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

Rigshospitalet, Denmark94 enrolled

Overview

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). * 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Hematologic Malignancy

Interventions

HM-PROOTHER

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Dept. of Hematology

Copenhagen, Denmark

Outcomes

Primary Outcomes

Change in Health related quality og life: EORTC QLQ C30

The global health domain

Time frame: At 12 months

Secondary Outcomes

Changes in symptoms of depression and anxiety measured by HADS

Hospital Anxiety and Depression score

Time frame: 6 and 12 months

Changes in symptom burden measured by MDASI symptom scale

MD Andersons Scale - core

Time frame: 6 and 12 months

Clinical outcomes

Hematological diagnosis

Time frame: At baseline

Patient experiences measured at PREM

Patient reported experience measures

Time frame: 6 and 12 months

Clinical outcome

Time of diagnosis - date

Time frame: Date for time of diagnosis - collected at baseline

Clinical outcome

Frequency/dates and length of hospitalization

Time frame: Hospitalization during intervention period baseline - 12 months

Clinical outcome

Referrals to other departments and/or primary care in the municipality

Time frame: Number and charecter of referrals during interventions period baseline - 12 months

Clinical outcome

Data from ClinicalTrials.gov

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