Actively Recruiting

Phase Not Applicable
All Genders
ID07281820

FRAME Implementation Using RE-AIM to Evaluate Patient-Centered Survivorship Care in Oncology Outpatient Visits at Vejle Hospital

Led by Vejle Hospital · Updated on 2025-12-15

30

Participants Needed

1

Research Sites

52 weeks

Total Duration

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AI-Summary

What this Trial Is About

This research evaluates the FRAME model, a patient-centered approach designed to improve survivorship care for cancer patients experiencing late effects. The study is conducted at the Department of Oncology, Vejle Hospital, and aims to assess how well FRAME can be integrated into routine outpatient oncology visits. The project uses the RE-AIM framework along with Proctor implementation outcomes to understand the implementation process and effects on patient care. The FRAME model includes three key components: a patient-reported questionnaire completed before the visit (FRAME-PRO), a clinician-patient conversation guided by the questionnaire responses, and a customized management plan that may include referrals to general practitioners, municipal services, oncology supportive care, or specialized late-effect clinics. Implementation strategies involve educational meetings, ongoing training, audit and feedback sessions, reminders, local champions, and technical assistance to support uptake. Participants include oncologists at the hospital who will use FRAME during outpatient visits. Data collection involves electronic completion of FRAME-PRO via the "Mit Sygehus" app, clinical documentation in electronic health records, and various questionnaires and interviews with patients, caregivers, and clinicians. Researchers will measure how frequently oncologists use FRAME, patient quality of life, referrals to supportive care, and clinician perceptions of feasibility and acceptability. The study follows participants and clinicians for up to one year to evaluate sustained use and impact.

CONDITIONS

Brief Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • All oncologists conducting outpatient visits at the Department of Oncology, Vejle Hospital during the study period.
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - Up to 6 months

Participants complete the FRAME-PRO questionnaire before their oncology outpatient visit. During the visit, clinicians use the FRAME-PRO responses to guide discussion and develop a personalized management plan documented in the electronic health record. Implementation includes education, training, audit and feedback, reminders, and technical support to support use of the FRAME model.

Outpatient visits as scheduled during the 6-month implementation period

Long-term Monitoring

Duration - Up to 12 months

Clinicians’ sustained use of the FRAME model and patient outcomes are monitored for up to 12 months to evaluate ongoing adoption and integration within routine care.

Ongoing observation during routine outpatient visits

Trial Site Locations

Total: 1 location

1

Department of Oncology, Vejle Hospital, University Hospital of Southern Denmark

Vejle, Region Syddanmark, Denmark, 7100

Actively Recruiting

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Research Team

J

Johanne D Lyhne, PhD

K

Karin Larsen

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

1

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