Clinical trial NCT03163433: Feedback in the Consultation - a Dialogue-based Tool in Personalised Care Planning Using Systematic Patient Involvement
Official title: Feedback in the Consultation - a Dialogue-based Tool in Personalised Care Planning Using Systematic Patient Involvement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melanoma
Quality of Life
Keywords: Patient activation measure
Self-efficacy
Patient participation in research
Patient reported outcome measures
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
name: AmbuFlex
First posted: 2017-05-23
Enrollment: 282
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention takes place at a highly specialized university hospital i Denmark. Two other higly specialized Danish hospitals recruit patients for the control group.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Patients receiving treatment for metastatic melanoma in Denmark
* Manage to read and speak Danish

Exclusion Criteria:

-

Primary outcomes:
measure: Patient Activation Measure (PAM)
timeFrame: 1 year
Secondary outcomes:
measure: Functional Assessment of Cancer Therapy - Melanoma (FACT-M)
timeFrame: 1 year
measure: Cancer Behavior Inventory (CBI)
timeFrame: 1 year
measure: Perceived Efficacy in Patient-Physician Interaction (PEPPI)
timeFrame: 1 year
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Department of Oncology
Study officials:
affiliation: University of Aarhus
name: Kirsten Lomborg, Professor
role: STUDY_CHAIR
References:
citation: Skovlund PC, Nielsen BK, Thaysen HV, Schmidt H, Finset A, Hansen KA, Lomborg K. The impact of patient involvement in research: a case study of the planning, conduct and dissemination of a clinical, controlled trial. Res Involv Engagem. 2020 Jul 19;6:43. doi: 10.1186/s40900-020-00214-5. eCollection 2020.