Systematic Symptom Identification With Disease Specific PROM to Assess Symptoms of Chronic GVHD in Outpatient Care in Patients Post HSCT
NCT ID: NCT04884204
Last Updated: 2023-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
35 participants
INTERVENTIONAL
2021-04-30
2023-07-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Symptom management with Lee Symptom Scale
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.
Lee Symptom Scala
Symptom identification and management with Lee Symptom Scale in follow up care
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lee Symptom Scala
Symptom identification and management with Lee Symptom Scale in follow up care
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novo Nordisk A/S
INDUSTRY
Rigshospitalet, Denmark
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mary Jarden
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mary Jarden
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Rigshospitalet
Copenhagen, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Copenhagen, Rigshospitalet
Identifier Type: -
Identifier Source: org_study_id