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Multidisciplinary Follow-up of Patients Treated for Malignant Hematological Disease

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ClinicalTrials.gov Identifier: NCT03031106
Recruitment Status : Recruiting
First Posted : January 25, 2017
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
Mia Sommer, 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.

Condition or disease
Malignant Hematologic Neoplasm

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Multidisciplinary Follow-up of Patients Treated for Malignant Hematological Disease; Focus on the Patient's Preferences and Life Situation
Actual Study Start Date : January 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Disorders




Primary Outcome Measures :
  1. Health-Related Quality of Life (HRQoL) - General [ Time Frame: 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.


  2. Health-Related Quality of Life (HRQoL) - Disease specific [ Time Frame: 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 :
  1. Symptoms of depression and anxiety [ Time Frame: 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)


  2. Symptoms of hematological disease [ Time Frame: 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)




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated with chemotherapy for primary hematological disease and patients followed in a Wait & Watch regimen
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03031106


Contacts
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Contact: Mia Sommer, MHsc 0045 9766 0896 m.sommer@rn.dk

Locations
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Denmark
Aalborg University Hospital, Department of Hematology Recruiting
Aalborg, Denmark, 9000
Contact: Mia Sommer, MHSc    +45 9766 0896    m.sommer@rn.dk   
Contact: Lise T Elkjær    +45 9766 3871    lit@rn.dk   
Principal Investigator: Mia Sommer, MHSc         
Sponsors and Collaborators
Aalborg University Hospital
Investigators
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Principal Investigator: Mia Sommer, MHSc Aalborg University Hospital

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Responsible Party: Mia Sommer, Clinical Research Nurse, ph.d. student, Aalborg University Hospital
ClinicalTrials.gov Identifier: NCT03031106     History of Changes
Other Study ID Numbers: TVO
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Mia Sommer, Aalborg University Hospital:
Patient-reported outcomes, Health-related QoL, Internet-based tool
Additional relevant MeSH terms:
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Hematologic Neoplasms
Hematologic Diseases
Neoplasms by Site
Neoplasms