Symptom Identification and Management in Patients With Hematological Malignancy During Follow-up Care
NCT ID: NCT04757545
Last Updated: 2023-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
94 participants
INTERVENTIONAL
2021-02-08
2023-02-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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HM-PRO intervention
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.
HM-PRO
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:
1. Worsening in symptoms results in a nurse-led telephone consultation within two days guided by the symptom management manual.
2. Minor changes in patient's symptom assessment result in a nurse-led telephone consultation within seven days using the symptom management manual.
3. Patients that are completely stable in the symptom assessment will receive an electronic answer via min-SP (electronic patient journal) regarding the results and a new appointment, including PRO-data prior to this.
Standard outpatient follow-up care
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.
No interventions assigned to this group
Interventions
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HM-PRO
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:
1. Worsening in symptoms results in a nurse-led telephone consultation within two days guided by the symptom management manual.
2. Minor changes in patient's symptom assessment result in a nurse-led telephone consultation within seven days using the symptom management manual.
3. Patients that are completely stable in the symptom assessment will receive an electronic answer via min-SP (electronic patient journal) regarding the results and a new appointment, including PRO-data prior to this.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Rigshospitalet, Denmark
OTHER
Responsible Party
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Mary Jarden
Professor
Principal Investigators
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Maja Pedersen, Ph.d. stud.
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Locations
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Dept. of Hematology
Copenhagen, , Denmark
Countries
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References
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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.
Other Identifiers
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University Hospital Copenhagen
Identifier Type: -
Identifier Source: org_study_id