Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03163433 |
| Other study ID # |
Feedback in the consultation |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 12, 2017 |
| Est. completion date |
January 1, 2021 |
Study information
| Verified date |
January 2021 |
| Source |
University of Aarhus |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The aim of the study is to examine the potentials of involving patients with metastatic
melanoma in their own care planning through systematic use of patient-reported outcome
measures (PROM). Furthermore, to examine the outcome of health-related quality of life,
self-efficacy and impact on the patient-physician interaction.
Patients (N=282) will be included from three highly specialized hospitals in Denmark. At one
hospital patients will complete PROM before each consultation during a year (intervention
group). At the two other hospitals patients will not complete PROM (control group). In
addition to baseline, measurements will take place after three, six and 12 months. The
project is organized and executed with patient involvement in the research process.
Description:
Background:
In recent years, treatment of metastatic melanoma has changed significantly, which has led to
improved prognosis and greater expectations for the future. However, new concerns in relation
to health-related quality of life and coping with disease in everyday life have emerged.
Patient-reported outcome measures (PROM) is a promising tool to strengthen patient
involvement. By systematically reporting real time PROM to the physician prior to a
consultation, it may generate a continuous feedback loop, by which the patient physician
dialogue can focus on what is most important to the patient.
Hypothesis:
The aim of the study is to investigate the potentials of using PROM as a dialogue-based tool.
We hypothesize that PROM as a dialogue-based tool can:
- Improve patients' knowledge, skills, and confidence for managing their health and
healthcare
- Reduce the perceived burden of physical symptoms and emotional dysfunction
- Improve the quality of the patient-physician interaction
Material and methods:
In this prospective study patients (N=282) will be included from three highly specialized
hospitals in Denmark. At Aarhus University Hospital, patients will complete electronic PROM
before the consultation and systematically participate in a dialogue about their
self-assessments for a duration of one year (intervention group). At Herlev Hospital and
Odense University Hospital, patients will not complete PROM (control group). In addition to
baseline, self-reported measurements will take place after three, six and 12 months.
To address the patient perspective, patients with melanoma are involved in the project
management. A steering group with scientists and patient representatives has been
established. This group have chosen the relevant PROM, determined primary objectives and
given feedback on the written information material for the intervention by looking at
relevance and readability. Moreover the group will ensure optimal implementation if results
are promising. In addition, a patient focus group will be established to discuss how PROM
should be used in the consultation and how patient involvement is expressed in practice. The
recruitment of patients to these groups will be made in cooperation with the association for
patients with melanoma and clinical practice where the patients are treated.
Perspectives If results are positive, the intervention will be easy to apply to routine
settings and in a slightly adjusted form in other groups of cancer patients too.
