Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lee Symptom Scala | Behavioral | Symptom identification and management with Lee Symptom Scale in follow up care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | Number of participants included from eligible participants | Recruiment time frame: 12 months |
| Adherence to intervention | Number of visits completed out of planned visits during intervention | Intervention time frame: 12 months of follow up |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months; at baseline (0 months), 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnose | Diagnose at baseline | At baseline |
| Medication | Medication at baseline | At baseline |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mary Jarden | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | 2100 | Denmark |
Not provided
| ID | Term |
|---|---|
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| 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 | 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 | 12 months; at baseline (0 months), 3, 6, 9 and 12 months |
| Immunosuppresive drugs | Immunosuppresive drugs the participants receive after transplantation (within the study period) | 12 months of follow up from date of transplantation |
| Hospitalization | Periods with hospitalizations within the study period | 12 months of follow up from date of transplantation |
| Referrals to other hospital departments | Number of referrals to other hospital departments within the study period | 12 months of follow up from date of transplantation |
| Referrals to general practitioner | Number referrals to general practitioner within the study period | 12 months of follow up from date of transplantation |
| Referrals to municipality | Number of referrals to rehabilitation in the municipality within the study period | 12 months of follow up from date of transplantation |
| Infections treated with antibiotics | Number of infections treated with antibiotics within the study period | 12 months of follow up from date of transplantation |
| Number of telephone contacts to Dept. of Hematology | Number of telephone contacts to Dept. of Hematology within the study period | 12 months of follow up from date of transplantation |
| D001982 |
| Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |