COVID-19 Pandemic Induced Stress and Symptoms

Sponsor
University of California, San Francisco (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06036251
Collaborator
(none)
1,200
1
60
20

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaires

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
1200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
COVID-19 Pandemic Induced Stress and Symptoms - Follow-up Study
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2028
Anticipated Study Completion Date :
Nov 1, 2028

Arms and Interventions

Arm Intervention/Treatment
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.

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

Outcome Measures

Primary Outcome Measures

  1. Correlation of scores on perceived stress scale (PSS) and social isolation scale (SIS) [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.

  2. Correlation of scores on the perceived stress scale (PSS) and loneliness scale [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.

  3. Correlation of scores on the perceived stress scale (PSS) and symptom severity scores [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California, San Francisco San Francisco California United States 94143

Sponsors and Collaborators

  • University of California, San Francisco

Investigators

  • Principal Investigator: Christine Miaskowski, RN,PhD,FAAN, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT06036251
Other Study ID Numbers:
  • 23804
  • NCI-2023-06245
First Posted:
Sep 13, 2023
Last Update Posted:
Sep 13, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of California, San Francisco
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 13, 2023