AzTrials
AzTrials

CancerFRAMENCT07281820

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

A study testing FRAME model (questionnaire + dialogue + management plan) in people with Cancer and Late Effects, run by Vejle Hospital at 1 site in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Cancer, Late Effects
What is being tested?
FRAME model (questionnaire + dialogue + management plan)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteDenmark
Study dates
1 Mar 2025to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Johanne D Lyhne, PhD contact

004522910740

JOHANNE.DAM.LYHNE@RSYD.DK

Karin Larsen contact

Karin.Larsen1@rsyd.dk

Denmark1 site, 1 recruiting

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

    Vejle, Region Syddanmark, 7100

    Johanne LYHNE, PhD, +4524453561, JOHANNE.DAM.LYHNE@RSYD.DK

    Karin Larsen, Karin.Larsen1@rsyd.dk

    Recruiting

Other trials in Denmark

About this study

Official 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

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.

Read the 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.

Conditions
Cancer, Late Effects
Being tested
FRAME model (questionnaire + dialogue + management plan)
Keywords
Patient-reported outcomes, Survivorship, Oncology, Implementation science, RE-AIM, Proctor Outcomes, Stepped-care
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FRAME model (questionnaire + dialogue + management plan)Behavioural

    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.

Study groups in NCT07281820
Study groupRoleWhat they receive
Single Arm - Department-wide implementation of FRAMEOtherFRAME model (questionnaire + dialogue + management plan)
Receives: Behavioral: FRAME model (questionnaire + dialogue + management plan)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Adoption

    Measured: 3 months

Secondary outcomes (11)

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

    Reach

    Measured: Continuously during implementation (up to 6 months)

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

    Effectiveness. Target: +15% (exploratory).

    Measured: Up to 6 months

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

    Effectiveness. Target: +10% relative increase (exploratory).

    Measured: Up to 6 months

  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)

    Implementation / fidelity

    Measured: Up to 6 months

  5. Perceived feasibility of active FRAME use among clinicians on a likert-like scale from 1 (not feasible) to 5 (very feasible)

    Feasibility of FRAME (Proctor outcome)

    Measured: 6 months

  6. Clinician-perceived acceptability of FRAME-supported visits on a scale from 1 (not acceptable) to 5 (very acceptable)

    Acceptability (Proctor outcome)

    Measured: 6 months

  7. Perceived fit of FRAME to the oncology outpatient setting and patient population on a scale from 1 (not appropriate) to 5 (very appropriate).

    Appropriateness (Proctor outcome)

    Measured: 6 months

  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).

    Cost

    Measured: 6 months

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

    Penetration

    Measured: 6 months

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

    Maintenance

    Measured: Up to 12 months

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

    Effectiveness

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2025
  2. Study start1 Mar 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07281820
Sponsor's protocol ID
FRAME-PRO
Other IDs
R392-A23403
Acronym
FRAME
Status last verified
Dec 2025
First submitted
14 Nov 2025
Last updated
15 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 40150842

Questions about this trial

What is this clinical trial studying?

A study testing FRAME model (questionnaire + dialogue + management plan) in people with Cancer and Late Effects, run by Vejle Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Johanne D Lyhne, PhD (004522910740, JOHANNE.DAM.LYHNE@RSYD.DK), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of oncologists who actively use FRAME in ≥50% of eligible outpatient visits. (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07281820, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in