NCT03163433

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
282

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 23, 2017

Completed
20 days until next milestone

Study Start

First participant enrolled

June 12, 2017

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

January 25, 2021

Status Verified

January 1, 2021

Enrollment Period

3.6 years

First QC Date

May 8, 2017

Last Update Submit

January 22, 2021

Conditions

MelanomaQuality of Life

Keywords

Patient activation measureSelf-efficacyPatient participation in researchPatient reported outcome measures

Outcome Measures

Primary Outcomes (1)

  • Patient Activation Measure (PAM)

    A 13-item measurement of patients' knowledge, skills, and confidence for managing their health and healthcare

    1 year

Secondary Outcomes (3)

  • Functional Assessment of Cancer Therapy - Melanoma (FACT-M)

    1 year

  • Cancer Behavior Inventory (CBI)

    1 year

  • Perceived Efficacy in Patient-Physician Interaction (PEPPI)

    1 year

Study Arms (2)

Feedback in the consultation

EXPERIMENTAL

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

Control

NO INTERVENTION

Usual consultations

Interventions

Feedback in the consultationBEHAVIORAL

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.

Feedback in the consultation

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital, Department of Oncology

Aarhus, 8000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 32699648DERIVED

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Kirsten Lomborg, Professor

    University of Aarhus

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The intervention takes place at a highly specialized university hospital i Denmark. Two other higly specialized Danish hospitals recruit patients for the control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2017

First Posted

May 23, 2017

Study Start

June 12, 2017

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

January 25, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)