Clinical trial NCT06036251: COVID-19 Pandemic Induced Stress and Symptoms
Official title: COVID-19 Pandemic Induced Stress and Symptoms - Follow-up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress Reaction
Stress, Emotional
Stress
COVID-19 Pandemic
Keywords: Follow-up Study
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 415
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Only previous patients and survivors who took part in our last COVID survey in 2020-2021 who agreed to be re-contacted for future research at University of California, San Francisco

Brief summary: The previous survey of oncology patients at University of California, San Francisco in 2020-2021 found an alarmingly high symptom burden and high levels of stress and loneliness among respondents. This is a follow-up study with the same sample of oncology patients and survivors who participated in the previous study

Detailed description: OBJECTIVES:

1. Evaluate for associations among general and disease-specific measures of stress and measures of social isolation and loneliness.
2. Evaluate for associations between general and disease-specific stress and common symptoms associated with cancer and its treatments.
3. Evaluate for associations between social isolation and loneliness and common symptoms associated with cancer and its treatments.
4. Evaluate for associations between social isolation and loneliness and health behaviors and quality of life (QOL) as compared to our last survey. as a baseline.
5. Evaluate for changes in stress, social isolation, loneliness and symptom burden between the two time points.

OUTLINE:

Patients will be asked to complete self-report questionnaires online. Questionnaires will take approximately 60 minutes to complete. and directed to take rest periods at 20 minute intervals. Participants will be given two weeks to complete the instruments.

Eligibility criteria: Inclusion Criteria:

* Current/Previous diagnosis of cancer
* Able to read, write, and understand English
* Able to complete the study questionnaires on line
* Able consent to participate.

Exclusion Criteria:

* Participants of our previous COVID survey study who opted out of future research.

Primary outcomes:
measure: Correlation of scores on perceived stress scale (PSS) and social isolation scale (SIS)
timeFrame: 2 days
measure: Correlation of scores on the perceived stress scale (PSS) and loneliness scale
timeFrame: 2 days
measure: Correlation of scores on the perceived stress scale (PSS) and symptom severity scores
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Christine Miaskowski, RN,PhD,FAAN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miaskowski C, Paul SM, Snowberg K, Abbott M, Borno HT, Chang SM, Chen LM, Cohen B, Cooper BA, Hammer MJ, Kenfield SA, Kober KM, Laffan A, Levine JD, Pozzar R, Rhoads K, Tsai KK, Van Blarigan EL, Van Loon K. Loneliness and symptom burden in oncology patients during the COVID-19 pandemic. Cancer. 2021 Sep 1;127(17):3246-3253. doi: 10.1002/cncr.33603. Epub 2021 Apr 27.
citation: Miaskowski C, Paul SM, Snowberg K, Abbott M, Borno H, Chang S, Chen LM, Cohen B, Hammer MJ, Kenfield SA, Kober KM, Levine JD, Pozzar R, Rhoads KF, Van Blarigan EL, Van Loon K. Stress and Symptom Burden in Oncology Patients During the COVID-19 Pandemic. J Pain Symptom Manage. 2020 Nov;60(5):e25-e34. doi: 10.1016/j.jpainsymman.2020.08.037. Epub 2020 Sep 2.
citation: Miaskowski C, Paul SM, Snowberg K, Abbott M, Borno H, Chang S, Chen LM, Cohen B, Cooper BA, Hammer MJ, Kenfield SA, Laffan A, Levine JD, Pozzar R, Tsai KK, Van Blarigan EL, Van Loon K. Oncology patients' perceptions of and experiences with COVID-19. Support Care Cancer. 2021 Apr;29(4):1941-1950. doi: 10.1007/s00520-020-05684-7. Epub 2020 Aug 18.