Clinical trial NCT04757545: Symptom Identification and Management in Patients With Hematological Malignancy During Follow-up Care
Official title: Symptom Identification and Management in Patiens With Hematological Malignacy - A Randomized Controlled Trial Using HM-PRO
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematologic Malignancy
Keywords: HM-PRO
Symptom management
Patient reported outcome
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
First posted: 2021-02-17
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two armed randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Health related quality og life: EORTC QLQ C30
timeFrame: At 12 months
Secondary outcomes:
measure: Changes in symptoms of depression and anxiety measured by HADS
timeFrame: 6 and 12 months
measure: Changes in symptom burden measured by MDASI symptom scale
timeFrame: 6 and 12 months
measure: Clinical outcomes
timeFrame: At baseline
measure: Patient experiences measured at PREM
timeFrame: 6 and 12 months
measure: Clinical outcome
timeFrame: Date for time of diagnosis - collected at baseline
measure: Clinical outcome
timeFrame: Hospitalization during intervention period baseline - 12 months
measure: Clinical outcome
timeFrame: Number and charecter of referrals during interventions period baseline - 12 months
measure: Clinical outcome
timeFrame: From baseline - 12 months
measure: Clinical medication
timeFrame: Baseline
measure: Clinical outcome
timeFrame: From baseline -12 months
measure: Clinical outcome
timeFrame: Baseline, 6 and 12 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dept. of Hematology
Study officials:
affiliation: Rigshospitalet, Denmark
name: Maja Pedersen, Ph.d. stud.
role: PRINCIPAL_INVESTIGATOR
References: