Multidisciplinary Follow-up of Patients Treated for Malignant Hematological Disease

NCT03031106 | Unknown

• 1 other identifier: TVO
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Hematologic Neoplasm

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (2)

• Symptoms of depression and anxiety

  Symptoms of depression and anxiety will be assessed every 2, 3, 4 or 6 month, up to 18 months

• Symptoms of hematological disease

  Symptoms of disease will be assessed every 2, 3, 4 or 6 month, up to 18 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated with chemotherapy for primary hematological disease and patients followed in a Wait \& Watch regimen

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University Hospital: lead

Study Sites (1)

Aalborg University Hospital, Department of Hematology

Aalborg, 9000, Denmark

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Mia Sommer, MHSc

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mia Sommer, MHsc

CONTACT

0045 9766 0896; m.sommer@rn.dk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Nurse, ph.d. student

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: January 25, 2017
• Study Start: January 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: June 30, 2019
• Last Updated: March 2, 2018

Record last verified: 2018-03

Locations

DK (1)