FRAME - Implementation of a PRO Measure to Inform Patient-Centered Survivorship Care in Oncology Outpatient Visits
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorVejle Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
A purposive sample of patients, informal caregivers, and clinicians approached ≥6 months after launch
written and verbally informed consent.
Trial design
Design model
Single group
Treatments tested in this trial
FRAME model (questionnaire + dialogue + management plan)
BehavioralAdministration 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Single Arm - Department-wide implementation of FRAMEOther 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of oncologists who actively use FRAME in ≥50% of eligible outpatient visits.
Adoption
Time frame
3 monthsSecondary outcomes
1
Proportion of eligible outpatient visits with completed FRAME-PRO (via "Mit Sygehus").
Reach
Time frame
Continuously during implementation (up to 6 months)2
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 months3
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 months4
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov