Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2026-02-23 @ 1:11 AM
Study NCT ID:
NCT02558257
Status:
COMPLETED
Last Update Posted:
2021-04-14
First Post:
2015-09-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perception of Palliative Care Encounter
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Perception of the Palliative Care Encounter by Patients Who Are Referred to Outpatient Supportive/ Palliative Care
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objectives:
Primary Objective The primary objective is to determine patients' perceptions of the timeliness of their referral to an outpatient palliative care clinic.
The secondary objectives are to determine:
1. The factors and variables associated with perception of timeliness such as age, gender, and symptom distress
2. The patients' perceptions of the physical environment of the outpatient clinic at UT MD Anderson Cancer Center (UTMDACC) such as lighting, music, and lack of a waiting room; and
3. If there is an association between level of distress (physical, psychological, and spiritual distress as measured by Edmonton Symptom Assessment Scale (ESAS) and the usefulness of the referral to palliative care center.
Primary Objective The primary objective is to determine patients' perceptions of the timeliness of their referral to an outpatient palliative care clinic.
The secondary objectives are to determine:
1. The factors and variables associated with perception of timeliness such as age, gender, and symptom distress
2. The patients' perceptions of the physical environment of the outpatient clinic at UT MD Anderson Cancer Center (UTMDACC) such as lighting, music, and lack of a waiting room; and
3. If there is an association between level of distress (physical, psychological, and spiritual distress as measured by Edmonton Symptom Assessment Scale (ESAS) and the usefulness of the referral to palliative care center.
Detailed Description:
If participant agrees to take part, they will complete 1 questionnaire over the phone, in person, or via e-mail about their first consultation experience, within 1 month after their visit. It should take about 15 minutes to complete. Health information about participant (such as their name, medical record number, telephone number, e-mail address, IP address, age, gender, race/ethnicity and cancer type) will also be collected but will not be shared with anyone outside of MD Anderson, except when required for regulatory purposes, or when required to be shared with study sponsors or study monitors. Participant's survey answers will not be shared with the Supportive Care staff.
Distress Plan:
Telephone - If participant experiences any distress while answering the survey questions, the research assistant will immediately contact our nurse in the Supportive Care Center. Participant will be contacted immediately to provide telephone counseling or address any other issue that may be causing distress. Our phone care nurse will offer participant to schedule a face-to-face visit with one of the Supportive Care physicians or to see a nurse in the Supportive Care Center.
In-person - If participant experiences significant and high levels of distress while participating in the study, we will refer participant to their primary care physician, physician in the Supportive Care Center or one of the supportive care counselors.
Online - If participant experiences significant and high levels of distress while completing the online survey, they may stop the survey and call the Supportive Care Center (during office hours) or the Supportive Care Mobile Team (after office hours or weekends). The contact information will be displayed on each page of the online survey.
Patient's participation on the study will be over after they have completed the questionnaire. Participant's de-identified study information will be kept by the Principal Investigator in a locked file cabinet and password protected electronic study database for 5 years after publication of the research and then destroyed. Online survey responses, demographics, e-mail address, and IP address will be stored indefinitely in a secured database by the Qualtrics team.
Distress Plan:
Telephone - If participant experiences any distress while answering the survey questions, the research assistant will immediately contact our nurse in the Supportive Care Center. Participant will be contacted immediately to provide telephone counseling or address any other issue that may be causing distress. Our phone care nurse will offer participant to schedule a face-to-face visit with one of the Supportive Care physicians or to see a nurse in the Supportive Care Center.
In-person - If participant experiences significant and high levels of distress while participating in the study, we will refer participant to their primary care physician, physician in the Supportive Care Center or one of the supportive care counselors.
Online - If participant experiences significant and high levels of distress while completing the online survey, they may stop the survey and call the Supportive Care Center (during office hours) or the Supportive Care Mobile Team (after office hours or weekends). The contact information will be displayed on each page of the online survey.
Patient's participation on the study will be over after they have completed the questionnaire. Participant's de-identified study information will be kept by the Principal Investigator in a locked file cabinet and password protected electronic study database for 5 years after publication of the research and then destroyed. Online survey responses, demographics, e-mail address, and IP address will be stored indefinitely in a secured database by the Qualtrics team.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2017-01598 | REGISTRY | NCI CTRP | View |