Edmonton Symptom Assessment Scale: Self-Completion vs. Assisted-Completion



Status:Active, not recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:9/29/2018
Start Date:August 13, 2015
End Date:August 31, 2019

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Edmonton Symptom Assessment Scale: Time Duration of Self-Completion Versus Assisted-Completion in Advanced Cancer Patient: a Randomized Controlled Trial

The goal of this research study is to learn how easy participants think it is to complete a
symptom questionnaire.

If participant agrees to take part in the study, basic information about them will be
collected from their medical record (such as their age, gender, ethnicity, religion,
diagnosis, marital status, educational level, performance status, and any drugs they may have
taken in the past or are currently taking).

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.

Inclusion Criteria:

1. Patients with a diagnosis of advanced cancer, including recurrent, locally advanced,
or metastatic cancer

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:

1. Patients who have clinical evidence of cognitive impairment as determined by the
research staff

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.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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mi
from
Houston, TX
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