Feedback in the Consultation - a Dialogue-based Tool in Personalised Care Planning Using Systematic Patient Involvement

Not Applicable

Completed

• Conditions: Melanoma; Quality of Life
• Interventions: Behavioral: Feedback in the consultation

• Registration Number: NCT03163433
• Lead Sponsor: University of Aarhus

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.

Study Timeline

• Study First Submitted: 2017-05-08
• Study First Submitted QC: 2017-05-22
• Study First Posted: 2017-05-23
• Study Start: 2017-06-12
• Status Verified: 2021-01
• Primary Completion: 2021-01-01
• Study Completion: 2021-01-01
• Last Update Submitted: 2021-01-22
• Last Update Posted: 2021-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 282

Inclusion Criteria

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

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Feedback in the consultation	Feedback in the consultation	Feedback in the consultation is the intervention. Patients complete PROM before each consultation and take part in a dialogue about the results with their physician.

Primary Outcome Measures

Name	Time	Method
Patient Activation Measure (PAM)	1 year	A 13-item measurement of patients' knowledge, skills, and confidence for managing their health and healthcare

Secondary Outcome Measures

Name	Time	Method
Functional Assessment of Cancer Therapy - Melanoma (FACT-M)	1 year	A 51-item measurement of quality of life
Cancer Behavior Inventory (CBI)	1 year	A 14-item measurement of self-efficacy in patients with cancer
Perceived Efficacy in Patient-Physician Interaction (PEPPI)	1 year	A 5-item measurement of patient-physician interaction

Trial Locations

Locations (1)

Aarhus University Hospital, Department of Oncology; 🇩🇰 Aarhus, Denmark