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

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

Detailed Description
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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.

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

Conditions
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Advanced Cancers

Intervention / Treatment
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* Behavioral: Edmonton Symptom Assessment Scale
* Behavioral: Interview


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a diagnosis of advanced cancer, including recurrent, locally advanced, or metastatic cancer Patients must know their cancer diagnosis Patients referred for consultation to the Supportive Care team Age >/= 18 Patients must be able to understand, read, write, and speak English Patients have never done the ESAS before Patients must sign an informed consent Ability to independently complete the study as assessed by the research staff Exclusion Criteria: Patients who have clinical evidence of cognitive impairment as determined by the research staff Patients who have already done the ESAS in the past. Patients who are considered to be in severe physical or emotional distress based on the assessment by the research staff Patients who refuse to participate in the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESAS Self-Administration - Group A<br>Participants complete the symptom questionnaire alone. It is then counterchecked by health care professional (HCP). | Behavioral: Edmonton Symptom Assessment Scale<br>* Participants complete the symptom survey alone, or with the help of a research nurse or assistant.<br>* Other names: Questionnaire;Behavioral: Interview<br>* 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.<br>|
| Experimental: ESAS Assisted-Completion - Group B<br>Participants complete the symptom questionnaire with the help of the research nurse or assistant. | Behavioral: Edmonton Symptom Assessment Scale<br>* Participants complete the symptom survey alone, or with the help of a research nurse or assistant.<br>* Other names: Questionnaire;Behavioral: Interview<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Duration of Self-Completion of Edmonton Symptom Assessment Scale (ESAS) by Advanced Cancer Participants (ACP) vs. Assisted-Completion with a Health Care Professional (HCP) | Two group t-test used with significance level of 5%, a total of 128 patients (64 patients/group) will give 80% power to detect the difference of 1.5 minutes (4 minutes in Group A vs 5.5 minutes in Group B) in overall time, given a common standard deviation of 3, which corresponds to an effect size of 0.5. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced Cancers, Recurrent, Locally advanced, Metastatic, Edmonton Symptom Assessment Scale, ESAS, Survey, Interview, Symptom questionnaire