Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02558257 |
| Other study ID # |
2015-0578 |
| Secondary ID |
NCI-2017-01598 |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 16, 2015 |
| Est. completion date |
April 7, 2021 |
Study information
| Verified date |
April 2021 |
| Source |
M.D. Anderson Cancer Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
