Clinical trial NCT05058339: Distress Associated with Coronavirus Disease 2019 and Telehealth on Supportive Care Patients with Advanced Cancer
Official title: Distress Associated with Coronavirus Disease 2019 and Telehealth on Supportive Care Patients with Advanced Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Malignant Solid Neoplasm
COVID-19 Infection
Hematopoietic and Lymphoid Cell Neoplasm
Locally Advanced Malignant Solid Neoplasm
Metastatic Malignant Solid Neoplasm
Recurrent Hematologic Malignancy
Recurrent Malignant Solid Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-09-27
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced cancer seen at the University of Texas MD Anderson Supportive Care Outpatient Clinic

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of attitudes and beliefs of patients' level of distress and incidence of stressors due to the COVID-19 pandemic, measured by survey.
timeFrame: through study completion, an average of 1 year
measure: Assessment of patients' overall preference and perceptions towards palliative telemedicine vs in person visits during the COVID-19 pandemic.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: David Hui, MD
role: PRINCIPAL_INVESTIGATOR
References: