An interventional study of FRAME model (questionnaire + dialogue + management plan) in Cancer and Late Effects, sponsored by Vejle Hospital. Recruiting at 1 site in Denmark. Per ClinicalTrials.gov, last updated 2025-12-15.
Sponsored by Vejle Hospital · Not applicable, Interventional, and Health services research
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.
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 30 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Vejle Hospital is the lead sponsor of 93 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
- All oncologists conducting outpatient visits at the Department of Oncology, Vejle Hospital during the study period.
Exclusion Criteria:
- None.
Participants for interviews:
FRAME model (questionnaire + dialogue + management plan)
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.
Proportion of oncologists who actively use FRAME in ≥50% of eligible outpatient visits.
Adoption
Time frame: 3 months
Proportion of eligible outpatient visits with completed FRAME-PRO (via "Mit Sygehus").
Reach
Time frame: Continuously during implementation (up to 6 months)
Change in proportion of visits/patients with referrals to supportive care units compared with pre-implementation baseline.
Effectiveness. Target: +15% (exploratory).
Time frame: Up to 6 months
Change in patient-reported global quality of life measured on a Likert-like scale from 1 (poor) to 5 (excellent).
Effectiveness. Target: +10% relative increase (exploratory).
Time frame: Up to 6 months
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)
Implementation / fidelity
Time frame: Up to 6 months
Perceived feasibility of active FRAME use among clinicians on a likert-like scale from 1 (not feasible) to 5 (very feasible)
Feasibility of FRAME (Proctor outcome)
Time frame: 6 months
Clinician-perceived acceptability of FRAME-supported visits on a scale from 1 (not acceptable) to 5 (very acceptable)
Acceptability (Proctor outcome)
Time frame: 6 months
Perceived fit of FRAME to the oncology outpatient setting and patient population on a scale from 1 (not appropriate) to 5 (very appropriate).
Appropriateness (Proctor outcome)
Time frame: 6 months
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).
Cost
Time frame: 6 months
Integration of FRAME within the outpatient clinic (e.g., percent of clinicians using FRAME routinely)
Penetration
Time frame: 6 months
Sustained active use of FRAME among clinicians in the last 3 months of the study window.
Maintenance
Time frame: Up to 12 months
Proportion of patients referred to supportive care units (actual numbers)
Effectiveness
Time frame: 6 months
Plan to share: Undecided
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Vejle Hospital