ID

19613

Description

Effects of Hands-on-Healing vs. Touch for Fatigued Breast Cancer Survivors; ODM derived from: https://clinicaltrials.gov/show/NCT00440089

Link

https://clinicaltrials.gov/show/NCT00440089

Keywords

Versions (1)
  1. 1/16/17 1/16/17 -
Uploaded on

January 16, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00440089

English

Eligibility Breast Cancer NCT00440089

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
premenopausal and postmenopausal women between the ages of 18 to 70 years.
Description

Gender | Age | Premenopausal state | Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0232969
UMLS CUI [4]
C0232970
ability to give informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
breast cancer survivors who have undergone surgery, including lumpectomy and simple or total mastectomy, followed by chemotherapy or a combination of chemo- and radio-therapy. we have elected to study survivors instead of patients actively undergoing treatment to alleviate subject burden and risk during this protocol.
Description

Breast Carcinoma Survivors | Operative Surgical Procedures | Segmental Mastectomy | Simple mastectomy | Chemotherapy | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0206194
UMLS CUI [2]
C0543467
UMLS CUI [3]
C0024885
UMLS CUI [4]
C0024886
UMLS CUI [5]
C0392920
UMLS CUI [6]
C1522449
stage i to iii breast cancer survivors.
Description

Breast Carcinoma TNM clinical staging Survivors

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C3258246
UMLS CUI [1,3]
C0206194
breast cancer survivors who have finished their chemotherapy and/or radiotherapy at least one month prior to 60 months prior.
Description

Breast Carcinoma Survivors | Chemotherapy Completed | Therapeutic radiology procedure Completed

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0206194
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0205197
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0205197
breast cancer survivors with above-normative levels of fatigue.
Description

Breast Carcinoma Survivors | Fatigue Level Increased

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0206194
UMLS CUI [2,1]
C0015672
UMLS CUI [2,2]
C0441889
UMLS CUI [2,3]
C0205217
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
breast cancer patients who are currently receiving or who are scheduled to receive radiation or chemotherapy during the course of this intervention study.
Description

Therapeutic radiology procedure Breast Carcinoma | Chemotherapy Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0678222
patients with current major depression, current or history of prior bipolar illness, currently on psychotropic medications.
Description

Major Depressive Disorder | Bipolar Disorder | Psychotropic Drugs

Data type

boolean

Alias
UMLS CUI [1]
C1269683
UMLS CUI [2]
C0005586
UMLS CUI [3]
C0033978
patients with other diseases that are known to induce fatigue (e.g., thyroid disorder; sleep disorders).
Description

Disease Inducing Fatigue | Thyroid Diseases | Sleep Disorders

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205263
UMLS CUI [1,3]
C0015672
UMLS CUI [2]
C0040128
UMLS CUI [3]
C0851578
patients with other inflammatory diseases that affect cytokine levels.
Description

Inflammatory disorder Affecting Cytokine Level

Data type

boolean

Alias
UMLS CUI [1,1]
C1290884
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0079189
UMLS CUI [1,4]
C0441889
patients with a history of other cancers, and stage iv breast cancer.
Description

Malignant Neoplasms | Breast Carcinoma TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C3258246
patients undergoing current chemotherapy and/or radiotherapy.
Description

Chemotherapy | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
men with breast cancer.
Description

Gender Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0678222
substance abuse/dependence.
Description

Substance Use Disorders | Substance Dependence

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
continued use of another biofield-based intervention (e.g., reiki, qi-gong, healing touch, therapeutic touch, johrei).
Description

Biofield Therapy | Reiki | Qigong | Therapeutic tactile stimulation

Data type

boolean

Alias
UMLS CUI [1]
C1511139
UMLS CUI [2]
C0751715
UMLS CUI [3]
C0282077
UMLS CUI [4]
C0152054
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Similar models

