Multidisciplinary Follow-up of Patients Treated for Malignant Hematological Disease

• Conditions: Malignant Hematologic Neoplasm

• Registration Number: NCT03031106
• Lead Sponsor: Aalborg University Hospital

Brief Summary

The aim of this study is to adjust and test an existing internet-based tool for collecting patient-reported outcome measures and to use the internet-based tool in an multidisciplinary follow-up of patients treated for malignant hematological diseases. The patient-reported outcome measurements will be used in describing the patients' health-related quality of life (HRQoL) and to investigate whether the HRQol will increase due to participation in multidisciplinary follow-up.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-01-12
• Study First Submitted QC: 2017-01-23
• Study First Posted: 2017-01-25
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-01
• Last Update Posted: 2018-03-02
• Primary Completion: 2018-07
• Study Completion: 2019-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• patients diagnosed with malignant hematological disease; Morbus Hodgkin and B- and T-cell disease
• patients followed before or after 1. line treatment
• patients in stable phase > 6 months after 1. line treatment
• the patients participation in the study must be assessed and decided by the doctor responsible for the patient's course of treatment

Exclusion Criteria

• Health conditions which demands close medical monitoring
• conditions which compromise the ability to understand the study and submit informed consent (ex.: dementia and severe mental illness / disability)
• lack of capability to fill out electronic questionnaires
• poor self-care and/or compliance

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Health-Related Quality of Life (HRQoL) - General	HRQoL is assessed every 2, 3, 4 or 6 months, up to 18 months.	Patients will be asked to electronically fill out questionnaires before each consultation.; The questionnaire that will be used to measure HRQoL is SF-36. SF-36 is a generic questionnaire which can be used to assess HRQoL in the general public.
Health-Related Quality of Life (HRQoL) - Disease specific	HRQoL is assessed every 2, 3, 4 or 6 months, up to 18 months.	Patients will be asked to electronically fill out questionnaires before each consultation.; The questionnaire that will be used to measure HRQoL is EORTC C30 QLQ. EORTC C30 QLQ is a disease specific questionnaire which can be used to assess HRQoL in patients diagnosed with cancer

Secondary Outcome Measures

Name	Time	Method
Symptoms of hematological disease	Symptoms of disease will be assessed every 2, 3, 4 or 6 month, up to 18 months	Data on symptoms of disease will be collected before each consultation using an international validated questionnaire.; The questionnaire which will be used is: Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF)
Symptoms of depression and anxiety	Symptoms of depression and anxiety will be assessed every 2, 3, 4 or 6 month, up to 18 months	Data on symptoms of depression and anxiety will be collected before and after each consultation using an international validated questionnaire.; The questionnaire which will be used is: Hospital Depression and Anxiety Scale (HADS)

Trial Locations

Locations (1)

Aalborg University Hospital, Department of Hematology; 🇩🇰 Aalborg, Denmark