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

Active, not recruiting

• Conditions: Locally Advanced Malignant Solid Neoplasm; Hematopoietic and Lymphoid Cell Neoplasm; Metastatic Malignant Solid Neoplasm; Advanced Malignant Solid Neoplasm; COVID-19 Infection; Recurrent Hematologic Malignancy; Recurrent Malignant Solid Neoplasm
• Interventions: Other: Survey Administration

• Registration Number: NCT05058339
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-04-27
• Study First Submitted: 2021-09-14
• Study First Submitted QC: 2021-09-24
• Study First Posted: 2021-09-27
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-27
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 223

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (survey)	Survey Administration	Patients complete survey over 20 minutes.

Primary Outcome Measures

Name	Time	Method
Assessment of attitudes and beliefs of patients' level of distress and incidence of stressors due to the COVID-19 pandemic, measured by survey.	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.
Assessment of patients' overall preference and perceptions towards palliative telemedicine vs in person visits during the COVID-19 pandemic.	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..

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States