FRAME - Implementation of a PRO Measure to Inform Patient-Centered Survivorship Care in Oncology Outpatient Visits
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FRAME model (questionnaire + dialogue + management plan).
- Who it may be relevant to
- Registry conditions: Cancer, Late Effects. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
- 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.
Primary outcome measures
- Proportion of oncologists who actively use FRAME in ≥50% of eligible outpatient visits. [Time frame: 3 months]
Secondary outcome measures (11)
- Proportion of eligible outpatient visits with completed FRAME-PRO (via "Mit Sygehus"). [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. [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). [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) [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) [Time frame: 6 months]
- Clinician-perceived acceptability of FRAME-supported visits on a scale from 1 (not acceptable) to 5 (very acceptable) [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). [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). [Time frame: 6 months]
- Integration of FRAME within the outpatient clinic (e.g., percent of clinicians using FRAME routinely) [Time frame: 6 months]
- Sustained active use of FRAME among clinicians in the last 3 months of the study window. [Time frame: Up to 12 months]
- Proportion of patients referred to supportive care units (actual numbers) [Time frame: 6 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Denmark · 1 center
- Department of Oncology, Vejle Hospital, University Hospital of Southern Denmark — Vejle
Publications
- Lyhne 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
Identifiers
NCT: NCT07281820 · FRAME-PRO · R392-A23403