NCT07281820

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable cancer

Timeline
21mo left

Started Mar 2025

Typical duration for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Mar 2025Dec 2027

Study Start

First participant enrolled

March 1, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 15, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

December 15, 2025

Status Verified

December 1, 2025

Enrollment Period

1.8 years

First QC Date

November 14, 2025

Last Update Submit

December 1, 2025

Conditions

CancerLate Effects

Keywords

Patient-reported outcomesSurvivorshipOncologyImplementation scienceRE-AIMProctor OutcomesStepped-care

Outcome Measures

Primary Outcomes (1)

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

    Adoption

    3 months

Secondary Outcomes (11)

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

    Continuously during implementation (up to 6 months)

  • Change in proportion of visits/patients with referrals to supportive care units compared with pre-implementation baseline.

    Up to 6 months

  • Change in patient-reported global quality of life measured on a Likert-like scale from 1 (poor) to 5 (excellent).

    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)

    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)

    6 months

  • +6 more secondary outcomes

Study Arms (1)

Single Arm - Department-wide implementation of FRAME

OTHER

FRAME model (questionnaire + dialogue + management plan)

Behavioral: FRAME model (questionnaire + dialogue + management plan)

Interventions

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.

Single Arm - Department-wide implementation of FRAME

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- All oncologists conducting outpatient visits at the Department of Oncology, Vejle Hospital during the study period.

You may not qualify if:

  • \- None.
  • Participants for interviews:
  • A purposive sample of patients, informal caregivers, and clinicians approached ≥6 months after launch
  • written and verbally informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Vejle, Region Syddanmark, 7100, Denmark

RECRUITING

Related Publications (1)

  • Lyhne JD, Gade L, Hansen L, Johansen A, Smith A', Jensen LH, Ventzel L. Survivor-driven development of a PROM for use in routine colorectal cancer care. Acta Oncol. 2025 Mar 27;64:475-483. doi: 10.2340/1651-226X.2025.42032.

    PMID: 40150842BACKGROUND

MeSH Terms

Conditions

Neoplasms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Torben F Hansen, Dr. Med.

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

    STUDY DIRECTOR

Central Study Contacts

Johanne D Lyhne, PhD

CONTACT

004522910740JOHANNE.DAM.LYHNE@RSYD.DK

Karin Larsen

CONTACT

Karin.Larsen1@rsyd.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2025

First Posted

December 15, 2025

Study Start

March 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

December 15, 2025

Record last verified: 2025-12

Locations

DK(1)