- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04637295
Perceptions, Experiences, and Activity in CancEr Survivors During COVID-19 (PEACE)
September 26, 2023 updated by: University of Nebraska
To examine perceptions and determinants of physical activity during the COVID-19 pandemic among cancer survivors.
Study Overview
Status
Completed
Conditions
Detailed Description
This purpose of this study is to examine perceptions and determinants of physical activity during the COVID-19 pandemic in cancer survivors.
To test our aim, we will recruit up to 1000 adults diagnosed with cancer within the last five years and ask them to complete an online questionnaire battery assessing their self-reported physical activity habits, psychosocial outcomes (e.g., depression, anxiety, self-efficacy, social support), and perceptions of physical activity engagement during the pandemic.
A subsample of participants (n=50) will also be invited to participate in an interview to gain further insights into cancer survivors' physical activity experiences during COVID-19.
Analysis of covariance (ANCOVA) will be used to analyze the quantitative survey data, and thematic analysis will be used to analyze the qualitative interview data.
Study Type
Observational
Enrollment (Actual)
18
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Nebraska
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Omaha, Nebraska, United States, 68198
- University of Nebraska Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Recruiting cancer survivors who have been diagnosed within the last 5 years.
Survivors can be at any stage of their cancer diagnosis.
Description
Inclusion Criteria:
- Adult with a history of cancer (except non-invasive skin cancer)
- Diagnosed at age 19 or older
- Diagnosed within 5 years of study enrollment
- Access to a computer, tablet, or smartphone with the Internet
- English reading
Exclusion Criteria:
- Unable to read in English
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical Activity
Time Frame: 14 days
|
Godin Leisure-Time Exercise Questionnaire
|
14 days
|
|
Psychosocial Function during COVID-19
Time Frame: 14 days
|
COVID-19 Pandemic Psychosocial Functioning Measure
|
14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-Efficacy
Time Frame: 14 days
|
The Exercise Self-efficacy Scale will be used to measure confidence in ability to exercise.
A higher score indicated a higher confidence.
|
14 days
|
|
Sleep Quality
Time Frame: 14 days
|
The Pittsburgh Sleep Quality Index will be used to measure sleep quality and disturbances.
A higher score indicates a higher sleep disturbance.
|
14 days
|
|
Fatigue
Time Frame: 14 days
|
The Functional Assessment in Chronic Illness Therapy - Fatigue (FACIT-F) will be used to measure fatigue as well.
Higher scores indicate less fatigue.
|
14 days
|
|
Anxiety
Time Frame: 14 days
|
The Hospital Anxiety and Depression Scale (HADS) will be used to produce an anxiety score.
Higher scores indicate higher symptoms of anxiety.
|
14 days
|
|
Depression
Time Frame: 14 days
|
The Hospital Anxiety and Depression Scale (HADS) will be used to produce an anxiety score.
Higher scores indicate higher symptoms of depression.
|
14 days
|
|
Loneliness
Time Frame: 14 days
|
The UCLA Loneliness Scale will be used to measure feelings of loneliness and isolation.
Higher scores indicate higher degrees of loneliness.
|
14 days
|
|
Global Self-Esteem
Time Frame: 14 days
|
The Rosenberg Self-Esteem Scale (RSE) will be used to measure global self-esteem.
Items are used to calculate an esteem score, higher scores are indicative of higher esteem.
|
14 days
|
|
Subjective Cognitive Impairment
Time Frame: 14 days
|
The Functional Assessment in Cancer Therapy- Cognition (FACT-Cog) measures levels of cognitive impairment, quality of life and perceived cognitive ability.
Items are summed up to calculate scores from each subsection.
|
14 days
|
|
Social Support
Time Frame: 14 days
|
The Social Support of Exercise scale is aimed to assess the degree in which family and friends demonstrate support for exercise behavior.
