Edmonton Symptom Assessment Scale: Self-Completion vs. Assisted-Completion
NCT ID: NCT02523378
Last Updated: 2020-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
138 participants
INTERVENTIONAL
2015-08-13
2020-12-03
Brief Summary
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Detailed Description
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Participant will also be given a list of words and asked to read them out loud. The research nurse or assistant will write down if participant pronounced the words correctly. This should take up to 7 minutes.
Participant will then be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group.
* If participant is enrolled in Group 1, they will complete the symptom questionnaire alone and then a research nurse or assistant will go over their answers with them.
* If participant is enrolled in Group 2, they will complete the symptom questionnaire with the help of the research nurse or assistant.
After participant has completed the symptom questionnaire, they will be asked if they preferred completing the questionnaire alone or if they preferred to have a nurse help them answer the questions. This should take about 1 minute to answer.
Length of Study:
It should take about 15 minutes total to complete the study. Patient's participation on this study will end after they have completed the symptom questionnaire.
Additional Information:
Participant is taking part in this study alone. Participant's family members will not be in the room with them.
This is an investigational study.
Up to 128 participants will be enrolled in the study. All will take part at MD Anderson.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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ESAS Self-Administration - Group A
Participants complete the symptom questionnaire alone. It is then counterchecked by health care professional (HCP).
Edmonton Symptom Assessment Scale
Participants complete the symptom survey alone, or with the help of a research nurse or assistant.
Interview
After completion of the symptom questionnaire, participants asked if they preferred completing the questionnaire alone, or if they preferred to have a nurse help them answer the questions.
ESAS Assisted-Completion - Group B
Participants complete the symptom questionnaire with the help of the research nurse or assistant.
Edmonton Symptom Assessment Scale
Participants complete the symptom survey alone, or with the help of a research nurse or assistant.
Interview
After completion of the symptom questionnaire, participants asked if they preferred completing the questionnaire alone, or if they preferred to have a nurse help them answer the questions.
Interventions
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Edmonton Symptom Assessment Scale
Participants complete the symptom survey alone, or with the help of a research nurse or assistant.
Interview
After completion of the symptom questionnaire, participants asked if they preferred completing the questionnaire alone, or if they preferred to have a nurse help them answer the questions.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients must know their cancer diagnosis
3. Patients referred for consultation to the Supportive Care team
4. Age \>/= 18
5. Patients must be able to understand, read, write, and speak English
6. Patients have never done the ESAS before
7. Patients must sign an informed consent
8. Ability to independently complete the study as assessed by the research staff
Exclusion Criteria
2. Patients who have already done the ESAS in the past.
3. Patients who are considered to be in severe physical or emotional distress based on the assessment by the research staff
4. Patients who refuse to participate in the study.
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Eduardo Bruera, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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University of Texas MD Anderson Cancer Center Website
Other Identifiers
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NCI-2015-01441
Identifier Type: REGISTRY
Identifier Source: secondary_id
2015-0284
Identifier Type: -
Identifier Source: org_study_id