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Impact of the COVID-19 Pandemic and HRQOL in Cancer Patients and Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04447222
Recruitment Status : Recruiting
First Posted : June 25, 2020
Last Update Posted : June 25, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment
COVID-19 Infection Malignant Solid Neoplasm Other: Quality-of-Life Assessment Other: Questionnaire Administration Other: Survey Administration

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.

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Study Type : Observational
Estimated Enrollment : 1242 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: COVID-19: Well-Being and HRQOL in Cancer Patients Who Participated in Prior Behavioral Clinical Trials
Actual Study Start Date : May 12, 2020
Estimated Primary Completion Date : July 21, 2021
Estimated Study Completion Date : July 21, 2021

Group/Cohort Intervention/treatment
Observational (survey)
Participants complete a survey online over 35-45 minutes about their experiences regarding the COVID-19 pandemic.
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Other: Survey Administration
Complete survey




Primary Outcome Measures :
  1. Coronavirus disease-2019 (COVID19)-specific psychological distress [ 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.''

  2. 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.

  3. 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.

  4. 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.

  5. Health-related quality of life (HRQOL) [ Time Frame: At baseline ]
    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

  6. General quality of life (QOL) [ Time Frame: At baseline ]
    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

  7. Sleep disturbances [ Time Frame: At baseline ]
    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.

  8. Depression [ Time Frame: At baseline ]
    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.

  9. Changes in anxiety [ Time Frame: At baseline ]
    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)

  10. Perceived availability of social support [ Time Frame: At baseline ]
    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.

  11. Elements of mindfulness [ Time Frame: At baseline ]
    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.

  12. Non-judgmental physical and emotional sensations associated with eating [ Time Frame: At baseline ]
    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.

  13. The degree to which participants exercise compassion towards themselves under difficult circumstances and how this impacts their emotions [ Time Frame: At baseline ]
    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.

  14. Physical activity [ Time Frame: At baseline ]
    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.

  15. Intrusive thoughts, or the tendency to ruminate on or avoid thoughts about stressors [ Time Frame: At baseline ]
    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).

  16. Basic fruit/vegetable intake [ Time Frame: At baseline ]
    Will monitor patients' diets using The National Institutes of Health - Fruit and Vegetable Screener.

  17. Usual intake of percentage energy from fat [ Time Frame: At baseline ]
    Will be assessed using The National Institutes of Health - Fat Screener.

  18. Engagement in the core mind-body practices that the patients learned [ Time Frame: At baseline ]
    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."



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with cancer who have participated in prior behavioral clinical trials.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04447222


Contacts
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Contact: Lorenzo Cohen 713-745-4260 lcohen@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Lorenzo Cohen       lcohen@mdanderson.org   
Principal Investigator: Lorenzo Cohen         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Lorenzo Cohen M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04447222    
Other Study ID Numbers: 2020-0425
NCI-2020-03900 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2020-0425 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: June 25, 2020    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No