Systematic Symptom Identification With Disease Specific PROM to Assess Symptoms of Chronic GVHD in Outpatient Care in Patients Post HSCT (SIMPly-CARE)

Systematic Symptom Identification With Disease Specific PROM to Assess Symptoms of Chronic GVHD in Outpatient Care in Patients Post HSCT - a Two Site Feasibility Study

A two sited feasibility study to test the feasibility of systematic symptom identification with disease specific and clinically developed PROM (Lee Symptom Scale) longitudinally with a 12 month follow up in outpatient care in patients post HSCT to assess symptoms of chronic GVHD (n= 30).

Study Overview

• Status: Completed
• Conditions: Hematological Malignancy; GVHD, Chronic
• Intervention / Treatment: Behavioral: Lee Symptom Scala

Detailed Description

A prospective, non-randomized, feasibility study examining a systematic approach to symptom management using PROMs with 12 months of follow up in hematological outpatient clinic

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet

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 old
• Approximately 3 months post HSCT (they will be included before HSCT, but the intervention will begin at 3 moths).
• Patients included needs to be able to manage a computer to receive and respond to collect PRO data.

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: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Symptom management with Lee Symptom Scale; Participants will receive disease specific questionnaires electronically, cGVHD-PRO (Lee Symtpom Scale), one week prior to their scheduled visit in the outpatient clinic. The participants will be asked to answer the questionnaire from home without any involvement from clinicians. Afterwards the PRO data will be used during the scheduled clinical consultations as an instrument to discover symptoms on chronic GVHD and systematically to monitoring symptoms developing over time.

Behavioral: Lee Symptom Scala; Symptom identification and management with Lee Symptom Scale in follow up care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	Number of participants included from eligible participants	Recruiment time frame: 12 months
Adherence to intervention	Number of visits completed out of planned visits during intervention	Intervention time frame: 12 months of follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life measured by the European Organization for Research and Treatment of Cancer - quality of life questionnaire C30 (EORTC-QLQ-C30)	Change in quality of life measured by the European Organization for Research and Treatment of Cancer - quality of life questionnaire C30	12 months; at baseline (0 months), 6 and 12 months
Depression and Anxiety measured with the Hospital Anxiety and Depression Scale	Change in symptoms of depression and anxiety measured by the Hospital Anxiety Depression Scale	12 months; at baseline (0 months), 6 and 12 months
MD Andersons Symptom Inventory (MDASI)	Change in symptom burden measured by the scale M.D. Andersons Symptom Inventory	12 months; at baseline (0 months), 6 and 12 months
HM-PRO questionaire developed by the 'Scientific Working Group for QoL and Symptoms,' within the European Hematology Association	Change in HM-PRO developed by The 'Scientific Working Group for QoL and Symptoms,' within the European Hematology Association	12 months; at baseline (0 months), 3, 6, 9 and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnose	Diagnose at baseline	At baseline
Medication	Medication at baseline	At baseline
Immunosuppresive drugs	Immunosuppresive drugs the participants receive after transplantation (within the study period)	12 months of follow up from date of transplantation
Hospitalization	Periods with hospitalizations within the study period	12 months of follow up from date of transplantation
Referrals to other hospital departments	Number of referrals to other hospital departments within the study period	12 months of follow up from date of transplantation
Referrals to general practitioner	Number referrals to general practitioner within the study period	12 months of follow up from date of transplantation
Referrals to municipality	Number of referrals to rehabilitation in the municipality within the study period	12 months of follow up from date of transplantation
Infections treated with antibiotics	Number of infections treated with antibiotics within the study period	12 months of follow up from date of transplantation
Number of telephone contacts to Dept. of Hematology	Number of telephone contacts to Dept. of Hematology within the study period	12 months of follow up from date of transplantation

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Novo Nordisk A/S
• Investigators: Principal Investigator: Mary Jarden, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2021
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: April 30, 2021
• First Submitted That Met QC Criteria: May 6, 2021
• First Posted (Actual): May 12, 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; Lee Symptom Scale
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: Copenhagen, Rigshospitalet

Drug and device information, study documents

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