Malignant Hematologic NeoplasmNCT03031106
Multidisciplinary Follow-up of Patients Treated for Malignant Hematological Disease
An observational study of Malignant Hematologic Neoplasm, run by Aalborg University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Hematologic Neoplasm
- How many people
- 300 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2017to 30 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with chemotherapy for primary hematological disease and patients followed in a Wait \& Watch regimen
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Aalborg University Hospital, Department of Hematology
Aalborg, 9000
Mia Sommer, MHSc, +45 9766 0896, m.sommer@rn.dk
Lise T Elkjær, +45 9766 3871, lit@rn.dk
About this study
Official title: 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.
- Conditions
- Malignant Hematologic Neoplasm
- Keywords
- Patient-reported outcomes, Health-related QoL, Internet-based tool
- Medical subject headings
- Hematologic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: HRQoL is assessed every 2, 3, 4 or 6 months, up to 18 months.
Secondary outcomes (2)
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)
Measured: 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)
Measured: Symptoms of disease will be assessed every 2, 3, 4 or 6 month, up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJul 2018 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Hematologic NeoplasmStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mia Sommer, Aalborg University Hospital
- Investigators
- Mia Sommer, MHSc, Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03031106
- Sponsor's protocol ID
- TVO
- Status last verified
- Mar 2018
- First submitted
- 12 Jan 2017
- Last updated
- 2 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Follow-up of Patients Treated for Malignant Hematological Disease; Focus on the Patient's Preferences and Life Situation
- ClinicalTrials.gov ID
- NCT03031106
- Acronym / sponsor ID
- TVO
- Conditions
- Malignant Hematologic Neoplasm
- Keywords
- Patient-reported outcomes, Health-related QoL, Internet-based tool
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 25 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with chemotherapy for primary hematological disease and patients followed in a Wait \& Watch regimen
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
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
Symptoms of hematological disease
Time frame: Symptoms of disease will be assessed every 2, 3, 4 or 6 month, up to 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mia Sommer, MHSc principal investigator
Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Hematologic Neoplasm, run by Aalborg University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mia Sommer, MHsc (0045 9766 0896, m.sommer@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-Related Quality of Life (HRQoL) - General (time frame: HRQoL is assessed every 2, 3, 4 or 6 months, up to 18 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2018.