Edmonton Symptom Assessment Scale: Time Duration of Self-Completion Versus Assisted-Completion in Advanced Cancer Patient: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 138
- Locations
- 1
- Primary Endpoint
- 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)
Study Overview
Brief Summary
The goal of this research study is to learn how easy participants think it is to complete a symptom questionnaire.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
ESAS Self-Administration - Group A
Participants complete the symptom questionnaire alone. It is then counterchecked by health care professional (HCP).
Intervention: Edmonton Symptom Assessment Scale (Behavioral)
ESAS Self-Administration - Group A
Participants complete the symptom questionnaire alone. It is then counterchecked by health care professional (HCP).
Intervention: Interview (Behavioral)
ESAS Assisted-Completion - Group B
Participants complete the symptom questionnaire with the help of the research nurse or assistant.
Intervention: Edmonton Symptom Assessment Scale (Behavioral)
ESAS Assisted-Completion - Group B
Participants complete the symptom questionnaire with the help of the research nurse or assistant.
Intervention: Interview (Behavioral)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported