Symptom Identification and Management in Patients With Hematological Malignancy During Follow-up Care
- Conditions
- Hematologic Malignancy
- Interventions
- Other: HM-PRO
- Registration Number
- NCT04757545
- Lead Sponsor
- Rigshospitalet, Denmark
- Brief Summary
The aim is to study the effect of a systematic approach to symptom identification and management with disease specific and clinically developed PRO (HM-PRO) with a 12 month follow up in outpatient care in patients with chronic hematological malignancy.
- Detailed 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 94
- adults > 18 years
- diagnosed and undergoing follow up for a hematological malignancy in the outpatient clinic, Rigshospitalet
- The patients can be included approximately six months after initial diagnosis if in stable condition.
- able to manage an e-mail account
- Patients who do not understand, read and speak Danish and/or have cognitive/psychiatric disorders not compatible with inclusion in a clinical study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HM-PRO intervention HM-PRO The intervention group will have a predetermined nurseled consultation planned to assess medical status and symptom control at 0, 6 and 12 months. 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.
- Primary Outcome Measures
Name Time Method Change in Health related quality og life: EORTC QLQ C30 At 12 months The global health domain
- Secondary Outcome Measures
Name Time Method Changes in symptoms of depression and anxiety measured by HADS 6 and 12 months Hospital Anxiety and Depression score
Changes in symptom burden measured by MDASI symptom scale 6 and 12 months MD Andersons Scale - core
Clinical outcomes At baseline Hematological diagnosis
Patient experiences measured at PREM 6 and 12 months Patient reported experience measures
Clinical outcome Baseline, 6 and 12 months CPR - from laboratory test
Clinical medication Baseline Medication at baseline
Trial Locations
- Locations (1)
Dept. of Hematology
🇩🇰Copenhagen, Denmark