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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

Tracking Information
First Submitted Date January 12, 2017
First Posted Date January 25, 2017
Last Update Posted Date March 2, 2018
Actual Study Start Date January 2017
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 3, 2017)
  • 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.
  • 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
Original Primary Outcome Measures
 (submitted: January 23, 2017)
  • Health-Related Quality of Life (HRQoL) - General [ Time Frame: HRQoL is assessed every 3 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 [ Time Frame: HRQoL is assessed every 3 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
Change History Complete list of historical versions of study NCT03031106 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 1, 2018)
  • 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)
  • 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)
Original Secondary Outcome Measures
 (submitted: January 23, 2017)
Symptoms of depression and anxiety [ Time Frame: Symptoms of depression and anxiety will be assessed every 3 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Multidisciplinary Follow-up of Patients Treated for Malignant Hematological Disease
Official Title Multidisciplinary Follow-up of Patients Treated for Malignant Hematological Disease; Focus on the Patient's Preferences and Life Situation
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients treated with chemotherapy for primary hematological disease and patients followed in a Wait & Watch regimen
Condition Malignant Hematologic Neoplasm
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 23, 2017)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2019
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Mia Sommer, MHsc 0045 9766 0896 m.sommer@rn.dk
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT03031106
Other Study ID Numbers TVO
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Mia Sommer, Aalborg University Hospital
Study Sponsor Aalborg University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Mia Sommer, MHSc Aalborg University Hospital
PRS Account Aalborg University Hospital
Verification Date March 2018