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

December 1, 2025 updated by: Vejle Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
    • Region Syddanmark
      • Vejle, Region Syddanmark, Denmark, 7100
        • Recruiting
        • Department of Oncology, Vejle Hospital, University Hospital of Southern Denmark
        • Contact:
        • Contact:
        • Principal Investigator:
          • Johanne D LYHNE, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single Arm - Department-wide implementation of FRAME
FRAME model (questionnaire + dialogue + management plan)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of oncologists who actively use FRAME in ≥50% of eligible outpatient visits.
Time Frame: 3 months
Adoption
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of eligible outpatient visits with completed FRAME-PRO (via "Mit Sygehus").
Time Frame: Continuously during implementation (up to 6 months)
Reach
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
Effectiveness. Target: +15% (exploratory).
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
Effectiveness. Target: +10% relative increase (exploratory).
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
Implementation / fidelity
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
Feasibility of FRAME (Proctor outcome)
6 months
Clinician-perceived acceptability of FRAME-supported visits on a scale from 1 (not acceptable) to 5 (very acceptable)
Time Frame: 6 months
Acceptability (Proctor outcome)
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
Appropriateness (Proctor outcome)
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
Cost
6 months
Integration of FRAME within the outpatient clinic (e.g., percent of clinicians using FRAME routinely)
Time Frame: 6 months
Penetration
6 months
Sustained active use of FRAME among clinicians in the last 3 months of the study window.
Time Frame: Up to 12 months
Maintenance
Up to 12 months
Proportion of patients referred to supportive care units (actual numbers)
Time Frame: 6 months
Effectiveness
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vejle Hospital

Investigators

  • Study Director: Torben F Hansen, Dr. Med., Department of Oncology, Vejle Hospital, University Hospital of Southern Denmark, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

December 1, 2025

First Posted (Actual)

December 15, 2025

Study Record Updates

Last Update Posted (Actual)

December 15, 2025

Last Update Submitted That Met QC Criteria

December 1, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FRAME-PRO
  • R392-A23403 (Other Grant/Funding Number: Danish Cancer Society)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cancer

Clinical Trials on FRAME model (questionnaire + dialogue + management plan)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe