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

Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

COVID-19: Well-Being and HRQOL in Cancer Patients Who Participated in Prior Behavioral Clinical Trials

ClinicalTrials.gov ID

NCT04447222

Acronym / sponsor ID

2020-0425

Conditions

COVID-19 Infection, Malignant Solid Neoplasm

Study type

Observational

Recruitment status

Active, not recruiting

Enrolment

1,242 participants (estimated)

Lead sponsor

M.D. Anderson Cancer CenterUniversity, hospital or other

Collaborators

National Cancer Institute (NCI)

Study start

12 May 2020 (actual)

Primary completion

30 Jul 2028 (estimated)

Study completion

30 Jul 2028 (estimated)

First posted

25 Jun 2020 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Cross-sectional

Number of arms

1

Who may qualify

Sex

All

Healthy volunteers

Accepted

Age groups

Child, Adult, Older adult

Study population

Patients with cancer who have participated in prior behavioral clinical trials.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

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."

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
• MD Anderson Cancer Center WebsiteLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

1 site in 1 country: see every site and its status.