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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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GVHD, Chronic, Hematological Malignancy

Intervention / Treatment
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* Behavioral: Lee Symptom Scala


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Symptom management with Lee Symptom Scale<br>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<br>* Symptom identification and management with Lee Symptom Scale in follow up care<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lee Symptom Scale, Symptom management, Patient reported outcome