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OpenTrials
Completed

NCT Number: NCT05058339

Distress Associated with Coronavirus Disease 2019 and Telehealth on Supportive Care Patients with Advanced Cancer

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.

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Key information

About this study

PRIMARY OBJECTIVES:

I. Assess advanced cancer patients' level of distress due to the COVID-19 pandemic.

II. Assess patients' overall preference towards palliative telemedicine vs in person visits during the COVID-19 pandemic.

SECONDARY OBJECTIVES:

I. Assess associations between patient characteristics and perceptions of overall distress due to the COVID-19 pandemic.

II. Assess associations between patient characteristics and their attitudes and beliefs towards palliative telemedicine during the COVID-19 pandemic.

III. Compare the attitudes and beliefs towards palliative telemedicine between patients who completed visits via video vs telephone.

OUTLINE:

Patients complete survey over 20 minutes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Survey Administration

Other

Complete survey

Primary outcomes

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

    Time frame: through study completion, an average of 1 year

    [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.

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

    Time frame: through study completion, an average of 1 year

    [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..

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 27, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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