ID

39252

Beschreibung

A Randomized, Controlled Trial to Determine the Effects of an Exercise Intervention on Physical Activity During Chemotherapy for Patients With Early Stage Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02159157

Link

https://clinicaltrials.gov/show/NCT02159157

Stichworte

Versionen (1)
  1. 12.12.19 12.12.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

12. Dezember 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Early Stage Breast Cancer NCT02159157

Englisch

Eligibility Early Stage Breast Cancer NCT02159157

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. women or men with histologically confirmed breast cancer and no evidence of metastatic disease with a recommendation to begin chemotherapy within 4 weeks.
Beschreibung

Gender | Breast Carcinoma | Neoplasm Metastasis Absent | Recommendation Chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0678222
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0034866
UMLS CUI [4,2]
C0392920
2. patients must have recovered from prior surgery.
Beschreibung

Prior surgery Patient recovered

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0455610
UMLS CUI [1,2]
C1115804
3. patients must be able to walk unassisted without oxygen
Beschreibung

Able to walk Without Help | Able to walk Without Oxygen support

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2712089
UMLS CUI [1,2]
C3827452
UMLS CUI [2,1]
C2712089
UMLS CUI [2,2]
C0332288
UMLS CUI [2,3]
C3872899
4. patients must complete the physical activity readiness questionnaire with "no" answers to all questions; if patient responds with yes answers, or is over age 69, approval must be obtained from the patient's primary care physician or treating medical oncologist to participate in the study.
Beschreibung

Physical activity questionnaire Completion | Age

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4264334
UMLS CUI [1,2]
C0205197
UMLS CUI [2]
C0001779
5. able to fast for 12 hours for blood work and basal metabolic rate measurement.
Beschreibung

Fasting Duration Able | Hematologic Test | Measurement of basal metabolic rate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015663
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C0085732
UMLS CUI [2]
C0018941
UMLS CUI [3]
C0542499
6. karnofsky performance status > or = to 80%.
Beschreibung

Karnofsky Performance Status

Datentyp

boolean

Alias
UMLS CUI [1]
C0206065
7. previous or ongoing physical therapy treatments are acceptable.
Beschreibung

Physical therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0949766
8. participants may be enrolled on other treatment-based clinical trials but may not be enrolled on any other weight loss trials.
Beschreibung

Study Subject Participation Status | Therapies, Investigational | Weight loss Clinical Trial Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0949266
UMLS CUI [3,1]
C1262477
UMLS CUI [3,2]
C0008976
UMLS CUI [3,3]
C0332197
9. participants must have a baseline activity level of < 150 minutes/wk of moderate to vigorous activity as calculated using the moderate to vigorous components of the lteq (leisure time exercise questionnaire) for physical activity (completed during screening).
Beschreibung

Moderate physical activity minutes per week | Vigorous physical activity minutes per week | Leisure Time Exercise Questionnaires

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4482418
UMLS CUI [1,2]
C0556975
UMLS CUI [2,1]
C4267713
UMLS CUI [2,2]
C0556975
UMLS CUI [3,1]
C0086542
UMLS CUI [3,2]
C0015259
UMLS CUI [3,3]
C0034394
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients less than 18 years of age.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. patients with history of acute mi (myocardial infarction) or cva (cerebral vascular accident) within the last 12 months.
Beschreibung

Acute myocardial infarction | Cerebrovascular accident Recent

Datentyp

boolean

Alias
UMLS CUI [1]
C0155626
UMLS CUI [2,1]
C0038454
UMLS CUI [2,2]
C0332185
3. patients who are oxygen dependent.
Beschreibung

Patient dependence on Oxygen support

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0439857
UMLS CUI [1,2]
C3872899
4. patients unable to give informed consent indicating they are aware of the investigational nature of this intervention prior to entry into the study.
Beschreibung

Informed Consent Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
5. patients with a karnofsky performance status of < 80%.
Beschreibung

Karnofsky Performance Status

Datentyp

boolean

Alias
UMLS CUI [1]
C0206065
6. pregnant.
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
7. unable to read or write in english.
Beschreibung

