Advanced CancersNCT02523378
Edmonton Symptom Assessment Scale: Self-Completion vs. Assisted-Completion
A study testing Edmonton Symptom Assessment Scale and Interview in people with Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this research study is to learn how easy participants think it is to complete a symptom questionnaire. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancers
- What is being tested?
- Edmonton Symptom Assessment Scale and Interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2015to 3 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: 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.
Read the 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.
- Conditions
- Advanced Cancers
- Being tested
- Edmonton Symptom Assessment Scale, Interview
- Keywords
- Advanced Cancers, Recurrent, Locally advanced, Metastatic, Edmonton Symptom Assessment Scale, ESAS, Survey, Interview, Symptom questionnaire
- Medical subject headings
- Recurrence, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edmonton Symptom Assessment ScaleBehavioural
Also called Survey, Questionnaire
Participants complete the symptom survey alone, or with the help of a research nurse or assistant.
InterviewBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ESAS Self-Administration - Group A | Experimental | Participants complete the symptom questionnaire alone. It is then counterchecked by health care professional (HCP). Receives: Behavioral: Edmonton Symptom Assessment Scale; Behavioral: Interview |
| ESAS Assisted-Completion - Group B | Experimental | Participants complete the symptom questionnaire with the help of the research nurse or assistant. Receives: Behavioral: Edmonton Symptom Assessment Scale; Behavioral: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study start13 Aug 2015
- Primary completion3 Dec 2020
- Study completion3 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancersStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eduardo Bruera, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02523378
- Sponsor's protocol ID
- 2015-0284
- Other IDs
- NCI-2015-01441
- Status last verified
- Dec 2020
- First submitted
- 11 Aug 2015
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Edmonton Symptom Assessment Scale: Time Duration of Self-Completion Versus Assisted-Completion in Advanced Cancer Patient: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02523378
- Acronym / sponsor ID
- 2015-0284
- Conditions
- Advanced Cancers
- Keywords
- Advanced Cancers, Recurrent, Locally advanced, Metastatic, Edmonton Symptom Assessment Scale, ESAS, Survey, Interview
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 13 Aug 2015 (actual)
- Primary completion
- 3 Dec 2020 (actual)
- Study completion
- 3 Dec 2020 (actual)
- First posted
- 14 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESAS Self-Administration - Group A | Experimental | Behavioral: Edmonton Symptom Assessment Scale, Behavioral: InterviewParticipants complete the symptom questionnaire alone. It is then counterchecked by health care professional (HCP). |
| ESAS Assisted-Completion - Group B | Experimental | Behavioral: Edmonton Symptom Assessment Scale, Behavioral: InterviewParticipants complete the symptom questionnaire with the help of the research nurse or assistant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Edmonton Symptom Assessment ScaleAlso: Survey, QuestionnaireParticipants complete the symptom survey alone, or with the help of a research nurse or assistant. | Behavioural | ESAS Assisted-Completion - Group B, ESAS Self-Administration - Group A |
| InterviewAfter 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. | Behavioural | ESAS Assisted-Completion - Group B, ESAS Self-Administration - Group A |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Advanced Cancers
RecruitingPhase 2
Study to Assess the Efficacy and Safety of Rina-S in Participants With Advanced Gastrointestinal (GI) Cancers
Gastrointestinal Cancers
RecruitingPhase 2
A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer
Carcinoma, Non-small-Cell Lung
RecruitingPhase 1
A Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors
Advanced Stage Solid Tumors
RecruitingPhase 1
A Study of JNJ-98768111 in Participants With Advanced Prostate Cancer
Prostatic Neoplasms
Active, not recruiting
Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer
Bone Metastases, HER2-positive Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo Bruera, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Edmonton Symptom Assessment Scale and Interview in people with Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2020; AzTrials last refreshed its copy on 3 Nov 2026.