Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2026-03-05 @ 6:58 PM
Study NCT ID:
NCT06490393
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Supervision by a Health Care Professional on Quality of Life Questionnaire
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '2 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-04', 'studyFirstSubmitDate': '2024-06-04', 'studyFirstSubmitQcDate': '2024-07-04', 'lastUpdatePostDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EORTC QLQ-C30', 'timeFrame': '2024-2026', 'description': "To study the impact of Health Care Professional supervision on scoring patterns on financially- and sexuality related questions by cancer patients receiving systemic antineoplastic therapy, compared to self-administered electronic completion at home. The null-hypothesis is tested that the method of administration does not influence patients' answers."}, {'measure': 'EORTC QLQ-SH22', 'timeFrame': '2024-2026', 'description': "To study the impact of Health Care Professional supervision on scoring patterns on financially- and sexuality related questions by cancer patients receiving systemic antineoplastic therapy, compared to self-administered electronic completion at home. The null-hypothesis is tested that the method of administration does not influence patients' answers."}, {'measure': 'Questionnaire called "Financial consequences" routinely used by the Social department of St. ClaraSpital', 'timeFrame': '2024-2026', 'description': "To study the impact of Health Care Professional supervision on scoring patterns on financially- and sexuality related questions by cancer patients receiving systemic antineoplastic therapy, compared to self-administered electronic completion at home. The null-hypothesis is tested that the method of administration does not influence patients' answers."}], 'secondaryOutcomes': [{'measure': 'Incidence of reported sexual problems', 'timeFrame': '2024-2026'}, {'measure': 'Patient preference', 'timeFrame': '2024-2026', 'description': 'Reported patient preference of mode of reporting (electronically vs supervised)'}, {'measure': 'Time', 'timeFrame': '2024-2026', 'description': 'Time used by the Health care professional per completion mode'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Health-related Quality of Life']}, 'descriptionModule': {'briefSummary': 'Effect of supervision on scoring and completion on Quality of Life Questionnaire', 'detailedDescription': 'This protocol will study the impact of supervision on completion and scoring of sensitives domains of QoL Questionnaires and QoL Questionnaires in general in a multi-center, randomized, cross-over design in cancer patients receiving systemic antineoplastic therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'It is planned to enroll at least 200 patients into this study. Patient recruitment will be conducted during 2 years (2024-2026)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is ≥18 years of age and legally competent\n* Signed informed consent available\n* Systemic oncologic treatment (e.g. chemotherapy, immunotherapy, endocrine therapy)\n* Current systemic therapy started at least 4 weeks before randomization and is scheduled to continue for at least another 4 weeks after randomization in the same dose and interval\n* Patient is ready and able to complete quality of life questionnaires in German (on paper\n\nExclusion Criteria:\n\n* One or more of the inclusion criteria not met.'}, 'identificationModule': {'nctId': 'NCT06490393', 'acronym': 'IMSUP', 'briefTitle': 'The Impact of Supervision by a Health Care Professional on Quality of Life Questionnaire', 'organization': {'class': 'OTHER', 'fullName': 'St. Claraspital AG'}, 'officialTitle': 'The Impact of Supervision by a Health Care Professional on Quality of Life (QoL) Questionnaire Scoring and Completion:, Randomized, Cross-over Study in Cancer Patients Receiving Systemic Antineoplastic Therapy', 'orgStudyIdInfo': {'id': 'IMSUP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A:paper vs digitally', 'description': 'Arm A: patients in Arm A will receive first an invitation to complete the QoL questionnaires on paper under supervision of an HCP in the hospital before their cycle of systemic antineoplastic therapy starts. Prior to their subsequent cycle of systemic antineoplastic therapy (regardless of duration of cycle), patients in Arm A will be asked to complete the same QoL questionnaires digitally at home.', 'interventionNames': ['Other: Questionnaires']}, {'label': 'B: digitally vs paper', 'description': 'Arm B: patients in Arm B will receive first an invitation to complete the QoL questionnaires digitally at home before their cycle of systemic antineoplastic therapy starts. Prior to their subsequent cycle of systemic antineoplastic therapy (regardless of duration of cycle), patients in Arm B will be asked to complete the same QoL questionnaires on paper under supervision in the hospital.', 'interventionNames': ['Other: Questionnaires']}], 'interventions': [{'name': 'Questionnaires', 'type': 'OTHER', 'description': 'EORTC QLQ-C30 (General Health), EORTC QLQ-SH22(sexual Health), Financial questionnaire as routinely used by the Social Department', 'armGroupLabels': ['A:paper vs digitally', 'B: digitally vs paper']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4058', 'city': 'Basel', 'state': 'Canton of Basel-City', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Diana de Jong-Bakker', 'role': 'CONTACT', 'email': 'diana.bakkerdejong@claraspital.ch', 'phone': '+41616853604'}, {'role': 'CONTACT', 'email': 'diana.bakkerdejong@claraspital.ch', 'phoneExt': 'de Jong-Bakker'}, {'name': 'Diana de Jong-Bakker', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'St Clara Research Ltd', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'centralContacts': [{'name': 'Diana de Jong-Bakker', 'role': 'CONTACT', 'email': 'diana.bakkerdejong@claraspital.ch', 'phone': '+41616853604'}, {'name': 'Arnoud Templeton, PD Dr med', 'role': 'CONTACT', 'email': 'arnoud.templeton@claraspital.ch', 'phone': '+41616858330'}], 'overallOfficials': [{'name': 'Diana de Jong-Bakker', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Claraspital Klinische Forschung'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Claraspital AG', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Diana de Jong', 'investigatorAffiliation': 'St. Claraspital AG'}}}}