLS CUI [1,2]
C0038435
willingness to participate for the 18 week duration of study and follow-up
Description

Study Subject Participation Status Willing | Follow-up Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0600109
UMLS CUI [2,1]
C3274571
UMLS CUI [2,2]
C0600109
ability to travel to cancer center weekly specifically for on-site guided relaxation training sessions
Description

Participation Relaxation Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0282333
access to a cd player
Description

Access Compact discs | Other Coding

Data type

boolean

Alias
UMLS CUI [1,1]
C0444454
UMLS CUI [1,2]
C0079141
UMLS CUI [2]
C3846158
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
cognitive or mental status affecting ability to follow directions
Description

Cognitive status Affecting Ability Follow directions | Mental state Affecting Ability Follow directions

Data type

boolean

Alias
UMLS CUI [1,1]
C0945985
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0085732
UMLS CUI [1,4]
C1720622
UMLS CUI [2,1]
C0278060
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0085732
UMLS CUI [2,4]
C1720622
previous or current use of complementary therapies for their cancer diagnosis, except herbal supplements
Description

Complementary therapy Malignant Neoplasms | Exception Herbal Supplements

Data type

boolean

Alias
UMLS CUI [1,1]
C0936077
UMLS CUI [1,2]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1504473
brain metastasis
Description

Metastatic malignant neoplasm to brain

Data type

boolean

Alias
UMLS CUI [1]
C0220650
treatment for any other diagnosis of cancer within the previous 5 years
Description

Treatment Cancer Other

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1707251
any condition that, in the opinion of the investigator might interfere with the subject's participation in the study, pose an added risk for the subject or confound the assessment of the subject
Description

Condition Interferes with Study Subject Participation Status | Condition At risk Study Subject | Condition Interferes with Assessment Study Subject

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C0681850
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C1516048
UMLS CUI [3,4]
C0681850
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Similar models

Eligibility Breast Cancer NCT00945607

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Able to speak English Language | Comprehension English Language
Item
able to speak and understand english
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0233733 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
Age
Item
at or between the ages of 18 and 75
boolean
C0001779 (UMLS CUI [1])
Breast Carcinoma Newly Diagnosed
Item
newly diagnosed with breast cancer (within 12 weeks of study entry)
boolean
C0678222 (UMLS CUI [1,1])
C1518321 (UMLS CUI [1,2])
Chemotherapy Expected | Therapeutic radiology procedure Expected
Item
expected to receive chemotherapy and/or radiation
boolean
C0392920 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C1517001 (UMLS CUI [2,2])
Self-Evaluation Scale Completion | PSS-14 Questionnaire Completion | FACIT Fatigue Scale Completion
Item
willingness to complete cses, pss-14 and facit-f scales
boolean
C2936633 (UMLS CUI [1,1])
C0349674 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C4288413 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C3272505 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
Visual Analog Scale Stress
Item
minimum score of 4 on the 0-10 visual analog scale for stress
boolean
C3536884 (UMLS CUI [1,1])
C0038435 (UMLS CUI [1,2])
Study Subject Participation Status Willing | Follow-up Willing
Item
willingness to participate for the 18 week duration of study and follow-up
boolean
C2348568 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C3274571 (UMLS CUI [2,1])
C0600109 (UMLS CUI [2,2])
Participation Relaxation Therapy
Item
ability to travel to cancer center weekly specifically for on-site guided relaxation training sessions
boolean
C0679823 (UMLS CUI [1,1])
C0282333 (UMLS CUI [1,2])
Access Compact discs | Other Coding
Item
access to a cd player
boolean
C0444454 (UMLS CUI [1,1])
C0079141 (UMLS CUI [1,2])
C3846158 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Cognitive status Affecting Ability Follow directions | Mental state Affecting Ability Follow directions
Item
cognitive or mental status affecting ability to follow directions
boolean
C0945985 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C1720622 (UMLS CUI [1,4])
C0278060 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0085732 (UMLS CUI [2,3])
C1720622 (UMLS CUI [2,4])
Complementary therapy Malignant Neoplasms | Exception Herbal Supplements
Item
previous or current use of complementary therapies for their cancer diagnosis, except herbal supplements
boolean
C0936077 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1504473 (UMLS CUI [2,2])
Metastatic malignant neoplasm to brain
Item
brain metastasis
boolean
C0220650 (UMLS CUI [1])
Treatment Cancer Other
Item
treatment for any other diagnosis of cancer within the previous 5 years
boolean
C0087111 (UMLS CUI [1,1])
C1707251 (UMLS CUI [1,2])
Condition Interferes with Study Subject Participation Status | Condition At risk Study Subject | Condition Interferes with Assessment Study Subject
Item
any condition that, in the opinion of the investigator might interfere with the subject's participation in the study, pose an added risk for the subject or confound the assessment of the subject
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0681850 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C1516048 (UMLS CUI [3,3])
C0681850 (UMLS CUI [3,4])
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