Lacking Able to read English Language | Lacking Able to write English Language

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0586740
UMLS CUI [1,3]
C0376245
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C0584993
UMLS CUI [2,3]
C0376245
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Ähnliche Modelle

Eligibility Early Stage Breast Cancer NCT02159157

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Breast Carcinoma | Neoplasm Metastasis Absent | Recommendation Chemotherapy
Item
1. women or men with histologically confirmed breast cancer and no evidence of metastatic disease with a recommendation to begin chemotherapy within 4 weeks.
boolean
C0079399 (UMLS CUI [1])
C0678222 (UMLS CUI [2])
C0027627 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0034866 (UMLS CUI [4,1])
C0392920 (UMLS CUI [4,2])
Prior surgery Patient recovered
Item
2. patients must have recovered from prior surgery.
boolean
C0455610 (UMLS CUI [1,1])
C1115804 (UMLS CUI [1,2])
Able to walk Without Help | Able to walk Without Oxygen support
Item
3. patients must be able to walk unassisted without oxygen
boolean
C2712089 (UMLS CUI [1,1])
C3827452 (UMLS CUI [1,2])
C2712089 (UMLS CUI [2,1])
C0332288 (UMLS CUI [2,2])
C3872899 (UMLS CUI [2,3])
Physical activity questionnaire Completion | Age
Item
4. patients must complete the physical activity readiness questionnaire with "no" answers to all questions; if patient responds with yes answers, or is over age 69, approval must be obtained from the patient's primary care physician or treating medical oncologist to participate in the study.
boolean
C4264334 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
Fasting Duration Able | Hematologic Test | Measurement of basal metabolic rate
Item
5. able to fast for 12 hours for blood work and basal metabolic rate measurement.
boolean
C0015663 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0018941 (UMLS CUI [2])
C0542499 (UMLS CUI [3])
Karnofsky Performance Status
Item
6. karnofsky performance status > or = to 80%.
boolean
C0206065 (UMLS CUI [1])
Physical therapy
Item
7. previous or ongoing physical therapy treatments are acceptable.
boolean
C0949766 (UMLS CUI [1])
Study Subject Participation Status | Therapies, Investigational | Weight loss Clinical Trial Absent
Item
8. participants may be enrolled on other treatment-based clinical trials but may not be enrolled on any other weight loss trials.
boolean
C2348568 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
C1262477 (UMLS CUI [3,1])
C0008976 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Moderate physical activity minutes per week | Vigorous physical activity minutes per week | Leisure Time Exercise Questionnaires
Item
9. participants must have a baseline activity level of < 150 minutes/wk of moderate to vigorous activity as calculated using the moderate to vigorous components of the lteq (leisure time exercise questionnaire) for physical activity (completed during screening).
boolean
C4482418 (UMLS CUI [1,1])
C0556975 (UMLS CUI [1,2])
C4267713 (UMLS CUI [2,1])
C0556975 (UMLS CUI [2,2])
C0086542 (UMLS CUI [3,1])
C0015259 (UMLS CUI [3,2])
C0034394 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Age
Item
1. patients less than 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Acute myocardial infarction | Cerebrovascular accident Recent
Item
2. patients with history of acute mi (myocardial infarction) or cva (cerebral vascular accident) within the last 12 months.
boolean
C0155626 (UMLS CUI [1])
C0038454 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Patient dependence on Oxygen support
Item
3. patients who are oxygen dependent.
boolean
C0439857 (UMLS CUI [1,1])
C3872899 (UMLS CUI [1,2])
Informed Consent Unable
Item
4. patients unable to give informed consent indicating they are aware of the investigational nature of this intervention prior to entry into the study.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Karnofsky Performance Status
Item
5. patients with a karnofsky performance status of < 80%.
boolean
C0206065 (UMLS CUI [1])
Pregnancy
Item
6. pregnant.
boolean
C0032961 (UMLS CUI [1])
Lacking Able to read English Language | Lacking Able to write English Language
Item
7. unable to read or write in english.
boolean
C0332268 (UMLS CUI [1,1])
C0586740 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
C0332268 (UMLS CUI [2,1])
C0584993 (UMLS CUI [2,2])
C0376245 (UMLS CUI [2,3])
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