NCT04652505

Brief Summary

This study determines how the threat of the coronavirus has affected the mental health and physical well-being of cancer patients seen at the psychiatric oncology clinic, and how they have coped with any related stress. Questionnaires that assess coping strategies and behaviors for decreasing disease transmission may help researchers create recommendations for future public health crises and pandemics.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

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

July 13, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 3, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2022

Completed
Last Updated

January 14, 2022

Status Verified

January 1, 2022

Enrollment Period

1.5 years

First QC Date

September 11, 2020

Last Update Submit

January 13, 2022

Conditions

COVID-19 InfectionHematopoietic and Lymphoid Cell NeoplasmMalignant Solid Neoplasm

Outcome Measures

Primary Outcomes (3)

  • Patient-reported severity of depression

    sum score on the Patient Health Questionnaire, a 9-item scale with a sumscore ranging between 0 and 27, with a higher score indicating more-severe depression.

    Baseline

  • Patient-reported severity of anxiety

    sum score on the generalized anxiety disorder questionnaire, a 7-item scale with sumscore range between 0 and 21. A higher score indicates higher severity of anxiety.

    Baseline

  • Patient-reported severity of distress

    score on the National Comprehensive Cancer Network Distress Thermometer, a one-item 0-10 scale. A higher score indicates higher distress.

    Baseline

Secondary Outcomes (5)

  • Patient-reported physical symptoms

    Baseline

  • Substance use

    Baseline

  • Patient-reported coping strategy

    Baseline

  • Patient-reported levels of apathy

    Baseline

  • Patient-reported engagement in the 5 health behaviors endorsed by World Health Organization intended to curb the spread of the coronavirus

    Baseline

Study Arms (1)

Observational (questionnaires)

Patients complete 3 questionnaires online over 15 minutes regarding coping strategies that may have been used, mental health and physical well-being in the past month, and if they have been following certain behaviors which the WHO has recommended during the coronavirus pandemic, such as regular hand washing and social distancing.

Other: Questionnaire Administration

Interventions

Questionnaire AdministrationOTHER

Complete questionnaires

Observational (questionnaires)

Eligibility Criteria

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

Cancer patients who received care at the psychiatric oncology clinic during the COVID-19 pandemic

You may qualify if:

  • Outpatients seen by providers of the psychiatric oncology clinic at least once between November 1, 2019 and February 29, 2020 and at least once between April 10, 2020 and June 10, 2020
  • Speaking English as indicated in their medical chart

You may not qualify if:

  • Patients who are pregnant as recorded in their medical chart
  • Incarcerated
  • With a recorded diagnosis of a formal thought disorder
  • Unable to 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 Neoplasms

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesNeoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Tamara E Lacourt

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 11, 2020

First Posted

December 3, 2020

Study Start

July 13, 2020

Primary Completion

January 12, 2022

Study Completion

January 12, 2022

Last Updated

January 14, 2022

Record last verified: 2022-01

Locations

US(1)