Multidisciplinary Follow-up of Patients Treated for Malignant Hematological Disease

Multidisciplinary Follow-up of Patients Treated for Malignant Hematological Disease; Focus on the Patient's Preferences and Life Situation

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03031106

Enrollment

300

Registered

2017-01-25

Start date

2017-01-31

Completion date

2019-06-30

Last updated

2018-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Hematologic Neoplasm

Keywords

Patient-reported outcomes, Health-related QoL, Internet-based tool

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)
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)

Countries

Denmark

Contacts

Primary ContactMia Sommer, MHsc

m.sommer@rn.dk0045 9766 0896

Outcome results