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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07281820
Acronym
FRAME
Enrollment
30
Registered
2025-12-15
Start date
2025-03-01
Completion date
2027-12-31
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Late Effects

Keywords

Patient-reported outcomes, Survivorship, Oncology, Implementation science, RE-AIM, Proctor Outcomes, Stepped-care

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.

Interventions

BEHAVIORALFRAME 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.

Sponsors

Vejle Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Proportion of oncologists who actively use FRAME in ≥50% of eligible outpatient visits.3 monthsAdoption

Secondary

MeasureTime frameDescription
Change in proportion of visits/patients with referrals to supportive care units compared with pre-implementation baseline.Up to 6 monthsEffectiveness. Target: +15% (exploratory).
Change in patient-reported global quality of life measured on a Likert-like scale from 1 (poor) to 5 (excellent).Up to 6 monthsEffectiveness. Target: +10% relative increase (exploratory).
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)Up to 6 monthsImplementation / fidelity
Perceived feasibility of active FRAME use among clinicians on a likert-like scale from 1 (not feasible) to 5 (very feasible)6 monthsFeasibility of FRAME (Proctor outcome)
Clinician-perceived acceptability of FRAME-supported visits on a scale from 1 (not acceptable) to 5 (very acceptable)6 monthsAcceptability (Proctor outcome)
Proportion of eligible outpatient visits with completed FRAME-PRO (via Mit Sygehus).Continuously during implementation (up to 6 months)Reach
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).6 monthsCost
Integration of FRAME within the outpatient clinic (e.g., percent of clinicians using FRAME routinely)6 monthsPenetration
Sustained active use of FRAME among clinicians in the last 3 months of the study window.Up to 12 monthsMaintenance
Proportion of patients referred to supportive care units (actual numbers)6 monthsEffectiveness
Perceived fit of FRAME to the oncology outpatient setting and patient population on a scale from 1 (not appropriate) to 5 (very appropriate).6 monthsAppropriateness (Proctor outcome)

Countries

Denmark

Contacts

Primary ContactJohanne D Lyhne, PhD
JOHANNE.DAM.LYHNE@RSYD.DK004522910740
Backup ContactKarin Larsen
Karin.Larsen1@rsyd.dk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026