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Trial record 26 of 1281 for:    physician patient AND (relations OR communication) | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT03163433
Recruitment Status : Recruiting
First Posted : May 23, 2017
Last Update Posted : October 27, 2017
Sponsor:
Collaborators:
Danish Cancer Society
AmbuFlex
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Melanoma Quality of Life Behavioral: Feedback in the consultation Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 282 participants
Allocation: Non-Randomized
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
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : November 2019

Arm Intervention/treatment
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
Usual consultations



Primary Outcome Measures :
  1. Patient Activation Measure (PAM) [ Time Frame: 1 year ]
    A 13-item measurement of patients' knowledge, skills, and confidence for managing their health and healthcare


Secondary Outcome Measures :
  1. Functional Assessment of Cancer Therapy - Melanoma (FACT-M) [ Time Frame: 1 year ]
    A 51-item measurement of quality of life

  2. Cancer Behavior Inventory (CBI) [ Time Frame: 1 year ]
    A 14-item measurement of self-efficacy in patients with cancer

  3. Perceived Efficacy in Patient-Physician Interaction (PEPPI) [ Time Frame: 1 year ]
    A 5-item measurement of patient-physician interaction



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

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


Contacts
Contact: Pernille Skovlund, MScN +45 61309177 pernille.skovlund@oncology.au.dk

Locations
Denmark
Aarhus University Hospital, Department of Oncology Recruiting
Aarhus, Denmark, 8000
Contact: Pernille Skovlund, PhD student    0045 6130 9177    pernille.skovlund@oncology.au.dk   
Contact: Lene Skovlund    0045 7846 2620    skovlund@oncology.au.dk   
Sponsors and Collaborators
University of Aarhus
Danish Cancer Society
AmbuFlex
Investigators
Study Chair: Kirsten Lomborg, Professor University of Aarhus

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03163433     History of Changes
Other Study ID Numbers: Feedback in the consultation
First Posted: May 23, 2017    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Aarhus:
Patient activation measure
Self-efficacy
Patient participation in research
Patient reported outcome measures