Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2026-06-14 @ 6:59 AM
Study NCT ID:
NCT02042469
Status:
COMPLETED
Last Update Posted:
2014-01-22
First Post:
2014-01-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Awareness and Attitude of Cancer Patients About Participation in Clinical Research (CR) in Saudi Arabia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-19', 'studyFirstSubmitDate': '2014-01-15', 'studyFirstSubmitQcDate': '2014-01-19', 'lastUpdatePostDateStruct': {'date': '2014-01-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure the awareness and attitudes', 'timeFrame': '2 years', 'description': 'To study the Awareness and Attitudes of Saudi adult cancer patients towards participation in clinical research.'}], 'secondaryOutcomes': [{'measure': 'assess knowledge', 'timeFrame': '2 years', 'description': 'To assess the knowledge of cancer patients about the clinical research process. To assess cancer patients willingness to participate in clinical research. To identify the patients barriers to clinical research participation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['awareness, clinical research, Saudi arabia'], 'conditions': ['Oncology [See Also, Affected System]']}, 'descriptionModule': {'briefSummary': 'Enrollment of patients in CR may be impacted by their levels of awareness and attitude toward participation. Our study aims at assessing the awareness and willingness to participate in CR and identifying the barriers and influencing factors for participation.\n\nA cross-sectional study was performed using an interview-based questionnaire composed of close-ended questions conducted by trained research coordinators. Descriptive statistics, univariate and multivariate analyses were applied.', 'detailedDescription': "Clinical Trials are essential for the identification of effective therapies in modern medicine. As the biomedical understanding of diseases increases, a growing number of new opportunities will require increasing numbers of patients agreeing to participate in a clinical trial\n\nPublic awareness about the need for clinical research and the benefit beyond participation is important. Although the main objective of clinical trials is to provide a high standard of care and help in advancement of medical knowledge, only a small portion of patients receive treatment as part of a formal clinical trial\n\nMisconceptions about clinical trials are frequent, primarily due to lack of adequate information from the treating physician; the complexity of the study procedure; preferences of patients regarding a particular treatment or no treatment; uncertainty and the experimental nature of a clinical trial (additional side effects, less known about the treatment) and concern about confidential information are some of the significant barriers to participation. Healthy individuals and patients do not have the same perception, since patients have stressed and vulnerable feelings after diagnosis of their illness having a negative impact on patient's attitude towards a trial.\n\nThe ability to recruit patients for future clinical trials will depend, in part, on understanding the barriers of participation in clinical trials. Unfortunately, there is no data about the public awareness and attitudes toward participation in clinical trials in Kingdom of Saudi Arabia. It is the purpose of this study to address this issue to create some baseline data to increase the accrual rate of clinical trials."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study is planned to take place among Oncology patients ( inpatient and outpatient).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdult patient (18 years and above) with cancer diagnosis. Adult patients who are treated services at King Abdulaziz Medical City (KAMC), National Guard Health Affairs(NGHA) Riyadh Willing to complete the survey questionnaire\n\nExclusion Criteria:\n\nPatients who refuse to complete the survey questionnaire'}, 'identificationModule': {'nctId': 'NCT02042469', 'briefTitle': 'Awareness and Attitude of Cancer Patients About Participation in Clinical Research (CR) in Saudi Arabia', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Guard Health Affairs'}, 'orgStudyIdInfo': {'id': 'Awareness'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Survey', 'description': 'Cross-sectional survey will be carried out using an interview questionnaire composed of close-ended questions to be completed by trained research coordinator.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'King Abdul Aziz Medical City for National Guard', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}], 'overallOfficials': [{'name': 'Nagham RZ Sheblaq, CCRP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'King Abdul Aziz Medical City for National Guard'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Guard Health Affairs', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}