Feedback in the Consultation - a Dialogue-based Tool in Personalised Care Planning Using Systematic Patient Involvement
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03163433|
Recruitment Status : Completed
First Posted : May 23, 2017
Last Update Posted : January 25, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma Quality of Life||Behavioral: Feedback in the consultation||Not Applicable|
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.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||282 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Feedback in the Consultation - a Dialogue-based Tool in Personalised Care Planning Using Systematic Patient Involvement|
|Actual Study Start Date :||June 12, 2017|
|Actual Primary Completion Date :||January 1, 2021|
|Actual Study Completion Date :||January 1, 2021|
Experimental: 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.
Behavioral: Feedback in the consultation
Patients will complete electronic Patient Reported Outcome Measures (PROM) before the consultation at the hospital. The results are fed back to physicians. In the consultation patients will systematically participate in a dialogue with their physician about issues that are most important for the patients.
No Intervention: Control
- Patient Activation Measure (PAM) [ Time Frame: 1 year ]A 13-item measurement of patients' knowledge, skills, and confidence for managing their health and healthcare
- Functional Assessment of Cancer Therapy - Melanoma (FACT-M) [ Time Frame: 1 year ]A 51-item measurement of quality of life
- Cancer Behavior Inventory (CBI) [ Time Frame: 1 year ]A 14-item measurement of self-efficacy in patients with cancer
- Perceived Efficacy in Patient-Physician Interaction (PEPPI) [ Time Frame: 1 year ]A 5-item measurement of patient-physician interaction
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03163433
|Aarhus University Hospital, Department of Oncology|
|Aarhus, Denmark, 8000|
|Study Chair:||Kirsten Lomborg, Professor||University of Aarhus|