Back to resultsSystematic Symptom Identification With Disease Specific PROM to Assess Symptoms of Chronic GVHD in Outpatient Care in Patients Post HSCT (SIMPly-CARE)
Primary Purpose
GVHD, Chronic, Hematological Malignancy
Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Lee Symptom Scala
Sponsored by
About this trial
This is an interventional supportive care trial for GVHD, Chronic focused on measuring Lee Symptom Scale, Symptom management, Patient reported outcome
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.
Sites / Locations
- Rigshospitalet
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Symptom management with Lee Symptom Scale
Arm Description
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.
Outcomes
Primary Outcome Measures
Recruitment rate
Number of participants included from eligible participants
Adherence to intervention
Number of visits completed out of planned visits during intervention
Secondary Outcome Measures
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
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
MD Andersons Symptom Inventory (MDASI)
Change in symptom burden measured by the scale M.D. Andersons Symptom Inventory
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
Full Information
NCT ID
NCT04884204
First Posted
April 30, 2021
Last Updated
July 14, 2022
Sponsor
Rigshospitalet, Denmark
Collaborators
Novo Nordisk A/S
1. Study Identification
Unique Protocol Identification Number
NCT04884204
Brief Title
Systematic Symptom Identification With Disease Specific PROM to Assess Symptoms of Chronic GVHD in Outpatient Care in Patients Post HSCT
Acronym
SIMPly-CARE
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
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 30, 2021 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
May 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Novo Nordisk A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
GVHD, Chronic, Hematological Malignancy
Keywords
Lee Symptom Scale, Symptom management, Patient reported outcome
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Symptom management with Lee Symptom Scale
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Lee Symptom Scala
Intervention Description
Symptom identification and management with Lee Symptom Scale in follow up care
Primary Outcome Measure Information:
Title
Recruitment rate
Description
Number of participants included from eligible participants
Time Frame
Recruiment time frame: 12 months
Title
Adherence to intervention
Description
Number of visits completed out of planned visits during intervention
Time Frame
Intervention time frame: 12 months of follow up
Secondary Outcome Measure Information:
Title
Quality of life measured by the European Organization for Research and Treatment of Cancer - quality of life questionnaire C30 (EORTC-QLQ-C30)
Description
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
Title
Depression and Anxiety measured with the Hospital Anxiety and Depression Scale
Description
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
Title
MD Andersons Symptom Inventory (MDASI)
Description
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
Title
HM-PRO questionaire developed by the 'Scientific Working Group for QoL and Symptoms,' within the European Hematology Association
Description
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
Other Pre-specified Outcome Measures:
Title
Diagnose
Description
Diagnose at baseline
Time Frame
At baseline
Title
Medication
Description
Medication at baseline
Time Frame
At baseline
Title
Immunosuppresive drugs
Description
Immunosuppresive drugs the participants receive after transplantation (within the study period)
Time Frame
12 months of follow up from date of transplantation
Title
Hospitalization
Description
Periods with hospitalizations within the study period
Time Frame
12 months of follow up from date of transplantation
Title
Referrals to other hospital departments
Description
Number of referrals to other hospital departments within the study period
Time Frame
12 months of follow up from date of transplantation
Title
Referrals to general practitioner
Description
Number referrals to general practitioner within the study period
Time Frame
12 months of follow up from date of transplantation
Title
Referrals to municipality
Description
Number of referrals to rehabilitation in the municipality within the study period
Time Frame
12 months of follow up from date of transplantation
Title
Infections treated with antibiotics
Description
Number of infections treated with antibiotics within the study period
Time Frame
12 months of follow up from date of transplantation
Title
Number of telephone contacts to Dept. of Hematology
Description
Number of telephone contacts to Dept. of Hematology within the study period
Time Frame
12 months of follow up from date of transplantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Jarden
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Systematic Symptom Identification With Disease Specific PROM to Assess Symptoms of Chronic GVHD in Outpatient Care in Patients Post HSCT
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