Advanced CancersNCT02558257
Perception of Palliative Care Encounter
An observational study of Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
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. 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?
- Survey
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 209 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2015to 7 Apr 2021
- Phase
- Observational
- 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
Study population: Participants who have undergone a consultation with a supportive Care doctor in the Supportive Care Center at The University of Texas MD Anderson Cancer Center in Houston, Texas.
Who may be able to join
- Have advanced cancer, defined as locally advanced, metastatic or incurable disease
- >/=18 years of age
- Seen at UTMDACC outpatient Supportive Care Center for consultation
- Provided informed consent
Who cannot join
- Memorial Delirium Assessment Scale (MDAS) >/= 13.
- Inability to read and speak English
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: Perception of the Palliative Care Encounter by Patients Who Are Referred to Outpatient Supportive/ Palliative Care
Objectives:
Primary Objective The primary objective is to determine patients' perceptions of the timeliness of their referral to an outpatient palliative care clinic.
Read more
The secondary objectives are to determine:
- The factors and variables associated with perception of timeliness such as age, gender, and symptom distress
- 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
- 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.
Read the 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.
- Conditions
- Advanced Cancers
- Being tested
- Survey
- Keywords
- Advanced Cancers, Survey, Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyBehavioural
Also called Questionnaire
Participants complete palliative care survey within 1 week +/- 4 days of initial consultation via phone survey conducted by Research nurse/assistant.
| Study group | Role | What they receive |
|---|---|---|
| Palliative Care Survey | Initial consultation visit followed by phone survey within 1 week +/- 4 days of initial consultation. Receives: Behavioral: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants' Perceptions of Timeliness of Referral to an Outpatient Palliative Care Clinic
Percentage of respondents who report that their referral to supportive care was late (including "late" and "too late") estimated with a standard error not larger than 0.04.
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 posted23 Sep 2015 (estimated)
- Study start16 Aug 2015
- Primary completion7 Apr 2021
- Study completion7 Apr 2021
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angelique N. Wong, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02558257
- Sponsor's protocol ID
- 2015-0578
- Other IDs
- NCI-2017-01598
- Status last verified
- Apr 2021
- First submitted
- 22 Sep 2015
- Last updated
- 14 Apr 2021
- 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 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perception of the Palliative Care Encounter by Patients Who Are Referred to Outpatient Supportive/ Palliative Care
- ClinicalTrials.gov ID
- NCT02558257
- Acronym / sponsor ID
- 2015-0578
- Conditions
- Advanced Cancers
- Keywords
- Advanced Cancers, Survey, Questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 16 Aug 2015 (actual)
- Primary completion
- 7 Apr 2021 (actual)
- Study completion
- 7 Apr 2021 (actual)
- First posted
- 23 Sep 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.
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:
- The factors and variables associated with perception of timeliness such as age, gender, and symptom distress
- 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
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Palliative Care Survey | – | Behavioral: SurveyInitial consultation visit followed by phone survey within 1 week +/- 4 days of initial consultation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who have undergone a consultation with a supportive Care doctor in the Supportive Care Center at The University of Texas MD Anderson Cancer Center in Houston, Texas.
Key inclusion criteria (4 listed)
- Have advanced cancer, defined as locally advanced, metastatic or incurable disease
- >/=18 years of age
- Seen at UTMDACC outpatient Supportive Care Center for consultation
- Provided informed consent
Key exclusion criteria (2 listed)
- Memorial Delirium Assessment Scale (MDAS) >/= 13.
- Inability to read and speak English
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 |
|---|---|---|
| SurveyAlso: QuestionnaireParticipants complete palliative care survey within 1 week +/- 4 days of initial consultation via phone survey conducted by Research nurse/assistant. | Behavioural | Palliative Care Survey |
Primary outcome
Participants' Perceptions of Timeliness of Referral to an Outpatient Palliative Care Clinic
Time frame: 1 day
Percentage of respondents who report that their referral to supportive care was late (including "late" and "too late") estimated with a standard error not larger than 0.04.
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 14 Apr 2021.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Angelique N. Wong, 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?
An observational study of 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 4 inclusion and 2 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 14 Apr 2021. 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?
Participants' Perceptions of Timeliness of Referral to an Outpatient Palliative Care Clinic (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 14 Apr 2021.