Quality of Life the Danish Multiple Myeloma Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

681 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-27

Study Completion Date

2023-11-30

Brief Summary

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The aim of the project is to improve quality of life for multiple myeloma patients in the future.

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Detailed Description

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Multiple myeloma is an incurable malignancy of the bone marrow and the second most common type of haematological cancer. In Denmark, about 320 patients are diagnosed annually with multiple myeloma, and the cancer often affects older people, but 30 % of the patients living with MM are of working age. The prognosis has improved markedly over the last two decades and is expected to improve further.

Systematic monitoring of symptoms, side effects and complications over time outside clinical trials has not been performed yet. Knowledge of the elderly and frail patients´ perspective on the multiple myeloma disease is lacking, and the time after anti-myeloma treatment is left unstudied. A common side effect (up to 55 %) to specific types of anti-myeloma drugs is peripheral neuropathy (nerve injury), which can be temporary or permanent in the form of long-term sequelae of pain and numbness. Information on this side effect from the patients´ perspective is missing.

The design of the project is a prospective, population-based, national, longitudinal survey with retrospective data collection from more Danish registers. We will include 800 previously untreated and relapsed multiple myeloma patients at treatment-demanding disease recruited from all Danish haematological departments. At inclusion, demographic data and patient-related prognostic markers will be obtained. The patients will complete four validated QoL instruments (EORTC QLQ-C30, MY20, CIPN20 and SF12v2) at 13 measuring points over a period of 24 months. The questions are concerning cancer and MM symptoms, peripheral neuropathy, other side effects, quality of life and functional capacity of a social, emotional and physical character.

This project will provide real-time data collection of the symptoms, side effects, complications and quality of life from the general multiple myeloma patients´ perspective during and after anti-myeloma treatment. It will illuminate the reason for the patients´ high loss of working ability. The findings will be integrated in the future Danish National treatment guidelines, and recommendation for rehabilitation in aspects of shared decision making.

Conditions

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Quality of Life Multiple Myeloma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Previously untreated or relapsed multiple myeloma patients AND
* Treatment demanding multiple myeloma disease

Exclusion Criteria

* Inability to understand the Danish language or
* Psychic or mental illness that prevents the patient from answering the questions in the questionnaires.

Minimum Eligible Age

18 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No