Edmonton Symptom Assessment Scale: Self-Completion vs. Assisted-Completion
2 other identifiers
interventional
138
1 country
1
Brief Summary
The goal of this research study is to learn how easy participants think it is to complete a symptom questionnaire.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2015
CompletedStudy Start
First participant enrolled
August 13, 2015
CompletedFirst Posted
Study publicly available on registry
August 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 3, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 3, 2020
CompletedDecember 21, 2020
December 1, 2020
5.3 years
August 11, 2015
December 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
ESAS Self-Administration - Group A
EXPERIMENTALParticipants complete the symptom questionnaire alone. It is then counterchecked by health care professional (HCP).
ESAS Assisted-Completion - Group B
EXPERIMENTALParticipants complete the symptom questionnaire with the help of the research nurse or assistant.
Interventions
Participants complete the symptom survey alone, or with the help of a research nurse or assistant.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eduardo Bruera, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2015
First Posted
August 14, 2015
Study Start
August 13, 2015
Primary Completion
December 3, 2020
Study Completion
December 3, 2020
Last Updated
December 21, 2020
Record last verified: 2020-12