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

Rigshospitalet, Denmark35 enrolled

Overview

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).

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

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

GVHD, Chronic Hematological Malignancy

Interventions

Lee Symptom ScalaBEHAVIORAL

Symptom identification and management with Lee Symptom Scale in follow up care

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Rigshospitalet

Copenhagen, Denmark

Outcomes

Primary Outcomes

Recruitment rate

Number of participants included from eligible participants

Time frame: Recruiment time frame: 12 months

Adherence to intervention

Number of visits completed out of planned visits during intervention

Time frame: Intervention time frame: 12 months of follow up

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 12 months; at baseline (0 months), 3, 6, 9 and 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.