- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03031106
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
Studieoversikt
Status
Forhold
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
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-
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Aalborg, Danmark, 9000
- Rekruttering
- Aalborg University Hospital, Department of Hematology
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Ta kontakt med:
- Mia Sommer, MHSc
- Telefonnummer: +45 9766 0896
- E-post: m.sommer@rn.dk
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Ta kontakt med:
- Lise T Elkjær
- Telefonnummer: +45 9766 3871
- E-post: lit@rn.dk
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Hovedetterforsker:
- Mia Sommer, MHSc
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Bare etui
- Tidsperspektiver: Potensielle
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Health-Related Quality of Life (HRQoL) - General
Tidsramme: 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. |
HRQoL is assessed every 2, 3, 4 or 6 months, up to 18 months.
|
|
Health-Related Quality of Life (HRQoL) - Disease specific
Tidsramme: 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 |
HRQoL is assessed every 2, 3, 4 or 6 months, up to 18 months.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Symptoms of depression and anxiety
Tidsramme: 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 depression and anxiety will be assessed every 2, 3, 4 or 6 month, up to 18 months
|
|
Symptoms of hematological disease
Tidsramme: 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) |
Symptoms of disease will be assessed every 2, 3, 4 or 6 month, up to 18 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Mia Sommer, MHSc, Aalborg University Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- TVO
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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