Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Late Effects | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FRAME model (questionnaire + dialogue + management plan) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- 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)
Primary outcomes (1)
- measure
- Proportion of oncologists who actively use FRAME in ≥50% of eligible outpatient visits.
- timeFrame
- 3 months
- description
- Adoption
Secondary outcomes (11)
- measure
- Proportion of eligible outpatient visits with completed FRAME-PRO (via "Mit Sygehus").
- timeFrame
- Continuously during implementation (up to 6 months)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: \- All oncologists conducting outpatient visits at the Department of Oncology, Vejle Hospital during the study period. Exclusion Criteria: \- None. Participants for interviews: * A purposive sample of patients, informal caregivers, and clinicians approached ≥6 months after launch * written and verbally informed consent.
References
Publications (1)
- BACKGROUNDLyhne 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. PMID 40150842