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

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.

Study Overview

• Status: Unknown
• Conditions: Malignant Hematologic Neoplasm

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Recruiting
    • Aalborg University Hospital, Department of Hematology
    • Contact: Mia Sommer, MHSc; Phone Number: +45 9766 0896; Email: m.sommer@rn.dk
    • Contact: Lise T Elkjær; Phone Number: +45 9766 3871; Email: lit@rn.dk
    • Principal Investigator: Mia Sommer, MHSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Aalborg University Hospital
• Investigators: Principal Investigator: Mia Sommer, MHSc, Aalborg University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): June 30, 2019

Study Registration Dates

• First Submitted: January 12, 2017
• First Submitted That Met QC Criteria: January 23, 2017
• First Posted (Estimate): January 25, 2017

Study Record Updates

• Last Update Posted (Actual): March 2, 2018
• Last Update Submitted That Met QC Criteria: March 1, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Patient-reported outcomes, Health-related QoL, Internet-based tool
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Neoplasms; Hematologic Diseases
• Other Study ID Numbers: TVO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided