- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04447222
Impact of the COVID-19 Pandemic and HRQOL in Cancer Patients and Survivors
COVID-19: Well-Being and HRQOL in Cancer Patients Who Participated in Prior Behavioral Clinical Trials
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Lorenzo Cohen
- Phone Number: 713-745-4260
- Email: lcohen@mdanderson.org
Study Locations
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Texas
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Houston, Texas, United States, 77030
- M D Anderson Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Observational (survey)
Participants complete a survey online over 35-45 minutes about their experiences regarding the COVID-19 pandemic.
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Ancillary studies
Other Names:
Ancillary studies
Complete survey
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Coronavirus disease-2019 (COVID19)-specific psychological distress
Time Frame: At baseline
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Assessed using a COVID-19 questionnaire.
Responses are provided on a Likert scale (from 1 to 4) where participants are asked to rank statements from "strongly disagree" to "strongly agree.''
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At baseline
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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)
Time Frame: At baseline
|
Will be tested using path analysis.
Path analyses also provides an opportunity to test direct and indirect or mediation effects.
Significance and goodness of fit of the model will be interpreted using several indices.
A Comparative Fit Index (CFI) value of 0.90 or greater and a Root Mean Square Error of Approximation (RMSEA) of 0.08 or less will be used to establish model fit.
The Lagrange multiplier and the Wald tests will be used to guide model modifications.
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At baseline
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Resiliency factors
Time Frame: At baseline
|
Assessed using a COVID-19 questionnaire.
Responses are provided on a Likert scale (from 1 to 4) where participants are asked to rank statements from "strongly disagree" to "strongly agree."
The measure provides a total score summary that indicates the degree to which the COVID-19 pandemic has negatively impacted the participant.
Items that tap into resiliency are reverse scored.
Will use multigroup analyses by levels of the moderator to identify differences in the magnitude of the associations based on the level of the moderator.
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At baseline
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Group differences in the outcomes assessed in the protocol relative to prior group assignment in the behavioral clinical trials
Time Frame: At baseline
|
Will be assessed using appropriate analysis of covariance (ANCOVA) techniques adjusting for important confounders differentiating those who did and did not complete the current survey.
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At baseline
|
Health-related quality of life (HRQOL)
Time Frame: At baseline
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Assessed using the Functional Assessment of Cancer Therapy-7 (FACTG7).
The FACTG7 is a well-validated and commonly used measure of HRQoL in oncology.
A total score provides an index of HRQoL, with higher scores reflecting better HRQOL
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At baseline
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General quality of life (QOL)
Time Frame: At baseline
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Will be assessed using the Medical Outcomes Study 36-item short-form survey (SF-36).
The FACTG7 is a well-validated and commonly used measure of HRQoL in oncology.
A total score provides an index of HRQoL, with higher scores reflecting better HRQOL
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At baseline
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Sleep disturbances
Time Frame: At baseline
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Will be assessed using the Pittsburgh Sleep Quality Index (PSQI).
The PSQI is an 18-item self-rated questionnaire that assesses quality of sleep and sleep disturbances over a 1-month period.
The PSQI has good internal and test-retest reliability.
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At baseline
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Depression
Time Frame: At baseline
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Will be assessed using the Centers for Epidemiological Studies-Depression measures (CES-D).
The CES-D is a well-validated 20-item self-report measure of depression that focuses on affective components of depression.
Internal consistency is high and it also has demonstrated adequate convergent validity with other measures of depression.
Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
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At baseline
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Changes in anxiety
Time Frame: At baseline
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Will be assessed using the Speilberger State/Trait Anxiety Inventory (STAI).
The STATE scale (Form Y-1) is a 20-item scale that provides information about a person's current level of anxiety.
The TRAIT scale (Form Y-2) is a 20-item scale that provides information about a person's general anxiety.
STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80)
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At baseline
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Perceived availability of social support
Time Frame: At baseline
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Will be measured using the 24-item Social Provisions Scale that includes subscales for attachment, social integration, opportunity for nurturance, reassurance of worth, reliable alliance, and guidance.
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At baseline
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Elements of mindfulness
Time Frame: At baseline
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Will be assessed using the Five Facets of Mindfulness Questionnaire.
This assessment provides statements relating to the five components observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience and asks participants to mark the extent to which each statement is true in their life, using a five-point scale.
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At baseline
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Non-judgmental physical and emotional sensations associated with eating
Time Frame: At baseline
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Will be assessed using the Mindful Eating Questionnaire validated by Framson et al. at each time point.
Scoring of this evaluation provides an overall "summary" score, as well individual scores in the five categories of awareness, distraction, dis-inhibition, emotions, and external factors while eating.
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At baseline
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The degree to which participants exercise compassion towards themselves under difficult circumstances and how this impacts their emotions
Time Frame: At baseline
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Will be assessed using the Self-Compassion Scale.
This assessment is a 12-item questionnaire that provides questions about self-judgments, self-kindness, common humanity, isolation, mindfulness and over-identification using a five-point scale.
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At baseline
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Physical activity
Time Frame: At baseline
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Will be assessed with the Godin Leisure-Time Exercise Questionnaire.
This questionnaire has been used extensively in research with cancer survivors.
It is easy to administer. the activity score of 24 units and more as active (substantial benefits); the activity score of 14-23 units as moderately active (some benefits); and the activity score of 13 units and less as inactive (less substantial or low benefits) at first.
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At baseline
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Intrusive thoughts, or the tendency to ruminate on or avoid thoughts about stressors
Time Frame: At baseline
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Will be measured using the Impact of Event Scale (IES) that assesses the two most common categories of responses to stressful events: intrusion (intrusively experienced ideas, images, feelings, or bad dreams) and avoidance (consciously recognized avoidance of certain ideas, feelings, or situations).
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At baseline
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Basic fruit/vegetable intake
Time Frame: At baseline
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Will monitor patients' diets using The National Institutes of Health - Fruit and Vegetable Screener.
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At baseline
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Usual intake of percentage energy from fat
Time Frame: At baseline
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Will be assessed using The National Institutes of Health - Fat Screener.
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At baseline
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Engagement in the core mind-body practices that the patients learned
Time Frame: At baseline
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As engagement in mind-body practices has been found to decrease stress, engagement in the core Mind-body practices that the patients learned in the past will be assessed with an instrument that lists the different techniques and mind body practices and ask study participants how often they have practiced each technique.
The scale goes from "not at all to more than once a day".
The instrument also asks participants about the benefits obtained from practicing each technique, the scale goes from "does not apply/I did not practice to yes, definitively beneficial."
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At baseline
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lorenzo Cohen, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-0425 (Other Identifier: M D Anderson Cancer Center)
- NCI-2020-03900 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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