Survivor-driven development of a PROM for use in routine colorectal cancer care.
Johanne D Lyhne, Lise Gade, Laila Hansen...
https://pubmed.ncbi.nlm.nih.gov/40150842Actively Recruiting
Led by Vejle Hospital · Updated on 2025-12-15
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
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
FRAME - Implementation of a PRO Measure to Inform Patient-Centered Survivorship Care in Oncology Outpatient Visits
You may qualify if you...
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
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Total: 1 location
1
Department of Oncology, Vejle Hospital, University Hospital of Southern Denmark
Vejle, Region Syddanmark, Denmark, 7100
Actively Recruiting
J
Johanne D Lyhne, PhD
K
Karin Larsen
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
1
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Johanne D Lyhne, Lise Gade, Laila Hansen...
https://pubmed.ncbi.nlm.nih.gov/40150842