NCT07281820

FRAME - Implementation of a PRO Measure to Inform Patient-Centered Survivorship Care in Oncology Outpatient Visits

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Vejle Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer
• Late Effects

Interventions

Type	Name	Description
BEHAVIORAL	FRAME model (questionnaire + dialogue + management plan)	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.

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2025-12-15
• Last updated: 2025-12-15

Locations

1 site across 1 country: Denmark