GVHD, ChronicSIMPly-CARENCT04884204
Systematic Symptom Identification With Disease Specific PROM to Assess Symptoms of Chronic GVHD in Outpatient Care in Patients Post HSCT
A study testing Lee Symptom Scala in people with GVHD, Chronic and Hematological Malignancy, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GVHD, Chronic, Hematological Malignancy
- What is being tested?
- Lee Symptom Scala
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteDenmark
- Study dates
- 30 Apr 2021to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who do not understand, read and speak Danish and/or have cognitive/psychiatric disorders not compatible with inclusion in a clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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
- Conditions
- GVHD, Chronic, Hematological Malignancy
- Being tested
- Lee Symptom Scala
- Keywords
- Lee Symptom Scale, Symptom management, Patient reported outcome
- Medical subject headings
- Bronchiolitis Obliterans Syndrome, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lee Symptom ScalaBehavioural
Symptom identification and management with Lee Symptom Scale in follow up care
| Study group | Role | What they receive |
|---|---|---|
| Symptom management with Lee Symptom Scale | Experimental | 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. Receives: Behavioral: Lee Symptom Scala |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Number of participants included from eligible participants
Measured: Recruiment time frame: 12 months
Adherence to intervention
Number of visits completed out of planned visits during intervention
Measured: Intervention time frame: 12 months of follow up
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months; at baseline (0 months), 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start30 Apr 2021
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GVHD, ChronicStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Principal investigator, Mary Jarden, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Mary Jarden, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04884204
- Sponsor's protocol ID
- Copenhagen, Rigshospitalet
- Acronym
- SIMPly-CARE
- Status last verified
- Nov 2023
- First submitted
- 30 Apr 2021
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04884204
- Acronym / sponsor ID
- SIMPly-CARE / Copenhagen, Rigshospitalet
- Conditions
- GVHD, Chronic, Hematological Malignancy
- Keywords
- Lee Symptom Scale, Symptom management, Patient reported outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 12 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symptom management with Lee Symptom Scale | Experimental | Behavioral: Lee Symptom ScalaParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who do not understand, read and speak Danish and/or have cognitive/psychiatric disorders not compatible with inclusion in a clinical study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lee Symptom ScalaSymptom identification and management with Lee Symptom Scale in follow up care | Behavioural | Symptom management with Lee Symptom Scale |
Primary outcome
Recruitment rate
Time frame: Recruiment time frame: 12 months
Number of participants included from eligible participants
Adherence to intervention
Time frame: Intervention time frame: 12 months of follow up
Number of visits completed out of planned visits during intervention
4 secondary outcomes
Quality of life measured by the European Organization for Research and Treatment of Cancer - quality of life questionnaire C30 (EORTC-QLQ-C30)
Time frame: 12 months; at baseline (0 months), 6 and 12 months
Depression and Anxiety measured with the Hospital Anxiety and Depression Scale
Time frame: 12 months; at baseline (0 months), 6 and 12 months
MD Andersons Symptom Inventory (MDASI)
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
Time frame: 12 months; at baseline (0 months), 3, 6, 9 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Jarden principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lee Symptom Scala in people with GVHD, Chronic and Hematological Malignancy, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Recruiment time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.