Perceptions, Experiences, and Activity in CancEr Survivors During COVID-19 (PEACE)
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| ClinicalTrials.gov Identifier: NCT04637295 |
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Recruitment Status :
Recruiting
First Posted : November 19, 2020
Last Update Posted : January 29, 2021
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Sponsor:
University of Nebraska
Information provided by (Responsible Party):
Diane Ehlers, University of Nebraska
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Brief Summary:
To examine perceptions and determinants of physical activity during the COVID-19 pandemic among cancer survivors.
| Condition or disease |
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| Neoplasms Malignant |
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 |
| Estimated Enrollment : | 1000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Cross-Sectional |
| Official Title: | Perceptions, Experiences, and Activity in CancEr Survivors During COVID-19 |
| Actual Study Start Date : | January 27, 2021 |
| Estimated Primary Completion Date : | June 30, 2021 |
| Estimated Study Completion Date : | June 30, 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Cancer--Living with Cancer
Primary Outcome Measures :
- Physical Activity [ Time Frame: 14 days ]Godin Leisure-Time Exercise Questionnaire
- Psychosocial Function during COVID-19 [ Time Frame: 14 days ]COVID-19 Pandemic Psychosocial Functioning Measure
Secondary Outcome Measures :
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Satisfaction of Life [ Time Frame: 14 days ]The Satisfaction of Life Scale (SWLS) is developed to assess global satisfaction is various age groups.
- Stress [ Time Frame: 14 days ]The Perceived Stress Scale is a 10-item scale developed to measure the perceptions of a person's stress.
- 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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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.
Criteria
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
Information from the National Library of Medicine
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): NCT04637295
Contacts
| Contact: Nicholas J Foggia, MS | 4025599468 | nicholas.foggia@unmc.edu | |
| Contact: Lindsey Page, MS | 4025599468 | lindsey.hanson@unmc.edu |
Locations
| United States, Nebraska | |
| University of Nebraska Medical Center | Recruiting |
| Omaha, Nebraska, United States, 68198-8440 | |
| Contact: Nicholas Foggia nicholas.foggia@unmc.edu | |
Sponsors and Collaborators
University of Nebraska
Investigators
| Principal Investigator: | Diane K Ehlers, PhD | University of Nebraska |
Publications:
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).
| Responsible Party: | Diane Ehlers, Assistant Professor, University of Nebraska |
| ClinicalTrials.gov Identifier: | NCT04637295 |
| Other Study ID Numbers: |
768-20 |
| First Posted: | November 19, 2020 Key Record Dates |
| Last Update Posted: | January 29, 2021 |
| Last Verified: | January 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Plan Description: | Select data may be shared upon request of the primary investigator. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Diane Ehlers, University of Nebraska:
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Physical Activity COVID Cancer |
Additional relevant MeSH terms:
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Neoplasms |