Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Perceptions, Experiences, and Activity in CancEr Survivors During COVID-19 (PEACE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04637295
Recruitment Status : Recruiting
First Posted : November 19, 2020
Last Update Posted : January 29, 2021
Sponsor:
Information provided by (Responsible Party):
Diane Ehlers, University of Nebraska

Brief Summary:
To examine perceptions and determinants of physical activity during the COVID-19 pandemic among cancer survivors.

Condition or disease
Neoplasms Malignant

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.

Layout table for study information
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





Primary Outcome Measures :
  1. Physical Activity [ Time Frame: 14 days ]
    Godin Leisure-Time Exercise Questionnaire

  2. Psychosocial Function during COVID-19 [ Time Frame: 14 days ]
    COVID-19 Pandemic Psychosocial Functioning Measure


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. Satisfaction of Life [ Time Frame: 14 days ]
    The Satisfaction of Life Scale (SWLS) is developed to assess global satisfaction is various age groups.

  11. Stress [ Time Frame: 14 days ]
    The Perceived Stress Scale is a 10-item scale developed to measure the perceptions of a person's stress.

  12. 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

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.


Layout table for eligibility information
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
Layout table for location contacts
Contact: Nicholas J Foggia, MS 4025599468 nicholas.foggia@unmc.edu
Contact: Lindsey Page, MS 4025599468 lindsey.hanson@unmc.edu

Locations
Layout table for location information
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
Layout table for investigator information
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).

Layout table for additonal information
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.

Layout table for additional information
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:
Physical Activity
COVID
Cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms