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

Advanced Cancers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02523378
• Other study ID #: 2015-0284
• Secondary ID: NCI-2015-01441
• Status: Completed
• Phase: N/A
• Start date: August 13, 2015
• Est. completion date: December 3, 2020

Study information

• Verified date: December 2020
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: December 3, 2020
• Est. primary completion date: December 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Cancers
• Neoplasms

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   University of Texas MD Anderson Cancer Center Website