Clinical trial NCT04884204: Systematic Symptom Identification With Disease Specific PROM to Assess Symptoms of Chronic GVHD in Outpatient Care in Patients Post HSCT
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: GVHD, Chronic
Hematological Malignancy
Keywords: Lee Symptom Scale
Symptom management
Patient reported outcome
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
First posted: 2021-05-12
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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.

Primary outcomes:
measure: Recruitment rate
timeFrame: Recruiment time frame: 12 months
measure: Adherence to intervention
timeFrame: Intervention time frame: 12 months of follow up
Secondary outcomes:
measure: Quality of life measured by the European Organization for Research and Treatment of Cancer - quality of life questionnaire C30 (EORTC-QLQ-C30)
timeFrame: 12 months; at baseline (0 months), 6 and 12 months
measure: Depression and Anxiety measured with the Hospital Anxiety and Depression Scale
timeFrame: 12 months; at baseline (0 months), 6 and 12 months
measure: MD Andersons Symptom Inventory (MDASI)
timeFrame: 12 months; at baseline (0 months), 6 and 12 months
measure: HM-PRO questionaire developed by the 'Scientific Working Group for QoL and Symptoms,' within the European Hematology Association
timeFrame: 12 months; at baseline (0 months), 3, 6, 9 and 12 months
Other outcomes:
measure: Diagnose
timeFrame: At baseline
measure: Medication
timeFrame: At baseline
measure: Immunosuppresive drugs
timeFrame: 12 months of follow up from date of transplantation
measure: Hospitalization
timeFrame: 12 months of follow up from date of transplantation
measure: Referrals to other hospital departments
timeFrame: 12 months of follow up from date of transplantation
measure: Referrals to general practitioner
timeFrame: 12 months of follow up from date of transplantation
measure: Referrals to municipality
timeFrame: 12 months of follow up from date of transplantation
measure: Infections treated with antibiotics
timeFrame: 12 months of follow up from date of transplantation
measure: Number of telephone contacts to Dept. of Hematology
timeFrame: 12 months of follow up from date of transplantation
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Mary Jarden
role: PRINCIPAL_INVESTIGATOR
References: