Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2026-02-20 @ 5:56 PM
Study NCT ID:
NCT03654950
Status:
COMPLETED
Last Update Posted:
2022-11-07
First Post:
2018-08-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Empowerment With the Patient Perspective
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-04', 'studyFirstSubmitDate': '2018-08-30', 'studyFirstSubmitQcDate': '2018-08-30', 'lastUpdatePostDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient reported experiences in themes', 'timeFrame': '1 day', 'description': 'interview'}], 'secondaryOutcomes': [{'measure': 'Patient reported experiences divided into themes', 'timeFrame': '12 months', 'description': 'Interview'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'The overall aim with this study is to gain a deeper understanding of patient perceptions regarding empowerment in relation to a health platform.', 'detailedDescription': 'This is a two-stage study design. The first stage consists of focus groups interviews. Three focus groups with 6-8 patients (colorectal cancer patients diagnosed at least one year ago) in each group, will be invited. The focus group interviews will be moderated by one researcher, but accompanied with a second observing researcher. The participants will be identified using the regional Swedish ColoRectal Cancer Registry in Västra Götaland. The participants will be contacted by a short letter (appendix) indicating that we will call them with more information. The participants will by phone be asked to participate in the study and then invited to the focus groups.\n\nThe second phase of the project includes a questionnaire, which will be sent to 200 patients from the same population. The questionnaires will be delivered by using the Sunet Survey system, which is a system approved by University of Gothenburg. If the participants prefers a paper copy, or lack the possibility to reply online, a paper copy will be send via mail instead.\n\nAt this moment the investigators have developed a questionnaire, which may be refined due to the understating achieved from the focus group interviews.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with colorectal cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with colorectal cancer\n\nExclusion Criteria:\n\n* Inability to give informed consent or speaking and reading the Swedish language.'}, 'identificationModule': {'nctId': 'NCT03654950', 'acronym': 'PEPP', 'briefTitle': 'Patient Empowerment With the Patient Perspective', 'organization': {'class': 'OTHER', 'fullName': 'Sahlgrenska University Hospital'}, 'officialTitle': 'PEPP - Patient Empowerment With the Patient Perspective', 'orgStudyIdInfo': {'id': 'PEPP'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'Interviews and questionnaires'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE 416 85', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Dept. of Surgery, Sahlgrenska University Hospital/Ostra', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'overallOfficials': [{'name': 'Eva Angenete', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sahlgrenska University Hospital and University of Gothenburg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Högskolan Väst', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor, consultant surgeon', 'investigatorFullName': 'Eva Angenete', 'investigatorAffiliation': 'Sahlgrenska University Hospital'}}}}