Overview

This trial is active, not recruiting.

Condition advanced cancers
Treatment survey
Sponsor M.D. Anderson Cancer Center
Start date October 2015
End date October 2018
Trial size 209 participants
Trial identifier NCT02558257, 2015-0578

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Initial consultation visit followed by phone survey within 1 week +/- 4 days of initial consultation.
survey Questionnaire
Participants complete palliative care survey within 1 week +/- 4 days of initial consultation via phone survey conducted by Research nurse/assistant.

Primary Outcomes

Measure
Participants' Perceptions of Timeliness of Referral to an Outpatient Palliative Care Clinic
time frame: 1 day

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Have advanced cancer, defined as locally advanced, metastatic or incurable disease 2. >/=18 years of age 3. Seen at UTMDACC outpatient Supportive Care Center for consultation 4. Provided informed consent Exclusion Criteria: 1. Memorial Delirium Assessment Scale (MDAS) >/= 13. 2. Inability to read and speak English

Additional Information

Official title Perception of the Palliative Care Encounter by Patients Who Are Referred to Outpatient Supportive/ Palliative Care
Principal investigator Angelique N. Wong, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.