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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 : Completed
First Posted : May 23, 2017
Last Update Posted : January 25, 2021
Sponsor:
Collaborators:
Danish Cancer Society
AmbuFlex
Information provided by (Responsible Party):
University of Aarhus

Tracking Information
First Submitted Date  ICMJE May 8, 2017
First Posted Date  ICMJE May 23, 2017
Last Update Posted Date January 25, 2021
Actual Study Start Date  ICMJE June 12, 2017
Actual Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2017)
Patient Activation Measure (PAM) [ Time Frame: 1 year ]
A 13-item measurement of patients' knowledge, skills, and confidence for managing their health and healthcare
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feedback in the Consultation - a Dialogue-based Tool in Personalised Care Planning Using Systematic Patient Involvement
Official Title  ICMJE Feedback in the Consultation - a Dialogue-based Tool in Personalised Care Planning Using Systematic Patient Involvement
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Melanoma
  • Quality of Life
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Feedback in the consultation
  • No Intervention: Control
    Usual consultations
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 22, 2017)
282
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 1, 2021
Actual Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03163433
Other Study ID Numbers  ICMJE Feedback in the consultation
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Aarhus
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE
  • Danish Cancer Society
  • AmbuFlex
Investigators  ICMJE
Study Chair: Kirsten Lomborg, Professor University of Aarhus
PRS Account University of Aarhus
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP