Symptom Identification and Management in Patients With Hematological Malignancy During Follow-up Care
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Hematologic Malignancy
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Two armed randomized controlled trialMasking: Single (Outcomes Assessor)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Design: A two-arm prospective randomized controlled trial. Population: Patients diagnosed with chronic myeloid leukemia (CML), clonal cytopenia of unknown significance (CCUS), myelodysplastic syndrome (MDS) or myeloproliferative neoplasia (MPN). Patients will be recruited from the outpatient clinic ...
Design: A two-arm prospective randomized controlled trial. Population: Patients diagnosed with chronic myeloid leukemia (CML), clonal cytopenia of unknown significance (CCUS), myelodysplastic syndrome (MDS) or myeloproliferative neoplasia (MPN). Patients will be recruited from the outpatient clinic at the Dept. of Hematology at Rigshospitalet in Denmark. Patients will be identified and screened by their physician. Patients who are eligible for study inclusion will hereafter be approached, informed and recruited by the primary research investigator. Included patients will be randomized and allocated 1:1 to an intervention group or a control group. The intervention group will have a predetermined consultation appointment planned to assess medical status and symptom control. Seven days prior to the scheduled visit, the patient will receive an electronic invitation via RedCap to complete and send PRO data (HM-PRO). Prior to each appointment PRO data will be evaluated by a nurse from an algorithm deciding one of three tracks for the patients. The control group will receive standard care in the outpatient clinic. The patient has a predetermined consultation appointment at the hospital one time a year with a doctor to evaluate medical status and symptom control. Data Collection: The questionnaires will be distributed and completed by patients electronically via REDCap consisting of clinical data, PRO data (HM-PRO) and endpoint measures (see below). Primary outcome: Change in QoL measured by EORTC-QLQ-C30, global health domain, at 12 months. Secondary outcomes: Change in symptoms of depression and anxiety measured by HADS, change in symptom burden measured by MDASI symptom scale and clinical data outcomes at 12 months.
Tracking Information
- NCT #
- NCT04757545
- Collaborators
- Novo Nordisk A/S
- Investigators
- Principal Investigator: Maja Pedersen, Ph.d. stud. Rigshospitalet, Denmark
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