SIMPly-CARE: Symptom Identification and Management in Patients With Hematological Malignancy During Follow-up Care
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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).
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Primary outcome: Change in QoL measured by EORTC-QLQ-C30, global health domain, at 12 months.
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 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. |
Other: 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:
Worsening in symptoms results in a nurse-led telephone consultation within two days guided by the symptom management manual.
Minor changes in patient's symptom assessment result in a nurse-led telephone consultation within seven days using the symptom management manual.
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.
|
| No Intervention: 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. |
Outcome Measures
Primary Outcome Measures
- Change in Health related quality og life: EORTC QLQ C30 [At 12 months]
The global health domain
Secondary Outcome Measures
- 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 [Date for time of diagnosis - collected at baseline]
Time of diagnosis - date
- Clinical outcome [Hospitalization during intervention period baseline - 12 months]
Frequency/dates and length of hospitalization
- Clinical outcome [Number and charecter of referrals during interventions period baseline - 12 months]
Referrals to other departments and/or primary care in the municipality
- Clinical outcome [From baseline - 12 months]
Add on medication
- Clinical medication [Baseline]
Medication at baseline
- Clinical outcome [From baseline -12 months]
Number of consultations in follow-up in dept. of hematology
- Clinical outcome [Baseline, 6 and 12 months]
CPR - from laboratory test
Eligibility Criteria
Criteria
Inclusion Criteria:
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adults > 18 years
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diagnosed and undergoing follow up for a hematological malignancy in the outpatient clinic, Rigshospitalet
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The patients can be included approximately six months after initial diagnosis if in stable condition.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dept. of Hematology | Copenhagen | Denmark | 2100 |
Sponsors and Collaborators
- Rigshospitalet, Denmark
- Novo Nordisk A/S
Investigators
- Principal Investigator: Maja Pedersen, Ph.d. stud., Rigshospitalet, Denmark
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- University Hospital Copenhagen