Hematologic Malignancy
Conditions
Keywords
HM-PRO, Symptom management, Patient reported outcome
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.
Interventions
OTHERHM-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.
Sponsors
Novo Nordisk A/S
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Two armed randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Patients who do not understand, read and speak Danish and/or have cognitive/psychiatric disorders not compatible with inclusion in a clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Health related quality og life: EORTC QLQ C30 | At 12 months | The global health domain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in symptom burden measured by MDASI symptom scale | 6 and 12 months | MD Andersons Scale - core |
| Clinical outcomes | At baseline | Hematological diagnosis |
| Changes in symptoms of depression and anxiety measured by HADS | 6 and 12 months | Hospital Anxiety and Depression score |
| Clinical outcome | Date for time of diagnosis - collected at baseline | Time of diagnosis - date |
| Clinical medication | Baseline | Medication at baseline |
| Patient experiences measured at PREM | 6 and 12 months | Patient reported experience measures |
Countries
Denmark
Outcome results
None listed