ID

35368

Description

Mindfulness Meditation Intervention for Colorectal Cancer Patients and Caregivers; ODM derived from: https://clinicaltrials.gov/show/NCT02423720

Link

https://clinicaltrials.gov/show/NCT02423720

Keywords

Versions (1)
  1. 3/3/19 3/3/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 3, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT02423720

English

Eligibility Colorectal Cancer NCT02423720

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
eligible patients must:
Description

Patient eligible for clinical trial

Data type

boolean

Alias
UMLS CUI [1]
C1302261
carry a diagnosis of metastatic colon, rectum, or small bowel adenocarcinoma
Description

Adenocarcinoma of colon metastatic | Adenocarcinoma of rectum metastatic | Adenocarcinoma of small intestine metastatic

Data type

boolean

Alias
UMLS CUI [1]
C4324497
UMLS CUI [2,1]
C0149978
UMLS CUI [2,2]
C1522484
UMLS CUI [3,1]
C0278803
UMLS CUI [3,2]
C1522484
anticipate receiving chemotherapy for at least 12 weeks total from the time of recruitment
Description

Chemotherapy Anticipated

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C3840775
have life expectancy of at least 6 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
have karnofsky performance status ≥60
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
be able to speak and read english
Description

Able to speak English Language | Able to read English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0586740
UMLS CUI [2,2]
C0376245
have access to a mobile phone
Description

Access Mobile Phone

Data type

boolean

Alias
UMLS CUI [1,1]
C0444454
UMLS CUI [1,2]
C1136360
be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet
Description

Navigation Web Site | Fill Out Form Web | Communication Email | Access Regular Internet

Data type

boolean

Alias
UMLS CUI [1,1]
C2827562
UMLS CUI [1,2]
C2349146
UMLS CUI [2,1]
C3273494
UMLS CUI [2,2]
C0282111
UMLS CUI [3,1]
C0009452
UMLS CUI [3,2]
C0013849
UMLS CUI [4,1]
C0444454
UMLS CUI [4,2]
C0205272
UMLS CUI [4,3]
C0282111
have a distress level of ≥3 on the nccn distress thermometer (dt).[1, 40]
Description

Distress Level NCCN Distress Thermometer

Data type

boolean

Alias
UMLS CUI [1,1]
C0700361
UMLS CUI [1,2]
C0441889
UMLS CUI [1,3]
C4321508
an effort will always be made to recruit patient and caregiver pairs, but unpaired patients are also eligible
Description

Recruitment Pair Patient Caregiver

Data type

boolean

Alias
UMLS CUI [1,1]
C2949735
UMLS CUI [1,2]
C1709450
UMLS CUI [1,3]
C0030705
UMLS CUI [1,4]
C0085537
eligible caregivers are a spouse/partner, other family member, or a close friend of a patient with metastatic colon, rectum, or small bowel adenocarcinoma.
Description

Caregiver Eligible | Spouse Patient | Partner Patient | Family member Patient | Close friend Patient

Data type

boolean

Alias
UMLS CUI [1,1]
C0085537
UMLS CUI [1,2]
C1548635
UMLS CUI [2,1]
C0162409
UMLS CUI [2,2]
C0030705
UMLS CUI [3,1]
C0682323
UMLS CUI [3,2]
C0030705
UMLS CUI [4,1]
C0086282
UMLS CUI [4,2]
C0030705
UMLS CUI [5,1]
C0682339
UMLS CUI [5,2]
C0030705
eligible caregivers must:
Description

Caregiver Eligible

Data type

boolean

Alias
UMLS CUI [1,1]
C0085537
UMLS CUI [1,2]
C1548635
be able to speak and read english
Description

Able to speak English Language | Able to read English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0586740
UMLS CUI [2,2]
C0376245
have access to a mobile phone
Description

Access Mobile Phone

Data type

boolean

Alias
UMLS CUI [1,1]
C0444454
UMLS CUI [1,2]
C1136360
be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet
Description

