Clinical trial NCT04447222: Impact of the COVID-19 Pandemic and HRQOL in Cancer Patients and Survivors
Official title: COVID-19: Well-Being and HRQOL in Cancer Patients Who Participated in Prior Behavioral Clinical Trials
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: COVID-19 Infection
Malignant Solid Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-06-25
Enrollment: 1242
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cancer who have participated in prior behavioral clinical trials.

Brief summary: This study uses questionnaires to gain an understanding of how experiences during the COVID-19 pandemic, regardless of COVID-19 status, may have impacted health-related quality of life (HRQOL) and other areas such as COVID-19-specific psychological distress, disruptions to health care, finances and social interactions in cancer patients. The coronavirus disease 2019 (COVID-19) is an infectious disease that is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The information learned from this study will guide the development of psychosocial programs to improve patient care and outcomes in cancer patients and survivors in the context of facing a global pandemic.

Detailed description: PRIMARY OBJECTIVES:

I. Assess experiences during the coronavirus disease-2019 (COVID-19) pandemic (e.g., exposure, risk factors, testing, isolation, seropositivity, hospitalization, loss of family or friends); COVID-19-specific psychological distress (e.g., fear, anxiety and depressive symptoms); health, financial and social disruptions; perceived benefits and social support; and HRQoL and other psychosocial and behavioral factors in cancer survivors who participated in one of three prior clinical trials.

II. Evaluate the extent to which COVID-19 experiences are associated with COVID-19 specific psychological distress, health, financial and social disruptions, perceived benefits and social support, and HRQoL.

III. Evaluate the extent to which resiliency factors such as social support and perceived benefits assessed concurrently and other psychosocial measures assessed in the prior trials moderate the effects of COVID-19 experiences on COVID-19-specific psychological distress and HRQoL.

IV. Examine group differences in the outcomes assessed in the protocol relative to prior group assignment in the behavioral clinical trials.

OUTLINE:

Participants complete a survey online over 35-45 minutes about their experiences regarding the COVID-19 pandemic.

Eligibility criteria: Inclusion Criteria:

* Prior patients who participated in one of the following protocols: 2012-0112, 2009-0976, or 2005-0035
* Has an active email address or can be contacted via MyChart or personal email

Exclusion Criteria:

* No evidence of consent from prior clinical trials

Primary outcomes:
measure: Coronavirus disease-2019 (COVID19)-specific psychological distress
timeFrame: At baseline
measure: The extent to which COVID-19 experiences are associated with COVID-19 specific psychological distress, health, financial and social disruptions, perceived benefits and social support, and health-related quality of life (HRQoL)
timeFrame: At baseline
measure: Resiliency factors
timeFrame: At baseline
measure: Group differences in the outcomes assessed in the protocol relative to prior group assignment in the behavioral clinical trials
timeFrame: At baseline
measure: Health-related quality of life (HRQOL)
timeFrame: At baseline
measure: General quality of life (QOL)
timeFrame: At baseline
measure: Sleep disturbances
timeFrame: At baseline
measure: Depression
timeFrame: At baseline
measure: Changes in anxiety
timeFrame: At baseline
measure: Perceived availability of social support
timeFrame: At baseline
measure: Elements of mindfulness
timeFrame: At baseline
measure: Non-judgmental physical and emotional sensations associated with eating
timeFrame: At baseline
measure: The degree to which participants exercise compassion towards themselves under difficult circumstances and how this impacts their emotions
timeFrame: At baseline
measure: Physical activity
timeFrame: At baseline
measure: Intrusive thoughts, or the tendency to ruminate on or avoid thoughts about stressors
timeFrame: At baseline
measure: Basic fruit/vegetable intake
timeFrame: At baseline
measure: Usual intake of percentage energy from fat
timeFrame: At baseline
measure: Engagement in the core mind-body practices that the patients learned
timeFrame: At baseline
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: Lorenzo Cohen
role: PRINCIPAL_INVESTIGATOR
References: