Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT07281820
Status:
RECRUITING
Last Update Posted:
2025-12-15
First Post:
2025-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
FRAME - Implementation of a PRO Measure to Inform Patient-Centered Survivorship Care in Oncology Outpatient Visits
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2025-12-01', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of oncologists who actively use FRAME in ≥50% of eligible outpatient visits.', 'timeFrame': '3 months', 'description': 'Adoption'}], 'secondaryOutcomes': [{'measure': 'Proportion of eligible outpatient visits with completed FRAME-PRO (via "Mit Sygehus").', 'timeFrame': 'Continuously during implementation (up to 6 months)', 'description': 'Reach'}, {'measure': 'Change in proportion of visits/patients with referrals to supportive care units compared with pre-implementation baseline.', 'timeFrame': 'Up to 6 months', 'description': 'Effectiveness. Target: +15% (exploratory).'}, {'measure': 'Change in patient-reported global quality of life measured on a Likert-like scale from 1 (poor) to 5 (excellent).', 'timeFrame': 'Up to 6 months', 'description': 'Effectiveness. Target: +10% relative increase (exploratory).'}, {'measure': 'Degree to which clinicians and patients (a) open FRAME-PRO during the visit (yes/no), (b) discuss reported needs (yes/no), and (c) manage needs aligned with preferences (yes/no)', 'timeFrame': 'Up to 6 months', 'description': 'Implementation / fidelity'}, {'measure': 'Perceived feasibility of active FRAME use among clinicians on a likert-like scale from 1 (not feasible) to 5 (very feasible)', 'timeFrame': '6 months', 'description': 'Feasibility of FRAME (Proctor outcome)'}, {'measure': 'Clinician-perceived acceptability of FRAME-supported visits on a scale from 1 (not acceptable) to 5 (very acceptable)', 'timeFrame': '6 months', 'description': 'Acceptability (Proctor outcome)'}, {'measure': 'Perceived fit of FRAME to the oncology outpatient setting and patient population on a scale from 1 (not appropriate) to 5 (very appropriate).', 'timeFrame': '6 months', 'description': 'Appropriateness (Proctor outcome)'}, {'measure': 'Time needed to include FRAME-PRO in the visit on a scale from 1 (definitely shorter time with FRAME) to 5 (definitely longer time with FRAME).', 'timeFrame': '6 months', 'description': 'Cost'}, {'measure': 'Integration of FRAME within the outpatient clinic (e.g., percent of clinicians using FRAME routinely)', 'timeFrame': '6 months', 'description': 'Penetration'}, {'measure': 'Sustained active use of FRAME among clinicians in the last 3 months of the study window.', 'timeFrame': 'Up to 12 months', 'description': 'Maintenance'}, {'measure': 'Proportion of patients referred to supportive care units (actual numbers)', 'timeFrame': '6 months', 'description': 'Effectiveness'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Patient-reported outcomes', 'Survivorship', 'Oncology', 'Implementation science', 'RE-AIM', 'Proctor Outcomes', 'Stepped-care'], 'conditions': ['Cancer', 'Late Effects']}, 'referencesModule': {'references': [{'pmid': '40150842', 'type': 'BACKGROUND', 'citation': "Lyhne JD, Gade L, Hansen L, Johansen A, Smith A', Jensen LH, Ventzel L. Survivor-driven development of a PROM for use in routine colorectal cancer care. Acta Oncol. 2025 Mar 27;64:475-483. doi: 10.2340/1651-226X.2025.42032."}]}, 'descriptionModule': {'briefSummary': 'FRAME is a patient-centered survivorship care model embedded in routine oncology visits. It consists of: (1) a pre-visit patient-reported questionnaire (FRAME-PRO), (2) a clinician-patient dialogue guided by the responses, and (3) a tailored management plan including stepped-care referrals (general practitioner and municipality; oncology department supportive services; specialized late-effects clinics). The implementation is evaluated with the RE-AIM framework supplemented by Proctor implementation outcomes. Data sources include the "Mit Sygehus" app, departmental registries, purpose-built questionnaires, fidelity checklists, and qualitative