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

Not Applicable

Completed

• Conditions: GVHD, Chronic; Hematological Malignancy
• Interventions: Behavioral: Lee Symptom Scala

• Registration Number: NCT04884204
• Lead Sponsor: Rigshospitalet, Denmark

Brief 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).

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 Timeline

• Study Start: 2021-04-30
• Study First Submitted: 2021-04-30
• Study First Submitted QC: 2021-05-06
• Study First Posted: 2021-05-12
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-26
• Last Update Posted: 2023-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Symptom management with Lee Symptom Scale	Lee Symptom Scala	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark