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NCT Number: NCT07281820

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

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.

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Key information

Conditions

Cancer Late Effects Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Vejle, Region Syddanmark, 7100, Denmark

Location status: Recruiting

Location contact

Johanne D LYHNE, PhD

PRINCIPAL_INVESTIGATOR

Johanne LYHNE, PhD

CONTACT

[email protected]

+4524453561

Karin Larsen

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FRAME model (questionnaire + dialogue + management plan)

Behavioral

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 outcomes

  1. Proportion of oncologists who actively use FRAME in ≥50% of eligible outpatient visits.

    Time frame: 3 months

    Adoption

Secondary outcomes

  1. Proportion of eligible outpatient visits with completed FRAME-PRO (via "Mit Sygehus").

    Time frame: Continuously during implementation (up to 6 months)

    Reach

  2. 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).

  3. 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).

  4. 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

  5. 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. 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)

  7. 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)

  8. 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

  9. Integration of FRAME within the outpatient clinic (e.g., percent of clinicians using FRAME routinely)

    Time frame: 6 months

    Penetration

  10. Sustained active use of FRAME among clinicians in the last 3 months of the study window.

    Time frame: Up to 12 months

    Maintenance

  11. Proportion of patients referred to supportive care units (actual numbers)

    Time frame: 6 months

    Effectiveness

Study contacts

Contact information is provided by the study sponsor or research team.

Johanne D Lyhne, PhD

CONTACT

[email protected]

004522910740

Karin Larsen

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Vejle Hospital

Other

Registry information

Official study 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

Acronym: FRAME

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 15, 2025
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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