Multidisciplinary Follow-up of Patients Treated for Malignant Hematological Disease

Malignant Hematologic Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03031106
• Other study ID #: TVO
• Status: Recruiting
• Phase: N/A
• First received: January 12, 2017
• Last updated: March 1, 2018
• Start date: January 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: March 2018
• Source: Aalborg Universitetshospital
• Contact: Mia Sommer, MHsc
• Phone: 0045 9766 0896
• Email: m.sommer[@]rn.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 30, 2019
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Diseases
• Hematologic Neoplasms
• Malignant Hematologic Neoplasm

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital, Department of Hematology	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg Universitetshospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health-Related Quality of Life (HRQoL) - General	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.	HRQoL is assessed every 2, 3, 4 or 6 months, up to 18 months.
Primary	Health-Related Quality of Life (HRQoL) - Disease specific	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	HRQoL is assessed every 2, 3, 4 or 6 months, up to 18 months.
Secondary	Symptoms of depression and anxiety	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 depression and anxiety will be assessed every 2, 3, 4 or 6 month, up to 18 months
Secondary	Symptoms of hematological disease	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 disease will be assessed every 2, 3, 4 or 6 month, up to 18 months