Home Care in Allogeneic Haematopoietic Stem Cell Transplantation

Study Overview
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Brief Summary
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Mixed methods study with focus groups interviews and a prospective observational cohort study aimed to investigate the impact of advanced home care on transplant specific outcomes and quality of life in recipients of allogeneic hematopoietic stem cell transplantation

Detailed Description
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Study of advanced home care after allogeneic haematopoietic stem cell transplantation (allo-HSCT). The main objective is to investigate the impact of home care on transplant specific variables and quality of life (QoL). The main hypothesis is that home care patients will home care patients will have significantly better measured QoL than patients receiving in-hospital care during the first 6 weeks after allo-HSCT. The study will be conducted as part of routine care at the departement of haematology, Oslo University Hospital. There are qualitative and quantitative aspects to the study. The qualitative part involves focus groups interviews with patients that have been treated with allo-HSCT and have recieved home care and their caregivers. In the prospective observational cohort study data will be collected to compare patients receiving home care and patients treated in-hospital (control group). Patients in both groups wil answer the questionnaire EORTC QLQ-C30 once weekly for 6 weeks. In addition transplant- and treatment-specific variables will be collected and compares between the groups.

Official Title
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Impact of Home Care for Recipients of Allogeneic Haematopoietic Stem Cell Transplantation

Conditions
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Stem Cell Transplant Complications, GVH - Graft Versus Host Reaction, Quality of Life

Intervention / Treatment
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* Other: Home care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consent competency and written informed consent to participation Age ≥18 Understanding and willing to comply with written and oral instructions in Norwegian Planned treatment with allo-HSCT ECOG performance status 0-2 Caregiver (age ≥18) present 24 hours a day during the aplastic phase Travelling distance from residence to the hospital must be less than one hour. Exclusion Criteria: Not meeting inclusion criteria Uncontrolled infection or other medical condtion unsuitable for out patient care

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Home care|Advanced home care|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GRFS | GvHD-free, relapse-free survival | 1 year | 
| QoL | Quality of Life | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GvHD | Graft versus host disease | 1 year | 
| TRM | Transplant related mortality | 1 year | 
| Infection | Bacteriemia and invasive fungal disease | 1 year |