NCT05058339

Brief Summary

This study assesses the level of distress felt by cancer patients due to the coronavirus disease 2019 (COVID-19) pandemic. Researchers also want to learn if patients prefer to receive supportive care (palliative care) in person or through telemedicine (visits by phone or video call, such as Zoom). Information from this study may help doctors better understand how COVID-19 has affected patients with advanced cancer, patients' perceptions of telehealth, and may help clinicians tailor care to patients' needs during the pandemic.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
223

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 27, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 27, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

3.4 years

First QC Date

September 14, 2021

Last Update Submit

September 9, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Assessment of attitudes and beliefs of patients' level of distress and incidence of stressors due to the COVID-19 pandemic, measured by survey.

    \[Survey (COVID Distress Survey) will evaluate overall distress level with degree of increase or decrease assessed on a 7-point Likert scale, with higher scores indicating high distress levels.

    through study completion, an average of 1 year

  • Assessment of patients' overall preference and perceptions towards palliative telemedicine vs in person visits during the COVID-19 pandemic.

    \[Survey (Attitudes and beliefs towards telehealth) will evaluate participant preference level with degree of increase or decrease assessed by 5-point Likert scale from "strongly prefer virtual visits" to "strongly prefer in person visits", with high scores indicating preference for in-person visits..

    through study completion, an average of 1 year

Study Arms (1)

Observational (survey)

Patients complete survey over 20 minutes.

Other: Survey Administration

Interventions

Complete survey

Observational (survey)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with advanced cancer seen at the University of Texas MD Anderson Supportive Care Outpatient Clinic

You may qualify if:

  • Diagnosis of advanced cancer, defined as locally advanced, recurrent or metastatic disease
  • Age 18 or greater
  • Patient presenting for at least two follow-up visits with Supportive Care visit since the COVID19 pandemic (after March 23, 2020), consisting of either in-person, or virtual
  • For patients who have had two consecutive video visits, or consecutive telephone visits with supportive care, they will be asked to complete additional questions regarding telehealth visits

You may not qualify if:

  • Memorial Delirium Assessment Scale (MDAS) of 7 or more or if determined to be of impaired cognition by the clinician at the time of clinic visit as documented in the visit either by history or exam. Providers routinely note screening for mental status with routine administration of the MDAS or history of altered cognition or noted on exam
  • Non-English-speaking participants
  • Unwilling or unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

COVID-19Hematologic NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesNeoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David Hui, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2021

First Posted

September 27, 2021

Study Start

April 27, 2021

Primary Completion

September 6, 2024

Study Completion

September 6, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations