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

Vejle Hospital

Status: Enrolling

Conditions: Late Effects; Cancer

Treatments: Behavioral: FRAME model (questionnaire + dialogue + management plan)

Study type: Interventional

Funder types: Other

Identifiers

NCT07281820

FRAME-PRO

R392-A23403 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Single Arm - Department-wide implementation of FRAME

Other group

Description:

FRAME model (questionnaire + dialogue + management plan)

Treatment:

Behavioral: FRAME model (questionnaire + dialogue + management plan)