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

December 18, 2020 updated by: M.D. Anderson Cancer Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

138

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

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)
Time Frame: 1 day
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 13, 2015

Primary Completion (Actual)

December 3, 2020

Study Completion (Actual)

December 3, 2020

Study Registration Dates

First Submitted

August 11, 2015

First Submitted That Met QC Criteria

August 12, 2015

First Posted (Estimate)

August 14, 2015

Study Record Updates

Last Update Posted (Actual)

December 21, 2020

Last Update Submitted That Met QC Criteria

December 18, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-0284
  • NCI-2015-01441 (Registry Identifier: NCI CTRP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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