Higher scores indicate a higher level of support.
|
14 days
|
|
Satisfaction of Life
Time Frame: 14 days
|
The Satisfaction of Life Scale (SWLS) is developed to assess global satisfaction is various age groups.
|
14 days
|
|
Stress
Time Frame: 14 days
|
The Perceived Stress Scale is a 10-item scale developed to measure the perceptions of a person's stress.
|
14 days
|
|
Perceptions of Exercise
Time Frame: up to one month after enrollment
|
A qualitative interview will be performed to measure the perceptions and barriers of exercise during the COVID-19 pandemic.
This interview is comprised of items designed by the research team.
|
up to one month after enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Diane K Ehlers, PhD, University of Nebraska
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
- Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.
- Russell DW. UCLA Loneliness Scale (Version 3): reliability, validity, and factor structure. J Pers Assess. 1996 Feb;66(1):20-40. doi: 10.1207/s15327752jpa6601_2.
- Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E. Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. J Pain Symptom Manage. 1997 Feb;13(2):63-74. doi: 10.1016/s0885-3924(96)00274-6.
- Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. doi: 10.1186/1477-7525-1-29.
- Basen-Engquist K, Bodurka-Bevers D, Fitzgerald MA, Webster K, Cella D, Hu S, Gershenson DM. Reliability and validity of the functional assessment of cancer therapy-ovarian. J Clin Oncol. 2001 Mar 15;19(6):1809-17. doi: 10.1200/JCO.2001.19.6.1809.
- Russell D, Peplau LA, Cutrona CE. The revised UCLA Loneliness Scale: concurrent and discriminant validity evidence. J Pers Soc Psychol. 1980 Sep;39(3):472-80. doi: 10.1037//0022-3514.39.3.472.
- Buysse DJ, Reynolds CF 3rd, Monk TH, Hoch CC, Yeager AL, Kupfer DJ. Quantification of subjective sleep quality in healthy elderly men and women using the Pittsburgh Sleep Quality Index (PSQI). Sleep. 1991 Aug;14(4):331-8. Erratum In: Sleep 1992 Feb;15(1):83.
- Resnick B, Jenkins LS. Testing the reliability and validity of the Self-Efficacy for Exercise scale. Nurs Res. 2000 May-Jun;49(3):154-9. doi: 10.1097/00006199-200005000-00007.
- Robins, R. W., Hendin, H. M. & Trzesniewski, K. H. Measuring global self-esteem: Construct validation of a single-item measure and the Rosenberg Self-Esteem Scale. Personal. Soc. Psychol. Bull. 27, 151-161 (2001).
- Wagner, L. I., Sweet, J., Butt, Z., Lai, J. & Cella, D. Measuring patient self-report cognitive function: Development of the functional assessment of cancer therapy-cognitive function instrument. J. Support. Oncol. 7, W32-W39 (2009).
- Resnick B, Orwig D, Magaziner J, Wynne C. The effect of social support on exercise behavior in older adults. Clin Nurs Res. 2002 Feb;11(1):52-70. doi: 10.1177/105477380201100105.
- Pavot W, Diener E, Colvin CR, Sandvik E. Further validation of the Satisfaction with Life Scale: evidence for the cross-method convergence of well-being measures. J Pers Assess. 1991 Aug;57(1):149-61. doi: 10.1207/s15327752jpa5701_17.
- Nielsen MG, Ornbol E, Vestergaard M, Bech P, Larsen FB, Lasgaard M, Christensen KS. The construct validity of the Perceived Stress Scale. J Psychosom Res. 2016 May;84:22-30. doi: 10.1016/j.jpsychores.2016.03.009. Epub 2016 Mar 16.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 27, 2021
Primary Completion (Actual)
June 17, 2021
Study Completion (Actual)
June 17, 2021
Study Registration Dates
First Submitted
November 17, 2020
First Submitted That Met QC Criteria
November 18, 2020
First Posted (Actual)
November 19, 2020
Study Record Updates
Last Update Posted (Actual)
September 28, 2023
Last Update Submitted That Met QC Criteria
September 26, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0768-20-EX
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Select data may be shared upon request of the primary investigator.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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