Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2026-01-01 @ 10:48 AM
Study NCT ID:
NCT04637295
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2020-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perceptions, Experiences, and Activity in CancEr Survivors During COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2021-06-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-26', 'studyFirstSubmitDate': '2020-11-17', 'studyFirstSubmitQcDate': '2020-11-18', 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical Activity', 'timeFrame': '14 days', 'description': 'Godin Leisure-Time Exercise Questionnaire'}, {'measure': 'Psychosocial Function during COVID-19', 'timeFrame': '14 days', 'description': 'COVID-19 Pandemic Psychosocial Functioning Measure'}], 'secondaryOutcomes': [{'measure': 'Self-Efficacy', 'timeFrame': '14 days', 'description': 'The Exercise Self-efficacy Scale will be used to measure confidence in ability to exercise. A higher score indicated a higher confidence.'}, {'measure': 'Sleep Quality', 'timeFrame': '14 days', 'description': 'The Pittsburgh Sleep Quality Index will be used to measure sleep quality and disturbances. A higher score indicates a higher sleep disturbance.'}, {'measure': 'Fatigue', 'timeFrame': '14 days', 'description': 'The Functional Assessment in Chronic Illness Therapy - Fatigue (FACIT-F) will be used to measure fatigue as well. Higher scores indicate less fatigue.'}, {'measure': 'Anxiety', 'timeFrame': '14 days', 'description': 'The Hospital Anxiety and Depression Scale (HADS) will be used to produce an anxiety score. Higher scores indicate higher symptoms of anxiety.'}, {'measure': 'Depression', 'timeFrame': '14 days', 'description': 'The Hospital Anxiety and Depression Scale (HADS) will be used to produce an anxiety score. Higher scores indicate higher symptoms of depression.'}, {'measure': 'Loneliness', 'timeFrame': '14 days', 'description': 'The UCLA Loneliness Scale will be used to measure feelings of loneliness and isolation. Higher scores indicate higher degrees of loneliness.'}, {'measure': 'Global Self-Esteem', 'timeFrame': '14 days', 'description': '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.'}, {'measure': 'Subjective Cognitive Impairment', 'timeFrame': '14 days', 'description': '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.'}, {'measure': 'Social Support', 'timeFrame': '14 days', 'description': '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.'}, {'measure': 'Satisfaction of Life', 'timeFrame': '14 days', 'description': 'The Satisfaction of Life Scale (SWLS) is developed to assess global satisfaction is various age groups.'}, {'measure': 'Stress', 'timeFrame': '14 days', 'description': "The Perceived Stress Scale is a 10-item scale developed to measure the perceptions of a person's stress."}, {'measure': 'Perceptions of Exercise', 'timeFrame': 'up to one month after enrollment', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Physical Activity', 'COVID', 'Cancer'], 'conditions': ['Neoplasms Malignant']}, 'referencesModule': {'references': [{'pmid': '4053261', 'type': 'BACKGROUND', '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.'}, {'pmid': '10882320', 'type': 'BACKGROUND', '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.'}, {'pmid': '2748771', 'type': 'BACKGROUND', '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.'}, {'pmid': '1947597', 'type': 'BACKGROUND', '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.'}, {'pmid': '11251013', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '9095563', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12914662', 'type': 'BACKGROUND', '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.'}, {'pmid': '7431205', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '8576833', 'type': 'BACKGROUND', '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.'}, {'type': 'BACKGROUND', '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).'}, {'type': 'BACKGROUND', '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).'}, {'pmid': '11845515', 'type': 'BACKGROUND', '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.'}, {'pmid': '1920028', 'type': 'BACKGROUND', '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.'}, {'pmid': '27095155', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'To examine perceptions and determinants of physical activity during the COVID-19 pandemic among cancer survivors.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Recruiting cancer survivors who have been diagnosed within the last 5 years. Survivors can be at any stage of their cancer diagnosis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult with a history of cancer (except non-invasive skin cancer)\n* Diagnosed at age 19 or older\n* Diagnosed within 5 years of study enrollment\n* Access to a computer, tablet, or smartphone with the Internet\n* English reading\n\nExclusion Criteria:\n\n* Unable to read in English'}, 'identificationModule': {'nctId': 'NCT04637295', 'acronym': 'PEACE', 'briefTitle': 'Perceptions, Experiences, and Activity in CancEr Survivors During COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': 'Perceptions, Experiences, and Activity in CancEr Survivors During COVID-19', 'orgStudyIdInfo': {'id': '0768-20-EX'}}, 'contactsLocationsModule': {'locations': [{'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Diane K Ehlers, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nebraska'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Select data may be shared upon request of the primary investigator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}