Eligibility Breast Cancer NCT00440089

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age | Premenopausal state | Postmenopausal state
Item
premenopausal and postmenopausal women between the ages of 18 to 70 years.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0232969 (UMLS CUI [3])
C0232970 (UMLS CUI [4])
Informed Consent
Item
ability to give informed consent.
boolean
C0021430 (UMLS CUI [1])
Breast Carcinoma Survivors | Operative Surgical Procedures | Segmental Mastectomy | Simple mastectomy | Chemotherapy | Therapeutic radiology procedure
Item
breast cancer survivors who have undergone surgery, including lumpectomy and simple or total mastectomy, followed by chemotherapy or a combination of chemo- and radio-therapy. we have elected to study survivors instead of patients actively undergoing treatment to alleviate subject burden and risk during this protocol.
boolean
C0678222 (UMLS CUI [1,1])
C0206194 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2])
C0024885 (UMLS CUI [3])
C0024886 (UMLS CUI [4])
C0392920 (UMLS CUI [5])
C1522449 (UMLS CUI [6])
Breast Carcinoma TNM clinical staging Survivors
Item
stage i to iii breast cancer survivors.
boolean
C0678222 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0206194 (UMLS CUI [1,3])
Breast Carcinoma Survivors | Chemotherapy Completed | Therapeutic radiology procedure Completed
Item
breast cancer survivors who have finished their chemotherapy and/or radiotherapy at least one month prior to 60 months prior.
boolean
C0678222 (UMLS CUI [1,1])
C0206194 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
Breast Carcinoma Survivors | Fatigue Level Increased
Item
breast cancer survivors with above-normative levels of fatigue.
boolean
C0678222 (UMLS CUI [1,1])
C0206194 (UMLS CUI [1,2])
C0015672 (UMLS CUI [2,1])
C0441889 (UMLS CUI [2,2])
C0205217 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Therapeutic radiology procedure Breast Carcinoma | Chemotherapy Breast Carcinoma
Item
breast cancer patients who are currently receiving or who are scheduled to receive radiation or chemotherapy during the course of this intervention study.
boolean
C1522449 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
Major Depressive Disorder | Bipolar Disorder | Psychotropic Drugs
Item
patients with current major depression, current or history of prior bipolar illness, currently on psychotropic medications.
boolean
C1269683 (UMLS CUI [1])
C0005586 (UMLS CUI [2])
C0033978 (UMLS CUI [3])
Disease Inducing Fatigue | Thyroid Diseases | Sleep Disorders
Item
patients with other diseases that are known to induce fatigue (e.g., thyroid disorder; sleep disorders).
boolean
C0012634 (UMLS CUI [1,1])
C0205263 (UMLS CUI [1,2])
C0015672 (UMLS CUI [1,3])
C0040128 (UMLS CUI [2])
C0851578 (UMLS CUI [3])
Inflammatory disorder Affecting Cytokine Level
Item
patients with other inflammatory diseases that affect cytokine levels.
boolean
C1290884 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0079189 (UMLS CUI [1,3])
C0441889 (UMLS CUI [1,4])
Malignant Neoplasms | Breast Carcinoma TNM clinical staging
Item
patients with a history of other cancers, and stage iv breast cancer.
boolean
C0006826 (UMLS CUI [1])
C0678222 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
Chemotherapy | Therapeutic radiology procedure
Item
patients undergoing current chemotherapy and/or radiotherapy.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Gender Breast Carcinoma
Item
men with breast cancer.
boolean
C0079399 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
Substance Use Disorders | Substance Dependence
Item
substance abuse/dependence.
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
Biofield Therapy | Reiki | Qigong | Therapeutic tactile stimulation
Item
continued use of another biofield-based intervention (e.g., reiki, qi-gong, healing touch, therapeutic touch, johrei).
boolean
C1511139 (UMLS CUI [1])
C0751715 (UMLS CUI [2])
C0282077 (UMLS CUI [3])
C0152054 (UMLS CUI [4])
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