COVID-19 Pandemic Induced Stress and Symptoms

Stress Clinical Trial

Official title:

COVID-19 Pandemic Induced Stress and Symptoms - Follow-up Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06036251
• Other study ID #: 23804
• Secondary ID: NCI-2023-06245
• Status: Completed
• Start date: February 1, 2023
• Est. completion date: April 30, 2023

Study information

• Verified date: September 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 415
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pandemic
• Fractures, Stress
• Stress
• Stress Reaction
• Stress, Emotional

Intervention

Other:
• Questionnaires
Self-reported quality of life (QOL) measures completed online

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of scores on perceived stress scale (PSS) and social isolation scale (SIS)	Scores on the Perceived Stress Scale (PSS) from the previous study and this study, along with scores on the Social Isolation Scale (SIS) from the previous study, this study will be compared. The PSS is a 10-item questionnaire which asks participants about feelings and thoughts during the last month. Scores of each item ranging from 0 = "Never" to 4 = "Very Often" for a total score range of 0 to 40. Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to 4 of the 10 positively stated items and scores are calculated by summing the total. Higher scores indicate higher degree of perceived stress. The Social Isolation Scale (SIS) is a measure used to assess an individual's tendency to isolate themselves from social situations. Scores on this scale are distributed with a mean of 15.0 and a standard deviation of 4.5.	2 days
Primary	Correlation of scores on the perceived stress scale (PSS) and loneliness scale	Scores on the Perceived Stress Scale (PSS) from the previous study and this study, along with scores on the University of California, Los Angeles (UCLA) Loneliness Scale from the previous study, and this study will be compared. The PSS is a 10-item questionnaire which asks participants about feelings and thoughts during the last month. Scores of each item ranging from 0 = "Never" to 4 = "Very Often" for a total score range of 0 to 40. Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to 4 of the 10 positively stated items and scores are calculated by summing the total. Higher scores indicate higher degree of perceived stress. The 3-item UCLA loneliness scale is a 3-item scale used for measuring loneliness with scores ranging from 1='Hardly ever" to 3=Often. Scores are summed to generate a total score with higher scores indicating a higher degree of loneliness.	2 days
Primary	Correlation of scores on the perceived stress scale (PSS) and symptom severity scores	Scores on the PSS from the previous study and this study, along with scores on Memorial Symptom Assessment Scale (MSAS) from the previous study, and this study will be compared. The PSS is a 10-item questionnaire which asks participants about feelings and thoughts during the last month. Scores of each item ranging from 0 = "Never" to 4 = "Very Often" for a total score range of 0 to 40. Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to 4 of the 10 positively stated items and scores are calculated by summing the total. Higher scores indicate higher degree of perceived stress. The MSAS is used to assess common physical symptoms experienced by persons with cancer. The values for severity and frequency measurements are 1='slight' or 'rarely' and 4= 'very severe'/'almost constantly' .Higher values indicate a greater number of symptoms.	2 days