Navigation Web Site | Fill Out Form Web | Communication Email | Access Regular Internet

Data type

boolean

Alias
UMLS CUI [1,1]
C2827562
UMLS CUI [1,2]
C2349146
UMLS CUI [2,1]
C3273494
UMLS CUI [2,2]
C0282111
UMLS CUI [3,1]
C0009452
UMLS CUI [3,2]
C0013849
UMLS CUI [4,1]
C0444454
UMLS CUI [4,2]
C0205272
UMLS CUI [4,3]
C0282111
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
this study is limited the study to patients with metastatic colon, rectum, or small bowel adenocarcinoma, because treatment regimens and disease trajectories for these disease groups are similar.
Description

Patients Restricted Adenocarcinoma of colon metastatic | Patients Restricted Adenocarcinoma of rectum metastatic | Patients Restricted Adenocarcinoma of small intestine metastatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0443288
UMLS CUI [1,3]
C4324497
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0443288
UMLS CUI [2,3]
C0149978
UMLS CUI [2,4]
C1522484
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C0443288
UMLS CUI [3,3]
C0278803
UMLS CUI [3,4]
C1522484
deafness, current meditation practice (>2 episodes or >1 hour total, weekly), and current enrollment in a stress reduction program are exclusion criteria for the intervention study because the study is designed as an audio-based introduction to mindfulness meditation.
Description

Deafness | Participation in meditation Frequency | Stress reduction Program

Data type

boolean

Alias
UMLS CUI [1]
C0011053
UMLS CUI [2,1]
C1821915
UMLS CUI [2,2]
C0439603
UMLS CUI [3,1]
C0679002
UMLS CUI [3,2]
C3484370
patients with a dt level >7 will be considered on a case-by- case basis. patients and caregivers who participate in a focus group and meet criteria for the intervention will be given the opportunity to participate: data will be collected, but these patients/participants will not be included in the final analyses so as not to bias the results.
Description

Distress Level NCCN Distress Thermometer

Data type

boolean

Alias
UMLS CUI [1,1]
C0700361
UMLS CUI [1,2]
C0441889
UMLS CUI [1,3]
C4321508
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Similar models

