Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-25 @ 4:08 AM
NCT ID:
NCT07281820
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT07281820
Study Brief:
Protocol Section:
NCT07281820