Symptom Identification and Management in Patients With Hematological Malignancy During Follow-up Care

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Symptom Identification and Management in Patiens With Hematological Malignacy - A Randomized Controlled Trial Using HM-PRO

Conditions
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Hematologic Malignancy

Intervention / Treatment
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* Other: HM-PRO


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two armed randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HM-PRO intervention<br>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<br>* 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.<br>|
| No Intervention: Standard outpatient follow-up care<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Health related quality og life: EORTC QLQ C30 | The global health domain | At 12 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HM-PRO, Symptom management, Patient reported outcome