Eligibility Colorectal Cancer NCT02423720

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Patient eligible for clinical trial
Item
eligible patients must:
boolean
C1302261 (UMLS CUI [1])
Adenocarcinoma of colon metastatic | Adenocarcinoma of rectum metastatic | Adenocarcinoma of small intestine metastatic
Item
carry a diagnosis of metastatic colon, rectum, or small bowel adenocarcinoma
boolean
C4324497 (UMLS CUI [1])
C0149978 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
C0278803 (UMLS CUI [3,1])
C1522484 (UMLS CUI [3,2])
Chemotherapy Anticipated
Item
anticipate receiving chemotherapy for at least 12 weeks total from the time of recruitment
boolean
C0392920 (UMLS CUI [1,1])
C3840775 (UMLS CUI [1,2])
Life Expectancy
Item
have life expectancy of at least 6 months
boolean
C0023671 (UMLS CUI [1])
Karnofsky Performance Status
Item
have karnofsky performance status ≥60
boolean
C0206065 (UMLS CUI [1])
Able to speak English Language | Able to read English Language
Item
be able to speak and read english
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0586740 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
Access Mobile Phone
Item
have access to a mobile phone
boolean
C0444454 (UMLS CUI [1,1])
C1136360 (UMLS CUI [1,2])
Navigation Web Site | Fill Out Form Web | Communication Email | Access Regular Internet
Item
be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet
boolean
C2827562 (UMLS CUI [1,1])
C2349146 (UMLS CUI [1,2])
C3273494 (UMLS CUI [2,1])
C0282111 (UMLS CUI [2,2])
C0009452 (UMLS CUI [3,1])
C0013849 (UMLS CUI [3,2])
C0444454 (UMLS CUI [4,1])
C0205272 (UMLS CUI [4,2])
C0282111 (UMLS CUI [4,3])
Distress Level NCCN Distress Thermometer
Item
have a distress level of ≥3 on the nccn distress thermometer (dt).[1, 40]
boolean
C0700361 (UMLS CUI [1,1])
C0441889 (UMLS CUI [1,2])
C4321508 (UMLS CUI [1,3])
Recruitment Pair Patient Caregiver
Item
an effort will always be made to recruit patient and caregiver pairs, but unpaired patients are also eligible
boolean
C2949735 (UMLS CUI [1,1])
C1709450 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,3])
C0085537 (UMLS CUI [1,4])
Caregiver Eligible | Spouse Patient | Partner Patient | Family member Patient | Close friend Patient
Item
eligible caregivers are a spouse/partner, other family member, or a close friend of a patient with metastatic colon, rectum, or small bowel adenocarcinoma.
boolean
C0085537 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C0162409 (UMLS CUI [2,1])
C0030705 (UMLS CUI [2,2])
C0682323 (UMLS CUI [3,1])
C0030705 (UMLS CUI [3,2])
C0086282 (UMLS CUI [4,1])
C0030705 (UMLS CUI [4,2])
C0682339 (UMLS CUI [5,1])
C0030705 (UMLS CUI [5,2])
Caregiver Eligible
Item
eligible caregivers must:
boolean
C0085537 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
Able to speak English Language | Able to read English Language
Item
be able to speak and read english
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0586740 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
Access Mobile Phone
Item
have access to a mobile phone
boolean
C0444454 (UMLS CUI [1,1])
C1136360 (UMLS CUI [1,2])
Navigation Web Site | Fill Out Form Web | Communication Email | Access Regular Internet
Item
be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet
boolean
C2827562 (UMLS CUI [1,1])
C2349146 (UMLS CUI [1,2])
C3273494 (UMLS CUI [2,1])
C0282111 (UMLS CUI [2,2])
C0009452 (UMLS CUI [3,1])
C0013849 (UMLS CUI [3,2])
C0444454 (UMLS CUI [4,1])
C0205272 (UMLS CUI [4,2])
C0282111 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Patients Restricted Adenocarcinoma of colon metastatic | Patients Restricted Adenocarcinoma of rectum metastatic | Patients Restricted Adenocarcinoma of small intestine metastatic
Item
this study is limited the study to patients with metastatic colon, rectum, or small bowel adenocarcinoma, because treatment regimens and disease trajectories for these disease groups are similar.
boolean
C0030705 (UMLS CUI [1,1])
C0443288 (UMLS CUI [1,2])
C4324497 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C0443288 (UMLS CUI [2,2])
C0149978 (UMLS CUI [2,3])
C1522484 (UMLS CUI [2,4])
C0030705 (UMLS CUI [3,1])
C0443288 (UMLS CUI [3,2])
C0278803 (UMLS CUI [3,3])
C1522484 (UMLS CUI [3,4])
Deafness | Participation in meditation Frequency | Stress reduction Program
Item
deafness, current meditation practice (>2 episodes or >1 hour total, weekly), and current enrollment in a stress reduction program are exclusion criteria for the intervention study because the study is designed as an audio-based introduction to mindfulness meditation.
boolean
C0011053 (UMLS CUI [1])
C1821915 (UMLS CUI [2,1])
C0439603 (UMLS CUI [2,2])
C0679002 (UMLS CUI [3,1])
C3484370 (UMLS CUI [3,2])
Distress Level NCCN Distress Thermometer
Item
patients with a dt level >7 will be considered on a case-by- case basis. patients and caregivers who participate in a focus group and meet criteria for the intervention will be given the opportunity to participate: data will be collected, but these patients/participants will not be included in the final analyses so as not to bias the results.
boolean
C0700361 (UMLS CUI [1,1])
C0441889 (UMLS CUI [1,2])
C4321508 (UMLS CUI [1,3])
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