COVID-19 Pandemic Induced Stress and Symptoms
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ClinicalTrials.gov Identifier: NCT06036251 |
Recruitment Status :
Completed
First Posted : September 13, 2023
Last Update Posted : September 26, 2023
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Condition or disease | Intervention/treatment |
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Stress Reaction Stress, Emotional Stress COVID-19 Pandemic | Other: Questionnaires |
OBJECTIVES:
- Evaluate for associations among general and disease-specific measures of stress and measures of social isolation and loneliness.
- Evaluate for associations between general and disease-specific stress and common symptoms associated with cancer and its treatments.
- Evaluate for associations between social isolation and loneliness and common symptoms associated with cancer and its treatments.
- 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.
- 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.
Study Type : | Observational |
Actual Enrollment : | 415 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | COVID-19 Pandemic Induced Stress and Symptoms - Follow-up Study |
Actual Study Start Date : | February 1, 2023 |
Actual Primary Completion Date : | April 30, 2023 |
Actual Study Completion Date : | April 30, 2023 |
Group/Cohort | Intervention/treatment |
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Prior oncology participants
Oncology patients at University of California, San Francisco who participated in the previous study which evaluated the additional stressors imposed by COVID-19 (i.e., social isolation, loneliness) and ongoing general and disease specific stress on the symptom burden of cancer patients and survivors.
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Other: Questionnaires
Self-reported quality of life (QOL) measures completed online |
- Correlation of scores on perceived stress scale (PSS) and social isolation scale (SIS) [ Time Frame: 2 days ]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.
- Correlation of scores on the perceived stress scale (PSS) and loneliness scale [ Time Frame: 2 days ]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.
- Correlation of scores on the perceived stress scale (PSS) and symptom severity scores [ Time Frame: 2 days ]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.
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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
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.
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): NCT06036251
United States, California | |
University of California, San Francisco | |
San Francisco, California, United States, 94143 |
Principal Investigator: | Christine Miaskowski, RN,PhD,FAAN | University of California, San Francisco |
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT06036251 |
Other Study ID Numbers: |
23804 NCI-2023-06245 ( Registry Identifier: NCI Clinical Trials Reporting Program (CTRP) ) |
First Posted: | September 13, 2023 Key Record Dates |
Last Update Posted: | September 26, 2023 |
Last Verified: | September 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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