Symptom Identification and Management in Patients With Hematological Malignancy During Follow-up Care (SIMPly-CARE)

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

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.

Study Overview

• Status: Completed
• Conditions: Hematologic Malignancy
• Intervention / Treatment: Other: HM-PRO

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.

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Dept. of Hematology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Novo Nordisk A/S
• Investigators: Principal Investigator: Maja Pedersen, Ph.d. stud., Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2021
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: February 12, 2021
• First Submitted That Met QC Criteria: February 12, 2021
• First Posted (Actual): February 17, 2021

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 26, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Patient reported outcome; Symptom management; HM-PRO
• Additional Relevant MeSH Terms: Neoplasms by Site; Hematologic Diseases; Neoplasms; Hematologic Neoplasms
• Other Study ID Numbers: University Hospital Copenhagen

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No