Systematic Symptom Identification With Disease Specific PROM to Assess Symptoms of Chronic GVHD in Outpatient Care in Patients Post HSCT

Hematological Malignancy Clinical Trial

— SIMPly-CARE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04884204
• Other study ID #: Copenhagen, Rigshospitalet
• Status: Completed
• Phase: N/A
• Start date: April 30, 2021
• Est. completion date: July 1, 2023

Study information

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

Clinical Trial Summary

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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• GVHD, Chronic
• Hematologic Neoplasms
• Hematological Malignancy

Intervention

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

Locations

Country	Name	City	State
Denmark	Rigshospitalet	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
Other	Diagnose	Diagnose at baseline	At baseline
Other	Medication	Medication at baseline	At baseline
Other	Immunosuppresive drugs	Immunosuppresive drugs the participants receive after transplantation (within the study period)	12 months of follow up from date of transplantation
Other	Hospitalization	Periods with hospitalizations within the study period	12 months of follow up from date of transplantation
Other	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
Other	Referrals to general practitioner	Number referrals to general practitioner within the study period	12 months of follow up from date of transplantation
Other	Referrals to municipality	Number of referrals to rehabilitation in the municipality within the study period	12 months of follow up from date of transplantation
Other	Infections treated with antibiotics	Number of infections treated with antibiotics within the study period	12 months of follow up from date of transplantation
Other	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
Primary	Recruitment rate	Number of participants included from eligible participants	Recruiment time frame: 12 months
Primary	Adherence to intervention	Number of visits completed out of planned visits during intervention	Intervention time frame: 12 months of follow up
Secondary	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
Secondary	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
Secondary	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
Secondary	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