interviews with clinicians, patients, and informal caregivers.', 'detailedDescription': 'The project implements FRAME at the Department of Oncology, Vejle Hospital. The FRAME-PRO enables patients and informal caregivers to reflect on late effects and needs before the visit. During the visit, clinicians access FRAME-PRO electronically to prioritize what matters most, assess severity (triage), and co-create a management plan documented in the electronic health record using a purpose-developed standard phrase to support cross-sector information transfer. Implementation strategies are informed by the Expert Recommendations for Implementing Change (ERIC) and local logs (education, audit \\& feedback, reminders, local champions, technical assistance). Evaluation follows RE-AIM: Reach (completion of FRAME-PRO), Effectiveness (referrals to supportive care, quality of life, time use), Adoption (clinician use), Implementation (fidelity to opening, discussing, and managing needs), and Maintenance (sustained use). Quantitative data are summarized descriptively; qualitative data are analyzed with content analysis. Ethics approval covers interviews with patients, caregivers, and clinicians.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- All oncologists conducting outpatient visits at the Department of Oncology, Vejle Hospital during the study period.\n\nExclusion Criteria:\n\n\\- None.\n\nParticipants for interviews:\n\n* A purposive sample of patients, informal caregivers, and clinicians approached ≥6 months after launch\n* written and verbally informed consent.'}, 'identificationModule': {'nctId': 'NCT07281820', 'acronym': 'FRAME', 'briefTitle': 'FRAME - Implementation of a PRO Measure to Inform Patient-Centered Survivorship Care in Oncology Outpatient Visits', 'organization': {'class': 'OTHER', 'fullName': 'Vejle Hospital'}, 'officialTitle': 'FRAME (Focused Recognition, Assessment and Management of Late Effects): A Single-Center Implementation Study Using RE-AIM to Guide Evaluation in the Department of Oncology, Vejle Hospital', 'orgStudyIdInfo': {'id': 'FRAME-PRO'}, 'secondaryIdInfos': [{'id': 'R392-A23403', 'type': 'OTHER_GRANT', 'domain': 'Danish Cancer Society'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Single Arm - Department-wide implementation of FRAME', 'description': 'FRAME model (questionnaire + dialogue + management plan)', 'interventionNames': ['Behavioral: FRAME model (questionnaire + dialogue + management plan)']}], 'interventions': [{'name': 'FRAME model (questionnaire + dialogue + management plan)', 'type': 'BEHAVIORAL', 'description': 'Administration of the patient-developed FRAME-PRO prior to the visit; clinician-patient dialogue guided by responses; stepped-care management/referrals; documentation via standard EHR phrase. Implementation strategies include educational meetings/materials, ongoing training, audit \\& feedback at weekly huddles, reminders/prompts, local champions, and local technical assistance.', 'armGroupLabels': ['Single Arm - Department-wide implementation of FRAME']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7100', 'city': 'Vejle', 'state': 'Region Syddanmark', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Johanne LYHNE, PhD', 'role': 'CONTACT', 'email': 'JOHANNE.DAM.LYHNE@RSYD.DK', 'phone': '+4524453561'}, {'name': 'Karin Larsen', 'role': 'CONTACT', 'email': 'Karin.Larsen1@rsyd.dk'}, {'name': 'Johanne D LYHNE, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Oncology, Vejle Hospital, University Hospital of Southern Denmark', 'geoPoint': {'lat': 55.70927, 'lon': 9.5357}}], 'centralContacts': [{'name': 'Johanne D Lyhne, PhD', 'role': 'CONTACT', 'email': 'JOHANNE.DAM.LYHNE@RSYD.DK', 'phone': '004522910740'}, {'name': 'Karin Larsen', 'role': 'CONTACT', 'email': 'Karin.Larsen1@rsyd.dk'}], 'overallOfficials': [{'name': 'Torben F Hansen, Dr. Med.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Oncology, Vejle Hospital, University Hospital of Southern Denmark, Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vejle Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}