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

Neoplasms Malignant Clinical Trial

— PEACE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04637295
• Other study ID #: 0768-20-EX
• Status: Completed
• Start date: January 27, 2021
• Est. completion date: June 17, 2021

Study information

• Verified date: September 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 17, 2021
• Est. primary completion date: June 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Neoplasms Malignant

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

References & Publications (14)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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).

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. — View Citation

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. — View Citation

Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. doi: 10.1186/1477-7525-1-29. — View Citation

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).

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Activity	Godin Leisure-Time Exercise Questionnaire	14 days
Primary	Psychosocial Function during COVID-19	COVID-19 Pandemic Psychosocial Functioning Measure	14 days
Secondary	Self-Efficacy	The Exercise Self-efficacy Scale will be used to measure confidence in ability to exercise. A higher score indicated a higher confidence.	14 days
Secondary	Sleep Quality	The Pittsburgh Sleep Quality Index will be used to measure sleep quality and disturbances. A higher score indicates a higher sleep disturbance.	14 days
Secondary	Fatigue	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
Secondary	Anxiety	The Hospital Anxiety and Depression Scale (HADS) will be used to produce an anxiety score. Higher scores indicate higher symptoms of anxiety.	14 days
Secondary	Depression	The Hospital Anxiety and Depression Scale (HADS) will be used to produce an anxiety score. Higher scores indicate higher symptoms of depression.	14 days
Secondary	Loneliness	The UCLA Loneliness Scale will be used to measure feelings of loneliness and isolation. Higher scores indicate higher degrees of loneliness.	14 days
Secondary	Global Self-Esteem	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
Secondary	Subjective Cognitive Impairment	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
Secondary	Social Support	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
Secondary	Satisfaction of Life	The Satisfaction of Life Scale (SWLS) is developed to assess global satisfaction is various age groups.	14 days
Secondary	Stress	The Perceived Stress Scale is a 10-item scale developed to measure the perceptions of a person's stress.	14 days
Secondary	Perceptions of Exercise	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