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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HM-PRO intervention | Active Comparator | 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. |
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| Standard outpatient follow-up care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HM-PRO | Other | 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:
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Health related quality og life: EORTC QLQ C30 | The global health domain | At 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in symptoms of depression and anxiety measured by HADS | Hospital Anxiety and Depression score | 6 and 12 months |
| Changes in symptom burden measured by MDASI symptom scale | MD Andersons Scale - core |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maja Pedersen, Ph.d. stud. | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Hematology | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39954038 | Derived | Pedersen M, Larsen MT, Kornblit BT, Dahl EO, Lomborg K, Tolver A, Jarden M. Effects of nurse-led symptom management in chronic myeloid malignancies: a randomized trial. Support Care Cancer. 2025 Feb 15;33(3):196. doi: 10.1007/s00520-025-09230-1. |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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Two armed randomized controlled trial
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|
| 6 and 12 months |
| Clinical outcomes | Hematological diagnosis | At baseline |
| Patient experiences measured at PREM | Patient reported experience measures | 6 and 12 months |
| Clinical outcome | Time of diagnosis - date | Date for time of diagnosis - collected at baseline |
| Clinical outcome | Frequency/dates and length of hospitalization | Hospitalization during intervention period baseline - 12 months |
| Clinical outcome | Referrals to other departments and/or primary care in the municipality | Number and charecter of referrals during interventions period baseline - 12 months |
| Clinical outcome | Add on medication | From baseline - 12 months |
| Clinical medication | Medication at baseline | Baseline |
| Clinical outcome | Number of consultations in follow-up in dept. of hematology | From baseline -12 months |
| Clinical outcome | CPR - from laboratory test | Baseline, 6 and 12 months |