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

Hematologic Malignancy Clinical Trial

— SIMPly-CARE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04757545
• Other study ID #: University Hospital Copenhagen
• Status: Completed
• Phase: N/A
• Start date: February 8, 2021
• Est. completion date: February 1, 2023

Study information

• Verified date: November 2023
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Malignancy
• Hematologic Neoplasms
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Denmark	Dept. of Hematology	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Novo Nordisk A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Health related quality og life: EORTC QLQ C30	The global health domain	At 12 months
Secondary	Changes in symptoms of depression and anxiety measured by HADS	Hospital Anxiety and Depression score	6 and 12 months
Secondary	Changes in symptom burden measured by MDASI symptom scale	MD Andersons Scale - core	6 and 12 months
Secondary	Clinical outcomes	Hematological diagnosis	At baseline
Secondary	Patient experiences measured at PREM	Patient reported experience measures	6 and 12 months
Secondary	Clinical outcome	Time of diagnosis - date	Date for time of diagnosis - collected at baseline
Secondary	Clinical outcome	Frequency/dates and length of hospitalization	Hospitalization during intervention period baseline - 12 months
Secondary	Clinical outcome	Referrals to other departments and/or primary care in the municipality	Number and charecter of referrals during interventions period baseline - 12 months
Secondary	Clinical outcome	Add on medication	From baseline - 12 months
Secondary	Clinical medication	Medication at baseline	Baseline
Secondary	Clinical outcome	Number of consultations in follow-up in dept. of hematology	From baseline -12 months
Secondary	Clinical outcome	CPR - from laboratory test	Baseline, 6 and 12 months